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Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans

Not Applicable
Completed
Conditions
Exercise
Interventions
Behavioral: Stay Strong w/coaching
Behavioral: Stay Strong
Registration Number
NCT02360293
Lead Sponsor
VA Office of Research and Development
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
465
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Stay Strong w/coachingStay Strong w/coachingparticipants 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 StrongStay Strongparticipants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Primary Outcome Measures
NameTimeMethod
Change in Physical Activity (PA) as Measured by the Study-provided Monitoring DeviceChange 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 Outcome Measures
NameTimeMethod
Change in Weight as Measured From VA Medical RecordChange 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 IntensityChange 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

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

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Ann Arbor, Michigan, United States

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