Breast Cancer Female, Physical Activity
Conditions
Brief summary
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Interventions
BEHAVIORALCore
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
BEHAVIORALSupport Calls
Participants will receive 6 bi-weekly phone calls from study staff.
BEHAVIORALApp+
Participants will receive deluxe version of smartphone app with additional features.
BEHAVIORALOnline gym
Participants will receive access to online exercise videos.
BEHAVIORALApp notifications
Participants will receive motivational app notifications
BEHAVIORALBuddy
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with Stage I-III breast cancer within the last 5 years 2. Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment 3. English speaking 4. Currently participate in less than 60 minutes of moderate and vigorous physical activity per week 5. Own a smartphone 6. Have access to a computer with Internet 7. Participants may be using adjuvant endocrine therapies. 8. Willing to be waitlisted for future wave if current wave reaches capacity
Exclusion criteria
-Women will be excluded if they report any of the following: 1. Respiratory, joint or cardiovascular problems precluding physical activity 2. Metastatic disease 3. Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery). ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION: 1. A prior cardiovascular event (i.e. stroke, myocardial infarction) 2. Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to a 12 Week Technology Supported Physical Activity Intervention | 12 weeks | Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12. |
| Participant Retention | 12 weeks | Percentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\]. |
| Intervention Reach | Baseline | Percentage of individuals randomized of those who were sent a study screening survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Change from baseline to 24 weeks | Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
| Change in Physical Function From Before to After a 12-Week Intervention | Change from baseline to 12 weeks | Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
| Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Change from baseline to 24 weeks | Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off. |
| Change in Depression From Before to After a 12-Week Intervention | Change from baseline to 12 weeks | Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
| Change in Depression From Pre-Intervention to 24-week Follow-up | Change from baseline to 24 weeks | Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
| Adherence to During the Full 24-Week Study Period | 24 weeks | Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24. |
| Participant Retention at 24 Week Follow-up | 24 weeks | Percentage of participants retained at 24 weeks of those randomized |
| Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Change from baseline to 12 weeks | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol. |
| Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. |
| Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Change from baseline to 12 weeks | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. |
| Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Change from baseline to 12 weeks | Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). |
| Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Change from baseline to 12 weeks | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better. |
| Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better. |
| Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Change from baseline to 12 weeks | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better. |
| Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better. |
| Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Change from baseline to 12 weeks | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
| Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better. |
| Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Change from baseline to 12 weeks | Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
| Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
| Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Change from baseline to 12 weeks | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
| Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Change from baseline to 24 weeks | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. |
| Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Change from baseline to 24 weeks | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects. |
| Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Change from baseline to 24 weeks | Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). |
| Change in Fatigue From Before to After a 12-Week Intervention | Change from baseline to 12 weeks | Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. |
Countries
United States
Participant flow
Pre-assignment details
A total of 280 women signed informed consent and enrolled in the study. However, in order to be randomized, participants must complete all baseline assessments. This includes wearing the accelerometer for a minimum of 5 valid days and completing all online questionnaires. A total of 269 women met the criteria for randomization.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Condition #1 core, support calls
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. | 8 |
| Experimental Condition #2 core, support calls, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features. | 9 |
| Experimental Condition #3 core, support calls, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #4 core, support calls, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos. | 8 |
| Experimental Condition #5 core, support calls, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications | 9 |
| Experimental Condition #6 core, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features. | 9 |
| Experimental Condition #7 core, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #8 core, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos. | 9 |
| Experimental Condition #9 core, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications | 9 |
| Experimental Condition #10 core, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #11 core, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #12 core, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #13 core, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos. | 8 |
| Experimental Condition #14 core, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #15 core, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #16 core, support calls, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #17 core, support calls, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos. | 8 |
| Experimental Condition #18 core, support calls, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #19 core, support calls, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #20 core, support calls, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #21 core, support calls, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #22 core, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #23 core, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #24 core, support calls, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Experimental Condition #25 core, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #26 core, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #27 core, support calls, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #28 core, support calls, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #29 core, support calls, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications | 8 |
| Experimental Condition #30 core
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. | 9 |
| Experimental Condition #31 core, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive deluxe version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 9 |
| Experimental Condition #32 core, support calls, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive deluxe version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 8 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental Condition #2 | Experimental Condition #1 | Experimental Condition #3 | Experimental Condition #4 | Experimental Condition #5 | Experimental Condition #6 | Experimental Condition #7 | Experimental Condition #8 | Experimental Condition #9 | Experimental Condition #10 | Experimental Condition #11 | Experimental Condition #12 | Experimental Condition #13 | Experimental Condition #14 | Experimental Condition #15 | Experimental Condition #16 | Experimental Condition #17 | Experimental Condition #18 | Experimental Condition #19 | Experimental Condition #20 | Experimental Condition #21 | Experimental Condition #22 | Experimental Condition #23 | Experimental Condition #24 | Experimental Condition #25 | Experimental Condition #26 | Experimental Condition #27 | Experimental Condition #28 | Experimental Condition #29 | Experimental Condition #30 | Experimental Condition #31 | Experimental Condition #32 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 12.2 | 51.5 years STANDARD_DEVIATION 10 | 52.4 years STANDARD_DEVIATION 9.6 | 58 years STANDARD_DEVIATION 5.4 | 54.6 years STANDARD_DEVIATION 9.4 | 49 years STANDARD_DEVIATION 7.9 | 53.1 years STANDARD_DEVIATION 9.8 | 49.1 years STANDARD_DEVIATION 7.3 | 50.8 years STANDARD_DEVIATION 5.8 | 57.3 years STANDARD_DEVIATION 9.9 | 55.6 years STANDARD_DEVIATION 12.7 | 52.1 years STANDARD_DEVIATION 9.6 | 48.9 years STANDARD_DEVIATION 9.1 | 51.3 years STANDARD_DEVIATION 9 | 53.6 years STANDARD_DEVIATION 10.4 | 53.6 years STANDARD_DEVIATION 9.1 | 60.4 years STANDARD_DEVIATION 9.7 | 54.5 years STANDARD_DEVIATION 13.4 | 55.7 years STANDARD_DEVIATION 11.3 | 55.1 years STANDARD_DEVIATION 7.1 | 54.5 years STANDARD_DEVIATION 8.1 | 49.5 years STANDARD_DEVIATION 7.2 | 46.9 years STANDARD_DEVIATION 13.2 | 60.3 years STANDARD_DEVIATION 9.4 | 50.2 years STANDARD_DEVIATION 11.3 | 53.1 years STANDARD_DEVIATION 8.7 | 53.8 years STANDARD_DEVIATION 12.2 | 49.4 years STANDARD_DEVIATION 8.6 | 53.1 years STANDARD_DEVIATION 13.5 | 52.9 years STANDARD_DEVIATION 11 | 50.8 years STANDARD_DEVIATION 5.5 | 42.4 years STANDARD_DEVIATION 9.1 | 52.9 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 6 Participants | 8 Participants | 7 Participants | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 4 Participants | 6 Participants | 7 Participants | 7 Participants | 6 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 9 Participants | 6 Participants | 244 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Number of Participants Randomized | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 269 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 7 Participants | 6 Participants | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 8 Participants | 4 Participants | 7 Participants | 8 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 7 Participants | 9 Participants | 7 Participants | 5 Participants | 6 Participants | 7 Participants | 9 Participants | 7 Participants | 7 Participants | 8 Participants | 7 Participants | 9 Participants | 8 Participants | 7 Participants | 234 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 8 Participants | 269 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 1 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 9 | 1 / 8 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 3 / 9 | 1 / 8 | 1 / 8 | 0 / 9 | 1 / 9 | 1 / 9 | 0 / 9 | 2 / 9 | 0 / 8 | 1 / 8 | 1 / 8 | 0 / 8 | 1 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 2 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 2 / 8 | 0 / 9 | 1 / 8 | 1 / 9 | 2 / 9 | 0 / 8 | 0 / 9 | 1 / 9 | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 8 | 0 / 9 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Time frame: 12 weeks
Population: All participants randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Reporting Groups | Adherence to a 12 Week Technology Supported Physical Activity Intervention | 93.0 Percentage of Days Fitbit Worn | Standard Deviation 12.7 |
Primary
Intervention Reach
Percentage of individuals randomized of those who were sent a study screening survey
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Reporting Groups | Intervention Reach | 50.8 Percentage of participants randomized |
Primary
Participant Retention
Percentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\].
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Reporting Groups | Participant Retention | 93.3 Percentage of participants retained |
Secondary
Adherence to During the Full 24-Week Study Period
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Time frame: 24 weeks
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Reporting Groups | Adherence to During the Full 24-Week Study Period | 80.0 Percentage of days the Fitbit was worn | Standard Deviation 25.8 |
Secondary
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 1.16 mg/dL | Standard Error 3.2 |
| All Reporting Groups | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Off Group Change | 4.06 mg/dL | Standard Error 2.76 |
| Buddy | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Off Group Change | 1.34 mg/dL | Standard Error 3.05 |
| Buddy | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 3.90 mg/dL | Standard Error 2.99 |
| App Notifications | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Off Group Change | 2.56 mg/dL | Standard Error 2.93 |
| App Notifications | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 2.68 mg/dL | Standard Error 3.07 |
| Online Gym | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Off Group Change | 1.40 mg/dL | Standard Error 2.79 |
| Online Gym | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 3.83 mg/dL | Standard Error 3.2 |
| App+ | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Off Group Change | 1.94 mg/dL | Standard Error 2.84 |
| App+ | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 3.29 mg/dL | Standard Error 3.16 |
| Core Intervention | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | On Group Change | 2.62 mg/dL | Standard Error 2.11 |
Secondary
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -3.13 mg/dL | Standard Error 3.45 |
| All Reporting Groups | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.04 mg/dL | Standard Error 3.03 |
| Buddy | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.06 mg/dL | Standard Error 3.3 |
| Buddy | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -3.03 mg/dL | Standard Error 3.19 |
| App Notifications | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -1.76 mg/dL | Standard Error 3.06 |
| App Notifications | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -1.33 mg/dL | Standard Error 3.43 |
| Online Gym | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -1.89 mg/dL | Standard Error 2.96 |
| Online Gym | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -1.20 mg/dL | Standard Error 3.53 |
| App+ | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -3.47 mg/dL | Standard Error 3.11 |
| App+ | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.38 mg/dL | Standard Error 3.38 |
| Core Intervention | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -1.55 mg/dL | Standard Error 2.31 |
Secondary
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.04 mg/L | Standard Error 0.19 |
| All Reporting Groups | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.18 mg/L | Standard Error 0.18 |
| Buddy | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.28 mg/L | Standard Error 0.19 |
| Buddy | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.14 mg/L | Standard Error 0.18 |
| App Notifications | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0 mg/L | Standard Error 0.19 |
| App Notifications | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.14 mg/L | Standard Error 0.18 |
| Online Gym | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Off Group Change | -0.08 mg/L | Standard Error 0.18 |
| Online Gym | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.22 mg/L | Standard Error 0.19 |
| App+ | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.16 mg/L | Standard Error 0.18 |
| App+ | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.02 mg/L | Standard Error 0.19 |
| Core Intervention | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.07 mg/L | Standard Error 0.13 |
Secondary
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.05 mg/L | Standard Error 0.2 |
| All Reporting Groups | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.22 mg/L | Standard Error 0.18 |
| Buddy | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.09 mg/L | Standard Error 0.19 |
| Buddy | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -0.09 mg/L | Standard Error 0.18 |
| App Notifications | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.12 mg/L | Standard Error 0.19 |
| App Notifications | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -0.06 mg/L | Standard Error 0.18 |
| Online Gym | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.21 mg/L | Standard Error 0.18 |
| Online Gym | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.01 mg/L | Standard Error 0.26 |
| App+ | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.10 mg/L | Standard Error 0.18 |
| App+ | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -0.07 mg/L | Standard Error 0.19 |
| Core Intervention | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -0.09 mg/L | Standard Error 0.13 |
Secondary
Change in Depression From Before to After a 12-Week Intervention
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -2.2 t-score on a scale | Standard Error 0.6 |
| All Reporting Groups | Change in Depression From Before to After a 12-Week Intervention | Off Group Change | -2.1 t-score on a scale | Standard Error 0.6 |
| Buddy | Change in Depression From Before to After a 12-Week Intervention | Off Group Change | -2.1 t-score on a scale | Standard Error 0.6 |
| Buddy | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -2.2 t-score on a scale | Standard Error 0.6 |
| App Notifications | Change in Depression From Before to After a 12-Week Intervention | Off Group Change | -1.7 t-score on a scale | Standard Error 0.6 |
| App Notifications | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -2.6 t-score on a scale | Standard Error 0.6 |
| Online Gym | Change in Depression From Before to After a 12-Week Intervention | Off Group Change | -2.5 t-score on a scale | Standard Error 0.6 |
| Online Gym | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -1.8 t-score on a scale | Standard Error 0.6 |
| App+ | Change in Depression From Before to After a 12-Week Intervention | Off Group Change | -2.2 t-score on a scale | Standard Error 0.6 |
| App+ | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -2.1 t-score on a scale | Standard Error 0.6 |
| Core Intervention | Change in Depression From Before to After a 12-Week Intervention | On Group Change | -2.2 t-score on a scale | Standard Error 0.4 |
Secondary
Change in Depression From Pre-Intervention to 24-week Follow-up
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 24 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.7 t-score on a scale | Standard Error 0.6 |
| All Reporting Groups | Change in Depression From Pre-Intervention to 24-week Follow-up | Off Group Change | -1.9 t-score on a scale | Standard Error 0.6 |
| Buddy | Change in Depression From Pre-Intervention to 24-week Follow-up | Off Group Change | -1.8 t-score on a scale | Standard Error 0.6 |
| Buddy | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.8 t-score on a scale | Standard Error 0.6 |
| App Notifications | Change in Depression From Pre-Intervention to 24-week Follow-up | Off Group Change | -1.9 t-score on a scale | Standard Error 0.6 |
| App Notifications | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.6 t-score on a scale | Standard Error 0.6 |
| Online Gym | Change in Depression From Pre-Intervention to 24-week Follow-up | Off Group Change | -1.9 t-score on a scale | Standard Error 0.6 |
| Online Gym | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.8 t-score on a scale | Standard Error 0.7 |
| App+ | Change in Depression From Pre-Intervention to 24-week Follow-up | Off Group Change | -1.8 t-score on a scale | Standard Error 0.6 |
| App+ | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.8 t-score on a scale | Standard Error 0.6 |
| Core Intervention | Change in Depression From Pre-Intervention to 24-week Follow-up | On Group Change | -1.8 t-score on a scale | Standard Error 0.4 |
Secondary
Change in Fatigue From Before to After a 12-Week Intervention
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -3.1 t-score on a scale | Standard Error 0.7 |
| All Reporting Groups | Change in Fatigue From Before to After a 12-Week Intervention | Off Group Change | -2.3 t-score on a scale | Standard Error 0.7 |
| Buddy | Change in Fatigue From Before to After a 12-Week Intervention | Off Group Change | -2.1 t-score on a scale | Standard Error 0.7 |
| Buddy | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -3.3 t-score on a scale | Standard Error 0.7 |
| App Notifications | Change in Fatigue From Before to After a 12-Week Intervention | Off Group Change | -2.6 t-score on a scale | Standard Error 0.7 |
| App Notifications | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -2.8 t-score on a scale | Standard Error 0.7 |
| Online Gym | Change in Fatigue From Before to After a 12-Week Intervention | Off Group Change | -3.2 t-score on a scale | Standard Error 0.7 |
| Online Gym | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -2.2 t-score on a scale | Standard Error 0.7 |
| App+ | Change in Fatigue From Before to After a 12-Week Intervention | Off Group Change | -3.3 t-score on a scale | Standard Error 0.7 |
| App+ | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -2.0 t-score on a scale | Standard Error 0.7 |
| Core Intervention | Change in Fatigue From Before to After a 12-Week Intervention | On Group Change | -2.7 t-score on a scale | Standard Error 0.5 |
Secondary
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 24 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -3.5 t-score on a scale | Standard Error 0.7 |
| All Reporting Groups | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Off Group Change | -3.7 t-score on a scale | Standard Error 0.7 |
| Buddy | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Off Group Change | -3.2 t-score on a scale | Standard Error 0.7 |
| Buddy | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -4.0 t-score on a scale | Standard Error 0.7 |
| App Notifications | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Off Group Change | -3.6 t-score on a scale | Standard Error 0.7 |
| App Notifications | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -3.6 t-score on a scale | Standard Error 0.7 |
| Online Gym | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Off Group Change | -3.9 t-score on a scale | Standard Error 0.7 |
| Online Gym | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -3.3 t-score on a scale | Standard Error 0.7 |
| App+ | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Off Group Change | -4.2 t-score on a scale | Standard Error 0.7 |
| App+ | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -3.0 t-score on a scale | Standard Error 0.7 |
| Core Intervention | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | On Group Change | -3.6 t-score on a scale | Standard Error 0.5 |
Secondary
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.37 mg/dL | Standard Error 4.2 |
| All Reporting Groups | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Off Group Change | -1.00 mg/dL | Standard Error 3.67 |
| Buddy | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Off Group Change | -4.05 mg/dL | Standard Error 4 |
| Buddy | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 3.43 mg/dL | Standard Error 3.87 |
| App Notifications | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Off Group Change | -5.82 mg/dL | Standard Error 3.87 |
| App Notifications | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 5.19 mg/dL | Standard Error 3.98 |
| Online Gym | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.55 mg/dL | Standard Error 3.74 |
| Online Gym | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 1.18 mg/dL | Standard Error 4.11 |
| App+ | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | Off Group Change | -4.53 mg/dL | Standard Error 3.83 |
| App+ | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 3.91 mg/dL | Standard Error 4.05 |
| Core Intervention | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.31 mg/dL | Standard Error 2.78 |
Secondary
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Off Group Change | -1.58 mg/dL | Standard Error 3.94 |
| All Reporting Groups | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 2.72 mg/dL | Standard Error 4.25 |
| Buddy | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 0.59 mg/dL | Standard Error 3.91 |
| Buddy | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Off Group Change | 0.55 mg/dL | Standard Error 4.29 |
| App Notifications | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 2.01 mg/dL | Standard Error 4.27 |
| App Notifications | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Off Group Change | -0.86 mg/dL | Standard Error 3.93 |
| Online Gym | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 0.51 mg/dL | Standard Error 4.37 |
| Online Gym | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Off Group Change | 0.64 mg/dL | Standard Error 3.83 |
| App+ | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 4.50 mg/dL | Standard Error 4.28 |
| App+ | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | Off Group Change | -3.36 mg/dL | Standard Error 3.92 |
| Core Intervention | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | On Group Change | 0.57 mg/dL | Standard Error 2.91 |
Secondary
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | 0.03 pg/mL | Standard Error 0.03 |
| All Reporting Groups | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Off Group Change | 0.12 pg/mL | Standard Error 0.05 |
| Buddy | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Off Group Change | 0.01 pg/mL | Standard Error 0.03 |
| Buddy | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | -0.01 pg/mL | Standard Error 0.03 |
| App Notifications | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Off Group Change | 0 pg/mL | Standard Error 0.03 |
| App Notifications | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | -0.01 pg/mL | Standard Error 0.03 |
| Online Gym | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Off Group Change | 0.02 pg/mL | Standard Error 0.03 |
| Online Gym | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | -0.02 pg/mL | Standard Error 0.04 |
| App+ | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Off Group Change | -0.03 pg/mL | Standard Error 0.03 |
| App+ | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | 0.03 pg/mL | Standard Error 0.03 |
| Core Intervention | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | On Group Change | 0 pg/mL | Standard Error 0.02 |
Secondary
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.11 pg/mL | Standard Error 0.04 |
| All Reporting Groups | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.01 pg/mL | Standard Error 0.03 |
| Buddy | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.07 pg/mL | Standard Error 0.03 |
| Buddy | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.04 pg/mL | Standard Error 0.03 |
| App Notifications | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.05 pg/mL | Standard Error 0.04 |
| App Notifications | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.06 pg/mL | Standard Error 0.04 |
| Online Gym | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.04 pg/mL | Standard Error 0.03 |
| Online Gym | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.06 pg/mL | Standard Error 0.04 |
| App+ | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.02 pg/mL | Standard Error 0.03 |
| App+ | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.08 pg/mL | Standard Error 0.04 |
| Core Intervention | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.05 pg/mL | Standard Error 0.02 |
Secondary
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.07 pg/mL | Standard Error 0.1 |
| All Reporting Groups | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.02 pg/mL | Standard Error 0.08 |
| Buddy | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.02 pg/mL | Standard Error 0.09 |
| Buddy | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.06 pg/mL | Standard Error 0.09 |
| App Notifications | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.01 pg/mL | Standard Error 0.09 |
| App Notifications | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.05 pg/mL | Standard Error 0.09 |
| Online Gym | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.05 pg/mL | Standard Error 0.07 |
| Online Gym | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.08 pg/mL | Standard Error 0.1 |
| App+ | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Off Group Change | -0.06 pg/mL | Standard Error 0.09 |
| App+ | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.01 pg/mL | Standard Error 0.09 |
| Core Intervention | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.02 pg/mL | Standard Error 0.06 |
Secondary
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6.In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.14 pg/mL | Standard Error 0.1 |
| All Reporting Groups | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.14 pg/mL | Standard Error 0.09 |
| Buddy | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.15 pg/mL | Standard Error 0.09 |
| Buddy | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.13 pg/mL | Standard Error 0.1 |
| App Notifications | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.18 pg/mL | Standard Error 0.09 |
| App Notifications | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.09 pg/mL | Standard Error 0.1 |
| Online Gym | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.22 pg/mL | Standard Error 0.08 |
| Online Gym | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.06 pg/mL | Standard Error 0.11 |
| App+ | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.10 pg/mL | Standard Error 0.09 |
| App+ | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.17 pg/mL | Standard Error 0.1 |
| Core Intervention | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.14 pg/mL | Standard Error 0.07 |
Secondary
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Time frame: Change from baseline to 12 weeks
Population: One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 57.9 Minutes per week | Standard Error 9.4 |
| All Reporting Groups | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Off Group Change | 49.3 Minutes per week | Standard Error 9 |
| Buddy | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Off Group Change | 51.7 Minutes per week | Standard Error 9.2 |
| Buddy | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 55.5 Minutes per week | Standard Error 9.2 |
| App Notifications | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Off Group Change | 47.6 Minutes per week | Standard Error 8.9 |
| App Notifications | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 59.8 Minutes per week | Standard Error 9.6 |
| Online Gym | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Off Group Change | 58.1 Minutes per week | Standard Error 35 |
| Online Gym | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 49.3 Minutes per week | Standard Error 9 |
| App+ | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Off Group Change | 63.5 Minutes per week | Standard Error 9.9 |
| App+ | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 44.3 Minutes per week | Standard Error 8.6 |
| Core Intervention | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | On Group Change | 53.6 Minutes per week | Standard Error 6.6 |
Secondary
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Time frame: Change from baseline to 24 weeks
Population: One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 28.5 Minutes per week | Standard Error 8 |
| All Reporting Groups | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Off Group Change | 49.3 Minutes per week | Standard Error 9 |
| Buddy | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Off Group Change | 23.4 Minutes per week | Standard Error 7.8 |
| Buddy | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 25.9 Minutes per week | Standard Error 7.9 |
| App Notifications | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Off Group Change | 24.0 Minutes per week | Standard Error 7.8 |
| App Notifications | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 25.3 Minutes per week | Standard Error 7.9 |
| Online Gym | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Off Group Change | 58.1 Minutes per week | Standard Error 35 |
| Online Gym | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 15.1 Minutes per week | Standard Error 7.3 |
| App+ | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Off Group Change | 34.2 Minutes per week | Standard Error 8.4 |
| App+ | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 15.8 Minutes per week | Standard Error 7.4 |
| Core Intervention | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | On Group Change | 24.6 Minutes per week | Standard Error 5.7 |
Secondary
Change in Physical Function From Before to After a 12-Week Intervention
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Time frame: Change from baseline to 12 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 2.4 t-score on a scale | Standard Error 0.4 |
| All Reporting Groups | Change in Physical Function From Before to After a 12-Week Intervention | Off Group Change | 1.6 t-score on a scale | Standard Error 0.4 |
| Buddy | Change in Physical Function From Before to After a 12-Week Intervention | Off Group Change | 1.7 t-score on a scale | Standard Error 0.4 |
| Buddy | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 2.3 t-score on a scale | Standard Error 0.4 |
| App Notifications | Change in Physical Function From Before to After a 12-Week Intervention | Off Group Change | 1.8 t-score on a scale | Standard Error 0.4 |
| App Notifications | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 2.2 t-score on a scale | Standard Error 0.4 |
| Online Gym | Change in Physical Function From Before to After a 12-Week Intervention | Off Group Change | 2.6 t-score on a scale | Standard Error 0.4 |
| Online Gym | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 1.4 t-score on a scale | Standard Error 0.4 |
| App+ | Change in Physical Function From Before to After a 12-Week Intervention | Off Group Change | 1.5 t-score on a scale | Standard Error 0.4 |
| App+ | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 2.5 t-score on a scale | Standard Error 0.4 |
| Core Intervention | Change in Physical Function From Before to After a 12-Week Intervention | On Group Change | 2.0 t-score on a scale | Standard Error 0.3 |
Secondary
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | -17.35 mg/dL | Standard Error 23.23 |
| All Reporting Groups | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Off Group Change | 25.43 mg/dL | Standard Error 19.72 |
| Buddy | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Off Group Change | 1.45 mg/dL | Standard Error 21.97 |
| Buddy | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | 6.63 mg/dL | Standard Error 20.99 |
| App Notifications | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Off Group Change | 23.04 mg/dL | Standard Error 20.63 |
| App Notifications | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | -14.96 mg/dL | Standard Error 22.55 |
| Online Gym | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Off Group Change | -20.00 mg/dL | Standard Error 20.42 |
| Online Gym | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | 28.08 mg/dL | Standard Error 22.52 |
| App+ | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Off Group Change | -0.93 mg/dL | Standard Error 21.46 |
| App+ | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | 9.01 mg/dL | Standard Error 21.33 |
| Core Intervention | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | On Group Change | 4.40 mg/dL | Standard Error 15.28 |
Secondary
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -10.81 mg/dL | Standard Error 23.82 |
| All Reporting Groups | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 43.01 mg/dL | Standard Error 20.76 |
| Buddy | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 27.05 mg/dL | Standard Error 22.82 |
| Buddy | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 5.15 mg/dL | Standard Error 21.59 |
| App Notifications | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 28.60 mg/dL | Standard Error 20.68 |
| App Notifications | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 3.60 mg/dL | Standard Error 24.16 |
| Online Gym | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 15.09 mg/dL | Standard Error 20.69 |
| Online Gym | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 17.12 mg/dL | Standard Error 23.82 |
| App+ | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 11.21 mg/dL | Standard Error 22 |
| App+ | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 20.99 mg/dL | Standard Error 22.32 |
| Core Intervention | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 16.10 mg/dL | Standard Error 15.8 |
Secondary
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Time frame: Change from baseline to 12 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | 0.22 pg/mL | Standard Error 0.17 |
| All Reporting Groups | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Off Group Change | -0.05 pg/mL | Standard Error 0.14 |
| Buddy | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.01 pg/mL | Standard Error 0.15 |
| Buddy | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.27 pg/mL | Standard Error 0.15 |
| App Notifications | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Off Group Change | -0.15 pg/mL | Standard Error 0.15 |
| App Notifications | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.11 pg/mL | Standard Error 0.16 |
| Online Gym | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Off Group Change | 0.01 pg/mL | Standard Error 0.13 |
| Online Gym | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.27 pg/mL | Standard Error 0.17 |
| App+ | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | Off Group Change | -0.10 pg/mL | Standard Error 0.15 |
| App+ | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.17 pg/mL | Standard Error 0.17 |
| Core Intervention | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | On Group Change | -0.13 pg/mL | Standard Error 0.11 |
Secondary
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Time frame: Change from baseline to 24 weeks
Population: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.22 pg/mL | Standard Error 0.17 |
| All Reporting Groups | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.05 pg/mL | Standard Error 0.14 |
| Buddy | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.03 pg/mL | Standard Error 0.15 |
| Buddy | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.14 pg/mL | Standard Error 0.16 |
| App Notifications | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.11 pg/mL | Standard Error 0.15 |
| App Notifications | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.07 pg/mL | Standard Error 0.17 |
| Online Gym | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | 0.20 pg/mL | Standard Error 0.13 |
| Online Gym | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | -0.03 pg/mL | Standard Error 0.18 |
| App+ | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | Off Group Change | -0.07 pg/mL | Standard Error 0.14 |
| App+ | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.24 pg/mL | Standard Error 0.17 |
| Core Intervention | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | On Group Change | 0.09 pg/mL | Standard Error 0.11 |
Secondary
Participant Retention at 24 Week Follow-up
Percentage of participants retained at 24 weeks of those randomized
Time frame: 24 weeks
Population: All participants randomized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Reporting Groups | Participant Retention at 24 Week Follow-up | 90 Percentage of participants retained |
Secondary
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Time frame: Change from baseline to 24 weeks
Population: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) on or off. Participants randomized to on are compared to those randomized to off. All participants get the core intervention so there is no comparison group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Reporting Groups | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.2 t-score on a scale | Standard Error 0.5 |
| All Reporting Groups | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Off Group Change | 2.0 t-score on a scale | Standard Error 0.5 |
| Buddy | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Off Group Change | 2.0 t-score on a scale | Standard Error 0.5 |
| Buddy | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.4 t-score on a scale | Standard Error 0.5 |
| App Notifications | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Off Group Change | 1.9 t-score on a scale | Standard Error 0.4 |
| App Notifications | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.4 t-score on a scale | Standard Error 0.5 |
| Online Gym | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Off Group Change | 2.4 t-score on a scale | Standard Error 0.5 |
| Online Gym | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.0 t-score on a scale | Standard Error 0.5 |
| App+ | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Off Group Change | 1.7 t-score on a scale | Standard Error 0.5 |
| App+ | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.7 t-score on a scale | Standard Error 0.5 |
| Core Intervention | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | On Group Change | 2.2 t-score on a scale | Standard Error 0.3 |