Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
17 december 2019 bijgewerkt door: VA Office of Research and Development
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
465
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 64 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- OEF/OIF/OND Veteran
- Can identify a VA Medical Center and VA Health Care Provider responsible for his/her care in the system
- Interested in starting a physical activity program in the next 30 days
- Access to a computer with an internet connection and a working USB port.
- A smartphone running a compatible iOS or Android operating system.
- Younger than Age 65
Exclusion Criteria:
- 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).
- History of eating disorders or a BMI < 20
- Not competent to consent to a research study by self-reporting a legal guardian who makes medical decisions for the Veteran.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Actieve vergelijker: Stay Strong
participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
Tijdsspanne: Change from Baseline in objectively monitored physical activity at one year after randomization
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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.
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Change from Baseline in objectively monitored physical activity at one year after randomization
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Weight as Measured From VA Medical Record
Tijdsspanne: Change from Baseline in weight at one year after randomization
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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.
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Change from Baseline in weight at one year after randomization
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Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)
Tijdsspanne: Change from Baseline Depression score at one year after randomization
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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
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Change from Baseline Depression score at one year after randomization
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Change in Pain Measures as Assessed by the VA Pain Intensity
Tijdsspanne: Change from Baseline in Pain measures at one year after randomization
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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
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Change from Baseline in Pain measures at one year after randomization
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
25 september 2017
Primaire voltooiing (Werkelijk)
31 mei 2019
Studie voltooiing (Werkelijk)
30 september 2019
Studieregistratiedata
Eerst ingediend
14 januari 2015
Eerst ingediend dat voldeed aan de QC-criteria
4 februari 2015
Eerst geplaatst (Schatting)
10 februari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 januari 2020
Laatste update ingediend die voldeed aan QC-criteria
17 december 2019
Laatst geverifieerd
1 december 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- CRE 12-305
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .