Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K07CA215937 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Immediate Fitbit Intervention | Experimental | 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. |
|
| Comparator: Delayed Fitbit Intervention | Active Comparator | Wait-listed; participants maintain their usual physical activity for 12-weeks; participants then crossover and receive the full 12-week Fitbit intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Accrual Goal | The number of months to accrue the study sample. Accrual is part of assessing feasibility. | up to 1-year |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
| Change in Fall Risk |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cindy K Blair, PhD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39671575 | Derived | Blair CK, Brown-Glaberman U, Walters ST, Pestak C, Boyce T, Barriga L, Burgess E, Tawfik B, Killough C, Kinney AY, Demark-Wahnefried W, Meisner AL, Wiggins CL, Pankratz VS, Davis S. A Remotely Delivered Light-Intensity Physical Activity Intervention for Older Cancer Survivors: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 13;13:e59504. doi: 10.2196/59504. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Accrual Goal | The number of months to accrue the study sample. Accrual is part of assessing feasibility. | Posted | Number | months | up to 1-year |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Systematic Assessment | The fall occurred among a participant in the waitlisted intervention during the delivery of the intervention (vs. the waitlisted period). |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cindy Blair | University of New Mexico | 5059257907 | CiBlair@salud.unm.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2023 | Oct 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2022 | Oct 10, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 24-weeks |
| 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 12-weeks |
| 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. | 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.
| 24-weeks |
| 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. | 12-weeks |
| 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. | 24-weeks |
| 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. | 12-weeks |
| 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. | 24-weeks |
| 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. | 12-weeks |
| 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. | 24-weeks |
| 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. | post-intervention (end of 12-week intervention) |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| 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. | 24-weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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. | Posted | Count of Participants | Participants | 24-weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 24-weeks |
|
|
|
| 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. | Posted | Number | adverse events | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | chair stands | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | steps per day | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 12-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 24-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 12-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 24-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 12-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 12-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | points | post-intervention (end of 12-week intervention) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | chair stands | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | steps per day | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes per day | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | points | 24-weeks |
|
|
|
| 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. | Posted | Number | adverse events | 24-weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 1 | 32 |
|
Not provided
Not provided