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

• ClinicalTrials.gov Identifier: NCT02360293
• Recruitment Status: Completed
• First Posted: February 10, 2015
• Results First Posted: January 6, 2020
• Last Update Posted: January 6, 2020
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Exercise	Behavioral: Stay Strong w/coaching; Behavioral: Stay Strong	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 465 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
• Actual Study Start Date: September 25, 2017
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: September 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device [ Time Frame: 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 Outcome Measures :

1. Change in Weight as Measured From VA Medical Record [ Time Frame: 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.
2. Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8) [ Time Frame: 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
3. Change in Pain Measures as Assessed by the VA Pain Intensity [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Michigan

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Laura J. Damschroder, MPH; VA Ann Arbor Healthcare System, Ann Arbor, MI

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] October 18, 2018

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02360293
• Other Study ID Numbers: CRE 12-305
• First Posted: February 10, 2015
• Results First Posted: January 6, 2020
• Last Update Posted: January 6, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by VA Office of Research and Development:

Exercise; App-mediated; Veterans