NCT02360293

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
465

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2.6 years until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 6, 2020

Completed
Last Updated

January 6, 2020

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

January 14, 2015

Results QC Date

November 22, 2019

Last Update Submit

December 17, 2019

Conditions

Exercise

Keywords

ExerciseApp-mediatedVeterans

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device

    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

Secondary Outcomes (3)

  • Change in Weight as Measured From VA Medical Record

    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)

    Change from Baseline Depression score at one year after randomization

  • Change in Pain Measures as Assessed by the VA Pain Intensity

    Change from Baseline in Pain measures at one year after randomization

Study Arms (2)

Stay Strong w/coaching

EXPERIMENTAL

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

Stay Strong

ACTIVE COMPARATOR

participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.

Behavioral: Stay Strong

Interventions

Stay Strong w/coachingBEHAVIORAL

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 w/coaching
Stay StrongBEHAVIORAL

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.

Stay Strong

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (4)

  • 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.

    PMID: 30694208RESULT

  • 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.

    PMID: 32913914DERIVED

  • 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.

    PMID: 32687474DERIVED

  • 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.

    PMID: 30681965DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Issue with device connectivity leading to missing data. PA is focused on proprietary measure of Active Minutes and any potential changes to how it is calculated by Fitbit are out of our control. Pain and Depression are self-reported measures.

Results Point of Contact

Title
Laura Damschroder
Organization
VA ORD
laura.damschroder@va.gov
734-845-3603

Study Officials

  • Laura J. Damschroder, MPH

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

February 10, 2015

Study Start

September 25, 2017

Primary Completion

May 31, 2019

Study Completion

September 30, 2019

Last Updated

January 6, 2020

Results First Posted

January 6, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)