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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
VA Office of Research and Development

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).

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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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360293


Locations
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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
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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:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02360293    
Other Study ID Numbers: CRE 12-305
First Posted: February 10, 2015    Key Record Dates
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

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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