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

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.

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Behavioral: Stay Strong w/coaching; Behavioral: Stay Strong

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).

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Stay Strong; participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI

Publications and helpful links

General Publications

• Olsen MK, Stechuchak KM, Hung A, Oddone EZ, Damschroder LJ, Edelman D, Maciejewski ML. A data-driven examination of which patients follow trial protocol. Contemp Clin Trials Commun. 2020 Aug 13;19:100631. doi: 10.1016/j.conctc.2020.100631. eCollection 2020 Sep.
• 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 Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. JMIR Res Protoc. 2019 Jan 29;8(1):e12526. doi: 10.2196/12526.
• 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. J Med Internet Res. 2020 Aug 4;22(8):e19216. doi: 10.2196/19216.
• Buis LR, Dawood K, Kadri R, Dawood R, Richardson CR, Djuric Z, Sen A, Plegue M, Hutton D, Brody A, McNaughton CD, Brook RD, Levy P. Improving Blood Pressure Among African Americans With Hypertension Using a Mobile Health Approach (the MI-BP App): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e12601. doi: 10.2196/12601.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Veterans; App-mediated
• Other Study ID Numbers: CRE 12-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No