Exercise Clinical Trial
Official title:
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
Verified date | December 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 465 |
Est. completion date | September 30, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Buis LR, McCant FA, Gierisch JM, Bastian LA, Oddone EZ, Richardson CR, Kim HM, Evans R, Hooks G, Kadri R, White-Clark C, Damschroder LJ. Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanist — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Change from Baseline in objectively monitored physical activity at one year after randomization | |
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. | Change from Baseline in weight at one year after randomization | |
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 | Change from Baseline Depression score at one year after randomization | |
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 | Change from Baseline in Pain measures at one year after randomization |
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