Exercise
Conditions
Keywords
Exercise, App-mediated, Veterans
Brief summary
This project is Project three of a four project Prevention Coaching Lab CREATE grant entitled Transforming Prevention into Action aimed at effectively engaging patients and their families to improve their health and medical care. This project will test the feasibility and effectiveness of the prevention focused, internet mediated healthy lifestyle Stay Strong program tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans.
Detailed description
Veterans from Afghanistan and Iraq (OEF/OIF/OND) are at high risk for becoming overweight and obese. However, existing VA programs are not designed for younger Veterans who are comfortable with technology-mediated interventions, may not yet have developed obesity-related illnesses, and contain a relatively high percentage of women compared to previous Veteran cohorts. Technology-mediated lifestyle interventions that include continuous, objective home monitoring of physical activity, automated internet mediated feedback, and e-coaching increase physical activity and improve weight loss in non-Veteran populations. When delivered on a large scale, such interventions represent low cost but effective alternatives to face-to-face lifestyle change interventions that can be implemented widely in the VA health care system. Thus, this project will test the feasibility and effectiveness of the prevention focused, internet-mediated healthy lifestyle physical activity program, Stay Strong w/coaching, tailored to the needs, preferences and demographics of OEF/OIF/OND Veterans. Specifically, Stay Strong w/coaching relies on use of a wearable device, the Fitbit Charge 2, and incorporates coaching support, tailored messages, and personalized physical activity goals. Stay Strong w/coaching will be compared to the use of the Fitbit Charge 2 with standard online support (Stay Strong).
Interventions
BEHAVIORALStay Strong w/coaching
Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
BEHAVIORALStay Strong
Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. OEF/OIF/OND Veteran 2. Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system 3. Interested in starting a physical activity program in the next 30 days 4. Access to a computer with an internet connection and a working USB port. 5. A smartphone running a compatible iOS or Android operating system. 6. Younger than Age 65
Exclusion criteria
1. Veteran self-reports that a health care provider has told the patient that it is currently unsafe to exercise in an unsupervised or unmonitored setting. (Can become eligible with written medical clearance). 2. History of eating disorders or a BMI \< 20 3. Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device | Change from Baseline in objectively monitored physical activity at one year after randomization | Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight as Measured From VA Medical Record | Change from Baseline in weight at one year after randomization | Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale. |
| Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) | Change from Baseline Depression score at one year after randomization | The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24 |
| Change in Pain Measures as Assessed by the VA Pain Intensity | Change from Baseline in Pain measures at one year after randomization | Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10 |
Countries
United States
Participant flow
Recruitment details
Letters were mailed to potential participants. They used the information in the recruitment letter to accessed an online portal and respond to screening question. If eligible, they completed the consent documentation, baseline questionnaire, downloaded and registered the Stay Strong App. Recruitment period was from 10/1/2017 - 4/30/2018.
Pre-assignment details
After consent and prior to randomization participants were to completed baseline survey, register app, and complete a baseline physical activity (PA) period for randomization. 56 participants were excluded due to failure to complete baseline survey or register app. 52 participants were excluded due to failure to provide baseline PA.
Participants by arm
| Arm | Count |
|---|---|
| Stay Strong w/Coaching Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program. | 178 |
| Stay Strong Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device. | 179 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded | 1 | 0 |
| Overall Study | Lost to Follow-up | 73 | 95 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Stay Strong | Total | Stay Strong w/Coaching |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 9 | 39.8 years STANDARD_DEVIATION 8.7 | 39.2 years STANDARD_DEVIATION 8.4 |
| Depression scale (PHQ-8), Median | 6 units on a scale | 6.5 units on a scale | 7 units on a scale |
| Fitbit-Captured Active Minutes/Week, Median | 190 Active minutes/week | 178 Active minutes/week | 165 Active minutes/week |
| Fitbit-captured steps/day, mean | 8163 Steps/day STANDARD_DEVIATION 3978 | 7867 Steps/day STANDARD_DEVIATION 3737 | 7571 Steps/day STANDARD_DEVIATION 3464 |
| Pain Intensity >=4 | 75 Participants | 155 Participants | 80 Participants |
| PHQ-8 - Clinically Significant Depression | 57 Participants | 118 Participants | 61 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 27 Participants | 47 Participants | 20 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 114 Participants | 231 Participants | 117 Participants |
| Race/Ethnicity, Customized Other | 38 Participants | 79 Participants | 41 Participants |
| Region of Enrollment United States | 179 Participants | 357 Participants | 178 Participants |
| Sex: Female, Male Female | 43 Participants | 90 Participants | 47 Participants |
| Sex: Female, Male Male | 136 Participants | 267 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 178 | 0 / 179 |
| other Total, other adverse events | 3 / 178 | 1 / 179 |
| serious Total, serious adverse events | 0 / 178 | 0 / 179 |
Outcome results
Primary
Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.
Time frame: Change from Baseline in objectively monitored physical activity at one year after randomization
Population: Population decreases with time, at 12-month follow-up: SS+coaching 68; SS 58.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Stay Strong w/Coaching | Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device | -67.1 Active minutes/week |
| Stay Strong | Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device | -69.0 Active minutes/week |
Comparison: Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.95% CI: [-119, 122.7]
Secondary
Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)
The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24
Time frame: Change from Baseline Depression score at one year after randomization
Population: Population decreases with time, at 12-month follow-up: SS+coaching 96; SS 81.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Stay Strong w/Coaching | Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) | -0.410 score on a scale |
| Stay Strong | Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) | 0.752 score on a scale |
Comparison: The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.95% CI: [-2.969, 0.646]
Secondary
Change in Pain Measures as Assessed by the VA Pain Intensity
Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10
Time frame: Change from Baseline in Pain measures at one year after randomization
Population: Population decreases with time, at 12-month follow-up: SS+coaching 101; SS 84.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Stay Strong w/Coaching | Change in Pain Measures as Assessed by the VA Pain Intensity | 0.212 units on a scale |
| Stay Strong | Change in Pain Measures as Assessed by the VA Pain Intensity | 0.557 units on a scale |
Comparison: The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.95% CI: [-1.044, 0.353]
Secondary
Change in Weight as Measured From VA Medical Record
Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale.
Time frame: Change from Baseline in weight at one year after randomization
Population: Due to missing data from study provided scale, EHR weight was pulled for all patients, however, roughly half of the population lacked EHR weights within the time-frame of the study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Stay Strong w/Coaching | Change in Weight as Measured From VA Medical Record | -0.121 weight by pounds |
| Stay Strong | Change in Weight as Measured From VA Medical Record | 4.902 weight by pounds |
Comparison: The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.95% CI: [-15.85, 5.81]