Insulin Resistance, Polycystic Ovary Syndrome, PreDiabetes, Type 2 Diabetes
Conditions
Brief summary
There is an urgent need to engineer targeted physical activity interventions that are effective and scalable for obese adolescents and young adults (AYA) with type 2 diabetes (T2D), who often have very low levels of physical activity. The BEAM Trial is a mobile health (mHealth) intervention that uses behavioral economic-informed financial incentives and text messaging to promote physical activity in AYA with T2D and prediabetes.
Detailed description
Some secondary outcome measures from the protocol were inadvertently left out when creating the registration and have been added with the results.
Interventions
BEHAVIORAL1RLD
1RLD=One text per day, ramped goal, loss incentive, daily goal time period
BEHAVIORAL1RLW
1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
BEHAVIORAL1RGD
1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
BEHAVIORAL1RGW
One text per day, ramped goal, gain incentive, weekly goal time period.
BEHAVIORAL2RLD
Two texts per day, ramped goal, loss incentive, daily goal time period.
BEHAVIORAL2RLW
Two texts per day, ramped goal, loss incentive, weekly goal time period.
BEHAVIORAL2RGD
Two texts per day, ramped goal, gain incentive, daily goal time period.
BEHAVIORAL2RGW
Two texts per day, ramped goal, gain incentive, weekly goal time period.
BEHAVIORAL1FLD
One text per day, fixed goal, loss incentive, daily weekly goal time period.
BEHAVIORAL1FLW
One text per day, fixed goal, loss incentive, weekly goal time period.
BEHAVIORAL1FGD
One text per day, fixed goal, gain incentive, daily goal time period.
BEHAVIORAL1FGW
One text per day, fixed goal, gain incentive, weekly goal time period.
BEHAVIORAL2FLD
Two texts per day, fixed goal, loss incentive, daily goal time period.
BEHAVIORAL2FLW
Two texts per day, fixed goal, loss incentive, weekly goal time period.
BEHAVIORAL2FGD
Two texts per day, fixed goal, gain incentive, daily goal time period.
BEHAVIORAL2FGW
Two texts per day, fixed goal, gain incentive, weekly goal time period.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* 1\) Males or females age 13 to 22 years. * 2\) Overweight or obese (BMI ≥85th percentile for age/sex, or ≥25 kg/m2 for participants ≥18 years) * 3\) Diagnosis with prediabetes or type 2 diabetes * 4\) Consent (subjects 18 and older), Parental/guardian permission (subjects 13-17), assent (subjects 13-17) * 5\) Willingness to wear Fitbit during waking hours daily for duration of run-in and intervention. * 6\) Possession of a smartphone.
Exclusion criteria
* 1\) Potential subject unable to speak or read in English * 2\) Severe cognitive impairment * 3\) Permanent or temporary physical disability that impairs ambulation or precludes engagement in MVPA * 4\) Current pregnancy * 5\) Previously-diagnosed or current restrictive or purging eating disorder * 6\) Moderate to vigorous physical activity (MVPA) \>30 minutes per day or Fitbit wear \< 4 days during second week of 2-week run-in period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Moderate to Vigorous Physical Activity (MVPA) | 12 weeks | Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI Z-score | From baseline to follow-up in-person study visits, separated by 3 months | Z-score calculated using zanthro package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity. |
| Change in Plasma Glucose | From baseline to follow-up in-person study visits, separated by 3 months | mg/dL; obtained fasting |
| Change in Insulin | From baseline to follow-up in-person study visits, separated by 3 months | uIU/mL; obtained fasting |
| Change in Hemoglobin A1c | From baseline to follow-up in-person study visits, separated by 3 months | Percent (%) |
| Change in Daily Step Count | 12 weeks | Daily step count will be measured by assessing the change in daily mean steps from baseline |
| Change in Low-density Lipoprotein (LDL) | From baseline to follow-up in-person study visits, separated by 3 months | mg/dL; obtained fasting |
| Change in High-density Lipoprotein (HDL) | From baseline to follow-up in-person study visits, separated by 3 months | mg/dL; obtained fasting |
| Change in ALT | From baseline to follow-up in-person study visits, separated by 3 months | U/L |
| Change in Triglycerides | From baseline to follow-up in-person study visits, separated by 3 months | mg/dL; obtained fasting |
Countries
United States
Participant flow
Pre-assignment details
n=75 participants signed consent to participate in the study. n=74 completed the baseline study visit and 2-week run-in using Fitbit. Those with insufficient Fitbit data or more than 30 minutes of moderate-vigorous physical activity daily were excluded prior to randomization (n=7).
Participants by arm
| Arm | Count |
|---|---|
| 1FLD One text per day, fixed goal, loss incentive, daily weekly goal time period. | 5 |
| 1FLW One text per day, fixed goal, loss incentive, weekly goal time period. | 4 |
| 1RLD One text per day, ramped goal, loss incentive, daily goal time period | 4 |
| 1RLW One text per day, ramped goal, loss incentive, weekly goal time period. | 5 |
| 1FGD One text per day, fixed goal, gain incentive, daily goal time period. | 4 |
| 1FGW One text per day, fixed goal, gain incentive, weekly goal time period. | 3 |
| 1RGD One text per day, ramped goal, gain incentive, daily goal time period. | 3 |
| 1RGW One text per day, ramped goal, gain incentive, weekly goal time period. | 4 |
| 2FLD Two texts per day, fixed goal, loss incentive, daily goal time period. | 4 |
| 2FLW Two texts per day, fixed goal, loss incentive, weekly goal time period. | 5 |
| 2RLD Two texts per day, ramped goal, loss incentive, daily goal time period. | 5 |
| 2RLW Two texts per day, ramped goal, loss incentive, weekly goal time period. | 4 |
| 2FGD Two texts per day, fixed goal, gain incentive, daily goal time period. | 4 |
| 2FGW Two texts per day, fixed goal, gain incentive, weekly goal time period. | 4 |
| 2RGD Two texts per day, ramped goal, gain incentive, daily goal time period. | 5 |
| 2RGW Two texts per day, ramped goal, gain incentive, weekly goal time period. | 4 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Did not attend final study visit but had Fitbit data | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Missing Fitbit data and lost to follow up | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 3 | 1 | 1 | 1 | 0 | 0 | 1 |
| Overall Study | Missing Fitbit data but not lost to follow up | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 4 | 0 | 1 | 0 | 0 | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | 2RGW | 2RGD | 2FGW | 2FGD | 2RLW | 2RLD | 2FLW | 2FLD | 1RGW | 1RGD | 1FGW | 1FGD | 1RLW | 1RLD | Total | 1FLW | 1FLD |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 15.8 years STANDARD_DEVIATION 2.5 | 16.1 years STANDARD_DEVIATION 1.3 | 14.1 years STANDARD_DEVIATION 0.9 | 16.0 years STANDARD_DEVIATION 0.6 | 17.2 years STANDARD_DEVIATION 3.2 | 17.7 years STANDARD_DEVIATION 2 | 16.3 years STANDARD_DEVIATION 1 | 17.5 years STANDARD_DEVIATION 2.5 | 17.0 years STANDARD_DEVIATION 2.7 | 16.7 years STANDARD_DEVIATION 3.3 | 15.2 years STANDARD_DEVIATION 1.9 | 15.9 years STANDARD_DEVIATION 1.6 | 15.0 years STANDARD_DEVIATION 1.3 | 15.3 years STANDARD_DEVIATION 1 | 16.1 years STANDARD_DEVIATION 2 | 15.2 years STANDARD_DEVIATION 2.6 | 16.1 years STANDARD_DEVIATION 1.8 |
| Body mass index | 34.5 kg/m^2 | 35.9 kg/m^2 | 35.5 kg/m^2 | 37.8 kg/m^2 | 40.2 kg/m^2 | 44.6 kg/m^2 | 34.7 kg/m^2 | 39.6 kg/m^2 | 42.1 kg/m^2 | 40.3 kg/m^2 | 38.3 kg/m^2 | 46.9 kg/m^2 | 34.9 kg/m^2 | 43.7 kg/m^2 | 40 kg/m^2 | 43.6 kg/m^2 | 38.4 kg/m^2 |
| Race/Ethnicity, Customized Hispanic/Latino/Latina | 0 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 | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiracial | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 9 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Asian | 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 | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 22 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Native American/Alaskan Native/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 | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 31 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 4 Participants | 45 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 22 Participants | 0 Participants | 1 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 2 / 5 | 1 / 4 | 2 / 4 | 1 / 5 | 0 / 4 | 2 / 3 | 1 / 3 | 2 / 4 | 2 / 4 | 1 / 5 | 1 / 5 | 2 / 4 | 0 / 4 | 2 / 4 | 0 / 5 | 2 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 | 0 / 3 | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
Change in Moderate to Vigorous Physical Activity (MVPA)
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
Time frame: 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Once Daily Text Message | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 6.1 minutes per day |
| Once Daily Text Message | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 2.3 minutes per day |
| Twice Daily Text Message | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 7.1 minutes per day |
| Twice Daily Text Message | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 1.8 minutes per day |
| Fixed Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 5.0 minutes per day |
| Fixed Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 3.3 minutes per day |
| Ramped Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 8.2 minutes per day |
| Ramped Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 0.8 minutes per day |
| Loss Framed Incentive | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 5.1 minutes per day |
| Loss Framed Incentive | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 4.0 minutes per day |
| Gain Framed Incentive | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 8.2 minutes per day |
| Gain Framed Incentive | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 0.07 minutes per day |
| Daily Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | -0.2 minutes per day |
| Daily Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 6.5 minutes per day |
| Weekly Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Baseline | 6.7 minutes per day |
| Weekly Step Count Goal | Change in Moderate to Vigorous Physical Activity (MVPA) | Change from baseline to 12 weeks | 4.3 minutes per day |
95% CI: [-6.2, 5.3]
95% CI: [-9.4, 4.6]
95% CI: [-11, 3.1]
95% CI: [-1, 9.8]
Secondary
Change in ALT
U/L
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight- or glucose-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in ALT | 0.000000004 U/L |
| Twice Daily Text Message | Change in ALT | 0.00000002 U/L |
| Fixed Step Count Goal | Change in ALT | 0.00002 U/L |
| Ramped Step Count Goal | Change in ALT | 0 U/L |
| Loss Framed Incentive | Change in ALT | 0 U/L |
| Gain Framed Incentive | Change in ALT | 0.00002 U/L |
| Daily Step Count Goal | Change in ALT | 0.000003 U/L |
| Weekly Step Count Goal | Change in ALT | 0 U/L |
95% CI: [-0.00002, 0.00002]
95% CI: [-0.03, 0.03]
95% CI: [-0.03, 0.03]
95% CI: [-0.004, 0.004]
Secondary
Change in BMI Z-score
Z-score calculated using zanthro package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity.
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). BMI Z-scores were not calculated for individuals older than 20 years (n=1)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Once Daily Text Message | Change in BMI Z-score | -0.02 Z-score |
| Twice Daily Text Message | Change in BMI Z-score | -0.03 Z-score |
| Fixed Step Count Goal | Change in BMI Z-score | -0.009 Z-score |
| Ramped Step Count Goal | Change in BMI Z-score | -0.03 Z-score |
| Loss Framed Incentive | Change in BMI Z-score | -0.03 Z-score |
| Gain Framed Incentive | Change in BMI Z-score | -0.01 Z-score |
| Daily Step Count Goal | Change in BMI Z-score | -0.02 Z-score |
| Weekly Step Count Goal | Change in BMI Z-score | -0.02 Z-score |
95% CI: [-0.05, 0.04]
95% CI: [-0.07, 0.02]
95% CI: [-0.02, 0.06]
95% CI: [-0.04, 0.04]
Secondary
Change in Daily Step Count
Daily step count will be measured by assessing the change in daily mean steps from baseline
Time frame: 12 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Daily Step Count | 962 steps |
| Twice Daily Text Message | Change in Daily Step Count | 276 steps |
| Fixed Step Count Goal | Change in Daily Step Count | 1789 steps |
| Ramped Step Count Goal | Change in Daily Step Count | -551 steps |
| Loss Framed Incentive | Change in Daily Step Count | 1266 steps |
| Gain Framed Incentive | Change in Daily Step Count | -28 steps |
| Daily Step Count Goal | Change in Daily Step Count | 687 steps |
| Weekly Step Count Goal | Change in Daily Step Count | 551 steps |
95% CI: [-2997, 1626]
95% CI: [-4794, 115]
95% CI: [-3477, 890]
95% CI: [-2424, 2153]
Secondary
Change in Hemoglobin A1c
Percent (%)
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight- or glucose-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Hemoglobin A1c | 0.003 % (HbA1c unit) |
| Twice Daily Text Message | Change in Hemoglobin A1c | 0.00000002 % (HbA1c unit) |
| Fixed Step Count Goal | Change in Hemoglobin A1c | 0.00000003 % (HbA1c unit) |
| Ramped Step Count Goal | Change in Hemoglobin A1c | 0.002 % (HbA1c unit) |
| Loss Framed Incentive | Change in Hemoglobin A1c | 0.00001 % (HbA1c unit) |
| Gain Framed Incentive | Change in Hemoglobin A1c | 0.000004 % (HbA1c unit) |
| Daily Step Count Goal | Change in Hemoglobin A1c | 0.02 % (HbA1c unit) |
| Weekly Step Count Goal | Change in Hemoglobin A1c | 0.000000002 % (HbA1c unit) |
95% CI: [-3.9, 3.9]
95% CI: [-2.6, 2.6]
95% CI: [-0.02, 0.02]
95% CI: [-22.8, 22.8]
Secondary
Change in High-density Lipoprotein (HDL)
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in High-density Lipoprotein (HDL) | 0.0008 mg/dL |
| Twice Daily Text Message | Change in High-density Lipoprotein (HDL) | 0.002 mg/dL |
| Fixed Step Count Goal | Change in High-density Lipoprotein (HDL) | 0.002 mg/dL |
| Ramped Step Count Goal | Change in High-density Lipoprotein (HDL) | 0.001 mg/dL |
| Loss Framed Incentive | Change in High-density Lipoprotein (HDL) | 0.0005 mg/dL |
| Gain Framed Incentive | Change in High-density Lipoprotein (HDL) | 0.004 mg/dL |
| Daily Step Count Goal | Change in High-density Lipoprotein (HDL) | 0.002 mg/dL |
| Weekly Step Count Goal | Change in High-density Lipoprotein (HDL) | 0.001 mg/dL |
95% CI: [-3.1, 3.1]
95% CI: [-2.3, 2.3]
95% CI: [-3.4, 3.4]
95% CI: [-0.5, 0.5]
Secondary
Change in Insulin
uIU/mL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=4 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Insulin | 0.00000002 uIU/mL |
| Twice Daily Text Message | Change in Insulin | 0.00003 uIU/mL |
| Fixed Step Count Goal | Change in Insulin | 0.0000006 uIU/mL |
| Ramped Step Count Goal | Change in Insulin | 0.000001 uIU/mL |
| Loss Framed Incentive | Change in Insulin | 0.005 uIU/mL |
| Gain Framed Incentive | Change in Insulin | 0.0000000001 uIU/mL |
| Daily Step Count Goal | Change in Insulin | 0.3 uIU/mL |
| Weekly Step Count Goal | Change in Insulin | 0.000000000002 uIU/mL |
95% CI: [-2311, 2311]
95% CI: [-27.9, 27.9]
95% CI: [-6.9, 6.8]
95% CI: [-126, 125]
Secondary
Change in Low-density Lipoprotein (LDL)
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Low-density Lipoprotein (LDL) | 0.1 mg/dL |
| Twice Daily Text Message | Change in Low-density Lipoprotein (LDL) | 0.2 mg/dL |
| Fixed Step Count Goal | Change in Low-density Lipoprotein (LDL) | 0.1 mg/dL |
| Ramped Step Count Goal | Change in Low-density Lipoprotein (LDL) | 0.2 mg/dL |
| Loss Framed Incentive | Change in Low-density Lipoprotein (LDL) | 0.005 mg/dL |
| Gain Framed Incentive | Change in Low-density Lipoprotein (LDL) | 5.7 mg/dL |
| Daily Step Count Goal | Change in Low-density Lipoprotein (LDL) | 5.4 mg/dL |
| Weekly Step Count Goal | Change in Low-density Lipoprotein (LDL) | 0.005 mg/dL |
95% CI: [-31.4, 31.5]
95% CI: [-44.3, 44.5]
95% CI: [-2.7, 14.2]
95% CI: [-13.3, 2.4]
Secondary
Change in Plasma Glucose
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1). Due to sample processing errors, n=2 additional results were missing.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Plasma Glucose | 0.006 mg/dL |
| Twice Daily Text Message | Change in Plasma Glucose | 0.000000004 mg/dL |
| Fixed Step Count Goal | Change in Plasma Glucose | 0.000002 mg/dL |
| Ramped Step Count Goal | Change in Plasma Glucose | 0.00001 mg/dL |
| Loss Framed Incentive | Change in Plasma Glucose | 0.000000002 mg/dL |
| Gain Framed Incentive | Change in Plasma Glucose | 0.01 mg/dL |
| Daily Step Count Goal | Change in Plasma Glucose | 0.00002 mg/dL |
| Weekly Step Count Goal | Change in Plasma Glucose | 0.000001 mg/dL |
95% CI: [-10.3, 10.3]
95% CI: [-0.03, 0.03]
95% CI: [-12.7, 12.7]
95% CI: [-0.03, 0.03]
Secondary
Change in Triglycerides
mg/dL; obtained fasting
Time frame: From baseline to follow-up in-person study visits, separated by 3 months
Population: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Once Daily Text Message | Change in Triglycerides | 0.03 mg/dL |
| Twice Daily Text Message | Change in Triglycerides | 0.00000005 mg/dL |
| Fixed Step Count Goal | Change in Triglycerides | 0.00001 mg/dL |
| Ramped Step Count Goal | Change in Triglycerides | 0.0001 mg/dL |
| Loss Framed Incentive | Change in Triglycerides | 0.0006 mg/dL |
| Gain Framed Incentive | Change in Triglycerides | 0.000002 mg/dL |
| Daily Step Count Goal | Change in Triglycerides | 0.0001 mg/dL |
| Weekly Step Count Goal | Change in Triglycerides | 0.00001 mg/dL |
95% CI: [-38.3, 38.2]
95% CI: [-0.3, 0.3]
95% CI: [-0.8, 0.8]
95% CI: [-0.4, 0.4]