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CRE 12-305 – HSR Study

 
CRE 12-305
Stay Strong: A physical activity program for Afghanistan and Iraq Veterans
Laura J. Damschroder, MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, MI
Funding Period: April 2015 - September 2019
BACKGROUND/RATIONALE:
Veterans from Afghanistan and Iraq (OEF/OIF) are at high risk for becoming overweight and obese; 86% were overweight or obese at their first visit to the VA as reported in one recent study. However, existing VA programs are not designed for younger Veterans who are more comfortable with technology-mediated interventions than older Veterans and who may not yet have developed obesity-related chronic diseases. Additionally, OEF/OIF Veterans include a relatively high percentage of women compared to previous Veteran cohorts. These differences should be addressed in lifestyle interventions customized to OEF/OIF Veterans.

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. The VA health care system is in a strong position to implement such interventions on a national scale because of existing structures such as a national electronic medical records system. Such interventions can be centrally administered and marketed directly to Veterans, capitalizing on economies of scale, expanding intervention reach, and reducing the burdening of recruitment on the existing health care team. However, with the exception of one pilot study, prevention focused technology-mediated physical activity programs that include continuous, objective home monitoring of physical activity, automated internet or cell-phone mediated feedback, and e-coaching have not been customized and tested for OEF/IOF Veterans.

OBJECTIVE(S):
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 Veterans. The specific aims of this project are to: 1) evaluate the impact of an automated, centrally administered, smartphone app-mediated, physical activity intervention, Stay Strong, on physical activity among OEF/OIF Veterans; 2) evaluate the impact of Stay Strong on the secondary outcomes of weight loss, depression and pain among OEF/OIF Veterans; and 3) test for moderation of the intervention effect of the Stay Strong intervention by gender with respect to the primary outcome of physical activity per day, as well as secondary outcomes of weight loss, depression and pain.

METHODS:
In this randomized controlled study, OEF/OIF Veterans randomly selected from clinical warehouse data (CDW) using a flag indicating OEF/OIF/OND status and younger than 65. Veterans will be randomized into either an active control arm (basic Stay Strong) or the Stay Strong app plus personalized exercise goals, tailored push notifications, and three phone-based health coaching calls in the first 6-8 weeks. Programs will last for one year for both arms. The primary outcome is change in physical activity per day averaged over 7 days. Weight loss, pain and depression are secondary outcomes. Because gender moderates the impact of physical activity interventions, we will and over-sample women. The trial is innovative in that study staff will have no face-to-face contact with participants. All participant recruitment, eligibility screening, informed consent, baseline assessment, randomization, intervention delivery and outcome assessment will be internet or smartphone app mediated. A constrained longitudinal data model in which baseline physical activity is modeled as a dependent variable in conjunction with the constraint of a common baseline mean across the treatment group will test for a between-group comparison in physical activity from baseline to 12 months in the intervention and control groups.

FINDINGS/RESULTS:
Recruitment on this project has begun however, no findings to date.

IMPACT:
If successful, the Stay Strong program could be implemented as a national program to augment the VA's current panel of options for OEF/OIF Veterans who need support to maintain a healthy lifestyle and prevent future disease. (March 2018)


External Links for this Project

NIH Reporter

Grant Number: I01HX001163-01
Link: https://reporter.nih.gov/project-details/8486713

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PUBLICATIONS:

Journal Articles

  1. Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemporary clinical trials communications. 2020 Sep 1; 19:100631. [view]
  2. Damschroder LJ, Buis LR, McCant FA, Kim HM, Evans R, Oddone EZ, Bastian LA, Hooks G, Kadri R, White-Clark C, Richardson CR, Gierisch JM. Effect of Adding Telephone-Based Brief Coaching to an mHealth App (Stay Strong) for Promoting Physical Activity Among Veterans: Randomized Controlled Trial. Journal of medical Internet research. 2020 Aug 4; 22(8):e19216. [view]


DRA: Health Systems
DRE: Prevention, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Adherence, Health Promotion and Education, Outcomes - Patient, Risk Factors, Symptom Management
MeSH Terms: none

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