Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
17 dicembre 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
465
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Comparatore attivo: Stay Strong
participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
Lasso di tempo: 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 from Baseline in objectively monitored physical activity at one year after randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Weight as Measured From VA Medical Record
Lasso di tempo: 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.
|
Change from Baseline in weight at one year after randomization
|
|
Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)
Lasso di tempo: 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
|
Change from Baseline Depression score at one year after randomization
|
|
Change in Pain Measures as Assessed by the VA Pain Intensity
Lasso di tempo: 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
|
Change from Baseline in Pain measures at one year after randomization
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
25 settembre 2017
Completamento primario (Effettivo)
31 maggio 2019
Completamento dello studio (Effettivo)
30 settembre 2019
Date di iscrizione allo studio
Primo inviato
14 gennaio 2015
Primo inviato che soddisfa i criteri di controllo qualità
4 febbraio 2015
Primo Inserito (Stima)
10 febbraio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 gennaio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 dicembre 2019
Ultimo verificato
1 dicembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CRE 12-305
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Stay Strong w/coaching
-
Michigan State UniversityHenry Ford Health System; Butler Hospital; Pacific Institute for Research and EvaluationReclutamentoDepressione postpartoStati Uniti
-
Washington University School of MedicineRitiratoDepressione postpartoStati Uniti