Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
NCT ID: NCT02360293
Last Updated: 2020-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
465 participants
INTERVENTIONAL
2017-09-25
2019-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
64 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Laura J. Damschroder, MPH
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
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VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRE 12-305
Identifier Type: -
Identifier Source: org_study_id
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