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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360293
• Other study ID #: CRE 12-305
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Exercise

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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