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 : Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : December 6, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||455 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans|
|Actual Study Start Date :||September 25, 2017|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||September 30, 2019|
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.
- Change in Physical activity 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.
- Change in weight as measured with study-provided scale or from medical record (for missing values) [ Time Frame: Change from Baseline in weight at one year after randomization ]Weights will be objectively measured via a Bluetooth enabled scale.
- 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 PHQ will be administered via online survey.
- 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.
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
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Laura J. Damschroder, MPH||VA Ann Arbor Healthcare System, Ann Arbor, MI|