Cancer Survivors
Conditions
Keywords
cancer survivor, physical activity, sedentary behavior, cancer survivorship, rural, older, Hispanic, physical function, physical performance, quality of life, home-based, distance-based
Brief summary
The Move for Your Health (MY Health) Pilot Study is a 12-week study for older cancer survivors to promote light physical activity. The home-based study (no travel required) will test whether a Fitbit activity tracker and health coaching can help cancer survivors be more active throughout the day.
Detailed description
The objective is to examine the feasibility and acceptability of a home-based lifestyle activity intervention to promote light-intensity activity using a whole-of-day approach. Sixty-four older cancer survivors will be randomized to either a 12-week theory-based intervention or a waitlist control. The intervention uses a Fitbit activity tracker that pairs with a smartphone app to promote awareness and enable self-monitoring of both activity and inactivity. Motivational counseling will be used to individually tailor strategies to achieve goals. Data will be collected at baseline, post-intervention (week 13), and 3-months post-intervention (week 26).
Interventions
BEHAVIORALFitbit Intervention
Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks.
Sponsors
National Cancer Institute (NCI)
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed in New Mexico (NM) with a loco-regionally staged cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence. Patients with metastatic cancer are eligible with physician approval. * Mild-to-moderate physical functional impairment (raw score between 20 and 34 on the 8-item PROMIS Physical Function survey) * Able to speak, read, & understand English or Spanish * Participating in less than 120 minutes per week of moderate-intensity physical activity * Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker) and without stopping to rest * Own a smartphone or tablet \*OR\* be willing to use a study-provided smartphone capable of running the Fitbit app. Also, access to the internet or a Wi-Fi hotspot at least once per week is required. Smartphones and data plans will be provided to those individuals who are eligible but do not currently own a device capable of running the Fitbit app. * Availability of a family member or friend to be present (for safety) during the remote assessment of physical performance tests * Willingness to be randomized to either study arm and to wear activity trackers
Exclusion criteria
* Adults not able to consent * Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily light physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, dementia, oxygen dependent, chronic vertigo) * Paid employment or volunteer position for greater than 20 hours per week (to avoid potential confounding by occupation activity/inactivity) * Currently participating in a program (personal program, e.g., wearing an activity monitor, or structured program, e.g., another study) to decrease sedentary time or increase physical activity * Planning to move out of New Mexico within the next year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Accrual Goal | up to 1-year | The number of months to accrue the study sample. Accrual is part of assessing feasibility. |
| Study Participant Retention Rate | 24-weeks | The proportion of participants who complete the study out of the number randomized to one of two study arms. Retention is part of assessing feasibility. |
| Study Participant Adherence Rate | 24-weeks | The proportion of participants who complete all five health coaching calls and wear the Fitbit activity tracker at least 67 days (67 days = 80% x 12 weeks). Adherence is part of assessing feasibility. |
| Number of Adverse Events Attributable to the Study | 12-weeks | The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility. |
| Change in Self-reported Physical Function | 12-weeks | Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Measures of Moderate-intensity Physical Activity | 12-weeks | The activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute. |
| Change in Objective Measures of Sedentary Activity | 12-weeks | The activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn. |
| Change in Self-reported Fatigue | 12-weeks | Self-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue. |
| Change in Self-reported Pain | 12-weeks | Self-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain. |
| Change in Self-reported Depression | 12-weeks | Self-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression. |
| Change in Self-reported Sleep Impairment | 12-weeks | Self-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment. |
| Change in Self-reported Social Participation | 12-weeks | Self-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation. |
| Change in Self-reported Anxiety | 12-weeks | Self-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety. |
| Change in Self-reported Sleep Disturbance | 12-weeks | Self-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance. |
| Change in the Number of Chair Stands During the 30-second Chair Stand Test | 12-weeks | Physical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength. |
| Change in Balance Score During the 4-stage Balance Test. | 12-weeks | Physical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance. |
| Change in Number of Steps Per Day | 12-weeks | The activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn. |
| Change in Objective Measures of Light-intensity Physical Activity | 12-weeks | The activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Objective Measures of Sedentary Activity | 24-weeks | The activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn. |
| Change in Self-reported Depression | 24-weeks | Self-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression. |
| Change in Self-reported Fatigue | 24-weeks | Self-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue. |
| Change in Fall Risk | 12-weeks | Risk for falls will be assessed by the Falls Efficacy Scale International. Scores range from 16 to 64, with higher scores representing greater concern about falling. |
| Change in Social Support for Physical Activity | 12-weeks | 4 items using a 5-point scale to measure support from family and friends while making changes to physical activity. Response items include never, once, sometimes, almost every day, and every day. Total scores range from 0 to 16; higher scores are indicative of greater social support for physical activity. |
| Change in Outcome Expectations | 12-weeks | Multidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active. Response items include strongly disagree, disagree, neutral, agree, and strongly agree. Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise. |
| Change in Motivation | 12-weeks | Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales. Subscales are weighted; RAI provides the degree to which a participant feels self-determined. Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation. |
| Perceived Autonomy Support | post-intervention (end of 12-week intervention) | Perceived Autonomy Support - Sport Climate Questionnaire (short form) includes 15 items to assess autonomy support of the health coach to characterize the quality of the social environment for influencing motivation to exercise. Mean individual scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach. Total score ranges from 7 (low autonomy) to 105 (high autonomy). Measured after the intervention for both groups; note: this survey was not administered prior to the intervention. |
| Change in Self-reported Physical Function | 24-weeks | Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning. |
| Change in Self-reported Pain | 24-weeks | Self-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain. |
| Change in the Number of Chair Stands During the 30-second Chair Stand Test | 24-weeks | Physical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength. |
| Change in Balance Score During the 4-stage Balance Test. | 24-weeks | Physical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance. |
| Change in Number of Steps Per Day | 24-weeks | The activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn. |
| Change in Objective Measures of Light-intensity Physical Activity | 24-weeks | The activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute. |
| Change in Objective Measures of Moderate-intensity Physical Activity | 24-weeks | The activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute. |
| Change in Self-reported Sleep Disturbance | 24-weeks | Self-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance. |
| Change in Self-reported Sleep Impairment | 24-weeks | Self-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment. |
| Change in Self-reported Social Participation | 24-weeks | Self-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation. |
| Change in Self-reported Anxiety | 24-weeks | Self-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Immediate Fitbit Intervention Participants randomized to this arm receive the 12-week Fitbit intervention; participants then crossover and are observed (no health coaching) for an additional 12-weeks. The Fitbit intervention includes a Fitbit activity tracker, the free Fitbit smartphone app, and 6 Health Coaching calls.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks. | 32 |
| Comparator: Delayed Fitbit Intervention Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention.
Fitbit Intervention: Participants receive a Fitbit activity tracker and the free Fitbit smartphone app. A trained health coach provides technical support to set up and use the Fitbit and app. The health coach also provides motivational counseling to help participants to gradually increase the number of steps per day during the 12-weeks. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Health event | 3 | 2 |
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Experimental: Immediate Fitbit Intervention | Comparator: Delayed Fitbit Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 32 Participants | 64 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.6 years STANDARD_DEVIATION 6.4 | 72.0 years STANDARD_DEVIATION 5 | 72.8 years STANDARD_DEVIATION 5.7 |
| Race/Ethnicity, Customized Race-ethnicity Hispanic | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Race-ethnicity non-Hispanic White | 20 Participants | 20 Participants | 40 Participants |
| Race/Ethnicity, Customized Race-ethnicity Other | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 24 Participants | 22 Participants | 46 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Change in Self-reported Physical Function
Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Physical Function | 0.03 points | Standard Deviation 4.25 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Physical Function | 1.22 points | Standard Deviation 3.77 |
Primary
Number of Adverse Events Attributable to the Study
The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Time frame: 24-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Number of Adverse Events Attributable to the Study | 0 adverse events |
| Comparator: Delayed Fitbit Intervention | Number of Adverse Events Attributable to the Study | 1 adverse events |
Primary
Number of Adverse Events Attributable to the Study
The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Time frame: 12-weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Number of Adverse Events Attributable to the Study | 0 adverse events |
| Comparator: Delayed Fitbit Intervention | Number of Adverse Events Attributable to the Study | 0 adverse events |
Primary
Study Participant Adherence Rate
The proportion of participants who complete all five health coaching calls and wear the Fitbit activity tracker at least 67 days (67 days = 80% x 12 weeks). Adherence is part of assessing feasibility.
Time frame: 24-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Study Participant Adherence Rate | 29 Participants |
| Comparator: Delayed Fitbit Intervention | Study Participant Adherence Rate | 26 Participants |
Primary
Study Participant Retention Rate
The proportion of participants who complete the study out of the number randomized to one of two study arms. Retention is part of assessing feasibility.
Time frame: 24-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Study Participant Retention Rate | 27 Participants |
| Comparator: Delayed Fitbit Intervention | Study Participant Retention Rate | 26 Participants |
Primary
Time to Accrual Goal
The number of months to accrue the study sample. Accrual is part of assessing feasibility.
Time frame: up to 1-year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Time to Accrual Goal | 9 months |
| Comparator: Delayed Fitbit Intervention | Time to Accrual Goal | 9 months |
Secondary
Change in Balance Score During the 4-stage Balance Test.
Physical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Balance Score During the 4-stage Balance Test. | 0.0 points | Standard Deviation 0.5 |
| Comparator: Delayed Fitbit Intervention | Change in Balance Score During the 4-stage Balance Test. | 0.1 points | Standard Deviation 0.5 |
Secondary
Change in Number of Steps Per Day
The activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Number of Steps Per Day | 1168 steps per day | Standard Deviation 2285 |
| Comparator: Delayed Fitbit Intervention | Change in Number of Steps Per Day | 69 steps per day | Standard Deviation 1495 |
Secondary
Change in Objective Measures of Light-intensity Physical Activity
The activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Light-intensity Physical Activity | 16.4 minutes per day | Standard Deviation 30.7 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Light-intensity Physical Activity | 0.0 minutes per day | Standard Deviation 14.5 |
Secondary
Change in Objective Measures of Moderate-intensity Physical Activity
The activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Moderate-intensity Physical Activity | 8.7 minutes per day | Standard Deviation 17.4 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Moderate-intensity Physical Activity | -1.1 minutes per day | Standard Deviation 7 |
Secondary
Change in Objective Measures of Sedentary Activity
The activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Sedentary Activity | -24.6 minutes per day | Standard Deviation 83.1 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Sedentary Activity | 2.9 minutes per day | Standard Deviation 57.4 |
Secondary
Change in Self-reported Anxiety
Self-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Anxiety | 0.91 points | Standard Deviation 3.11 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Anxiety | -0.25 points | Standard Deviation 4.47 |
Secondary
Change in Self-reported Depression
Self-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Depression | 1.28 points | Standard Deviation 4.17 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Depression | 0.03 points | Standard Deviation 3.11 |
Secondary
Change in Self-reported Fatigue
Self-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Fatigue | -1.38 points | Standard Deviation 5.76 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Fatigue | 1.09 points | Standard Deviation 3.79 |
Secondary
Change in Self-reported Pain
Self-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Pain | 1.38 points | Standard Deviation 7.38 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Pain | -0.56 points | Standard Deviation 4.28 |
Secondary
Change in Self-reported Sleep Disturbance
Self-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Sleep Disturbance | -0.78 points | Standard Deviation 5.74 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Sleep Disturbance | 0.50 points | Standard Deviation 4.59 |
Secondary
Change in Self-reported Sleep Impairment
Self-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Sleep Impairment | 0.81 points | Standard Deviation 2.98 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Sleep Impairment | 0.28 points | Standard Deviation 4.88 |
Secondary
Change in Self-reported Social Participation
Self-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Social Participation | 1.22 points | Standard Deviation 6.93 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Social Participation | 0.06 points | Standard Deviation 5.78 |
Secondary
Change in the Number of Chair Stands During the 30-second Chair Stand Test
Physical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength.
Time frame: 12-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in the Number of Chair Stands During the 30-second Chair Stand Test | 1.0 chair stands |
| Comparator: Delayed Fitbit Intervention | Change in the Number of Chair Stands During the 30-second Chair Stand Test | 0.5 chair stands |
Other Pre-specified
Change in Balance Score During the 4-stage Balance Test.
Physical performance will be objectively measured using the 4-stage balance test. The 4-stage balance test includes standing in each of four positions for up to 10 seconds: 1) feet side-by-side; 2) semi-tandem stand \[one foot slightly behind but touching the other foot\]; 3) tandem stand \[one foot in front of the other; heel touching toe\]; and 4) stand on one foot. Scores range from zero (participant refused, failed, or excluded from side-by-side test) to 5 (all four positions held for maximum time). Higher scores represent better balance.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Balance Score During the 4-stage Balance Test. | 0.1 points | Standard Deviation 0.5 |
| Comparator: Delayed Fitbit Intervention | Change in Balance Score During the 4-stage Balance Test. | 0.0 points | Standard Deviation 0.6 |
Other Pre-specified
Change in Fall Risk
Risk for falls will be assessed by the Falls Efficacy Scale International. Scores range from 16 to 64, with higher scores representing greater concern about falling.
Time frame: 12-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Fall Risk | 0.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Fall Risk | 0.0 points |
Other Pre-specified
Change in Fall Risk
Risk for falls will be assessed by the Falls Efficacy Scale International. Scores range from 16 to 64, with higher scores representing greater concern about falling.
Time frame: 24-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Fall Risk | 0.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Fall Risk | 0.0 points |
Other Pre-specified
Change in Motivation
Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales. Subscales are weighted; RAI provides the degree to which a participant feels self-determined. Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
Time frame: 12-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Motivation | 1.1 points | Standard Deviation 4.2 |
| Comparator: Delayed Fitbit Intervention | Change in Motivation | -0.4 points | Standard Deviation 2.6 |
Other Pre-specified
Change in Motivation
Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Behavioral Regulations in Exercise Questionnaire (BREQ-2) is a 19-item survey to assess autonomous motivation for exercise on a continuum from amotivation to intrinsic motivation. Mean scores range from 0 (not true for me) to 4 (very true for me) regarding motivation for exercise. Change in BREQ2 Relative Autonomy Index (RAI) is a single score derived from subscales. Subscales are weighted; RAI provides the degree to which a participant feels self-determined. Higher, positive scores indicate greater relative autonomy; whereas lower negative scores indicate more controlled regulation.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Motivation | -1.2 points | Standard Deviation 4.3 |
| Comparator: Delayed Fitbit Intervention | Change in Motivation | 1.6 points | Standard Deviation 2.6 |
Other Pre-specified
Change in Number of Steps Per Day
The activPAL accelerometer/inclinometer will be used to measure steps per day. Participants will be asked to wear the monitor for 7-days. Average daily steps will be calculated as the total steps divided by the number of days the monitor was worn.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Number of Steps Per Day | 296 steps per day | Standard Deviation 1828 |
| Comparator: Delayed Fitbit Intervention | Change in Number of Steps Per Day | 542 steps per day | Standard Deviation 2699 |
Other Pre-specified
Change in Objective Measures of Light-intensity Physical Activity
The activPAL accelerometer/inclinometer will measure the daily minutes spent in light-intensity stepping. The average daily minutes of light-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Light-intensity stepping is defined as stepping at a cadence between 75 and 99 steps per minute.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Light-intensity Physical Activity | 6.3 minutes per day | Standard Deviation 24.4 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Light-intensity Physical Activity | 9.8 minutes per day | Standard Deviation 26.6 |
Other Pre-specified
Change in Objective Measures of Moderate-intensity Physical Activity
The activPAL accelerometer/inclinometer will measure the daily minutes spent in moderate-intensity stepping. The average daily minutes of moderate-intensity stepping will be the total minutes divided by the number of days the activPAL monitor was worn. Moderate-intensity stepping is defined as stepping at a cadence of at least 100 steps per minute.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Moderate-intensity Physical Activity | 3.3 minutes per day | Standard Deviation 11.6 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Moderate-intensity Physical Activity | 5.2 minutes per day | Standard Deviation 16.4 |
Other Pre-specified
Change in Objective Measures of Sedentary Activity
The activPAL accelerometer/inclinometer will measure minutes spent in sedentary activities (not including sleep). The average daily minutes of sedentary time will be the total minutes divided by the number of days the activPAL monitor was worn.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Objective Measures of Sedentary Activity | -10.1 minutes per day | Standard Deviation 66.5 |
| Comparator: Delayed Fitbit Intervention | Change in Objective Measures of Sedentary Activity | -4.4 minutes per day | Standard Deviation 58.1 |
Other Pre-specified
Change in Outcome Expectations
Multidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active. Response items include strongly disagree, disagree, neutral, agree, and strongly agree. Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
Time frame: 12-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Outcome Expectations | 0.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Outcome Expectations | -1.0 points |
Other Pre-specified
Change in Outcome Expectations
Multidimensional Outcome Expectations for Exercise Scale includes 15 items to assess physical, social, and self-evaluative beliefs about the consequences of being physically active. Response items include strongly disagree, disagree, neutral, agree, and strongly agree. Scores range from 15 to 75, with higher scores indicative of higher levels of outcome expectations for exercise.
Time frame: 24-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Outcome Expectations | -1.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Outcome Expectations | 0.0 points |
Other Pre-specified
Change in Self-reported Anxiety
Self-reported anxiety will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Anxiety - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater anxiety.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Anxiety | -0.75 points | Standard Deviation 3.1 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Anxiety | -0.47 points | Standard Deviation 3.93 |
Other Pre-specified
Change in Self-reported Depression
Self-reported depression will be assessed using the PROMIS® Item Bank v1.0 - Emotional Distress - Depression - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater depression.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Depression | -1.94 points | Standard Deviation 4.83 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Depression | 0.19 points | Standard Deviation 2.97 |
Other Pre-specified
Change in Self-reported Fatigue
Self-reported fatigue will be assessed using the PROMIS® Item Bank v1.0 - Fatigue - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse fatigue.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Fatigue | -0.31 points | Standard Deviation 4.2 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Fatigue | -2.97 points | Standard Deviation 6.31 |
Other Pre-specified
Change in Self-reported Pain
Self-reported pain will be assessed using the PROMIS® Item Bank v1.0 - Pain Interference - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of worse pain.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Pain | 0.41 points | Standard Deviation 6.63 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Pain | -0.91 points | Standard Deviation 5.01 |
Other Pre-specified
Change in Self-reported Physical Function
Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Physical Function | 1.31 points | Standard Deviation 3.93 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Physical Function | 0.22 points | Standard Deviation 3.89 |
Other Pre-specified
Change in Self-reported Sleep Disturbance
Self-reported sleep disturbance will be assessed using the PROMIS® Item Bank v1.0 - Sleep Disturbance - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of greater sleep disturbance.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Sleep Disturbance | -0.78 points | Standard Deviation 4.71 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Sleep Disturbance | -2.38 points | Standard Deviation 4.51 |
Other Pre-specified
Change in Self-reported Sleep Impairment
Self-reported sleep impairment will be assessed using the PROMIS® Item Bank v1.0 - Sleep-Related Impairment - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater sleep impairment.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Sleep Impairment | 0.22 points | Standard Deviation 3.89 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Sleep Impairment | -1.09 points | Standard Deviation 4 |
Other Pre-specified
Change in Self-reported Social Participation
Self-reported ability to participate in social roles and activities will be assessed using the PROMIS® Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 8a. Raw scores range from 8 to 40, with higher scores indicative of greater social participation.
Time frame: 24-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Self-reported Social Participation | -1.28 points | Standard Deviation 5.59 |
| Comparator: Delayed Fitbit Intervention | Change in Self-reported Social Participation | 1.00 points | Standard Deviation 5.31 |
Other Pre-specified
Change in Social Support for Physical Activity
4 items using a 5-point scale to measure support from family and friends while making changes to physical activity. Response items include never, once, sometimes, almost every day, and every day. Higher scores are indicative of greater social support for physical activity.
Time frame: 24-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Social Support for Physical Activity | 0.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Social Support for Physical Activity | 0.0 points |
Other Pre-specified
Change in Social Support for Physical Activity
4 items using a 5-point scale to measure support from family and friends while making changes to physical activity. Response items include never, once, sometimes, almost every day, and every day. Total scores range from 0 to 16; higher scores are indicative of greater social support for physical activity.
Time frame: 12-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in Social Support for Physical Activity | 0.0 points |
| Comparator: Delayed Fitbit Intervention | Change in Social Support for Physical Activity | 0.0 points |
Other Pre-specified
Change in the Number of Chair Stands During the 30-second Chair Stand Test
Physical performance will be objectively measured using the 30-second chair stand test, measured by the number of times a person comes to a full standing position from a chair in 30 seconds. Scores range from zero (cannot perform the test) to 30 or higher, with a higher number of chair stands representing stronger leg strength.
Time frame: 24-weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Change in the Number of Chair Stands During the 30-second Chair Stand Test | 0.0 chair stands |
| Comparator: Delayed Fitbit Intervention | Change in the Number of Chair Stands During the 30-second Chair Stand Test | 0.0 chair stands |
Other Pre-specified
Perceived Autonomy Support
Perceived Autonomy Support - Sport Climate Questionnaire (short form) includes 15 items to assess autonomy support of the health coach to characterize the quality of the social environment for influencing motivation to exercise. Mean individual scores range from 1 to 7, with higher scores indicating greater autonomy support from the health coach. Total score ranges from 7 (low autonomy) to 105 (high autonomy). Measured after the intervention for both groups; note: this survey was not administered prior to the intervention.
Time frame: post-intervention (end of 12-week intervention)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental: Immediate Fitbit Intervention | Perceived Autonomy Support | 101.5 points |
| Comparator: Delayed Fitbit Intervention | Perceived Autonomy Support | 99.0 points |