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Learn, Engage, Act, Process (LEAP) for MOVE!

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ClinicalTrials.gov Identifier: NCT02825680
Recruitment Status : Completed
First Posted : July 7, 2016
Results First Posted : October 12, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The overall goal of this project is to test whether the Learn. Engage. Act. Process (LEAP) intervention helps teams within the Veterans Health Administration's (VHA) local MOVE! group weight management programs be more in line with guidance. Forty-eight sites will be randomized to the LEAP intervention, which is a virtually delivered program that relies on the Institute for Healthcare Improvement (IHI) Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool. The LEAP intervention will be compared to active support that is provided to all VA MOVE! programs by the National Center for Health Promotion and Disease Prevention (NCP). The investigators will compare whether participation in LEAP results in engaging more Veterans in the MOVE! weight management program compared to facilities not participating in LEAP. The investigators will also collect information to understand what components of LEAP worked best and how to scale up so more teams can participate in LEAP.

Condition or disease Intervention/treatment Phase
Obesity Other: Enhanced NCP Support Other: LEAP Not Applicable

Detailed Description:

The Veterans Affairs (VA) National Center for Health Promotion and Disease Prevention (NCP) first disseminated MOVE! weight management program guidance in 2006. Program guidance was updated in 2014, which is expected to increase engagement and improve outcomes. However, variation in local programs is high. The overall goal of this project is to test the Learn. Engage. Act. Process (LEAP) intervention to work with teams virtually, to build skills in implementing program improvements. Forty-eight sites will be randomized to the LEAP intervention using a stepped-wedge trial design. LEAP is a virtually delivered program that relies on the IHI Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool. The LEAP intervention will be compared to active support provided by NCP to all local VA MOVE! teams. The investigators will compare whether teams participating in LEAP have MOVE! programs that engage more Veterans compared to facilities not participating in LEAP. The investigators will also collect information to understand which components of LEAP worked best and how to scale up and implement LEAP more broadly. The project aims are:

Aim 1: To develop three core products to enhance NCP support to Veterans Affairs Medical Centers (VAMCs) and to pilot LEAP in three VAMCs.

H1: Dissemination of products to enhance NCP support will improve MOVE! outcomes.

Aim 2: To determine effectiveness of LEAP plus enhanced NCP support (LEAP+NCP) versus enhanced NCP support alone.

H2: VAMCs with LEAP+NCP will have better MOVE! group outcomes than VAMCs with enhanced NCP support alone.

Aim 3: To conduct formative and cost evaluations to refine design of LEAP and inform future scaling-up of LEAP.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Learn, Engage, Act, Process (LEAP) for Personalized Weight Management Support (QUE 15-286)
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2020

Arm Intervention/treatment
Active Comparator: Enhanced NCP Support
Teams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from NCP.
Other: Enhanced NCP Support
NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool

Experimental: LEAP Intervention
Cohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.
Other: Enhanced NCP Support
NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool

Other: LEAP
The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool.




Primary Outcome Measures :
  1. Rate of MOVE! Visits Per 1000 Candidate Veterans [ Time Frame: 6 months ]
    Rate is calculated as aggregate number of MOVE! group visits per facility divided by aggregate count of candidate Veterans living w/in 40 miles multiplied by 1000. This will include facility level aggregated number of MOVE! group visits at rolling prospective 6 month time periods after the end of each stepped-wedge cohort timeframe. Time periods are rolling based on stepped-wedge trial design. Data will be extracted from the Corporate Data Warehouse (CDW).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unit of randomization is facility.
  • MOVE! group program in a VA Medical Center.
  • MOVE! coordinators at medical centers who express interest in participating in the trial prior to the first cohort randomization.

Exclusion Criteria:

  • Unit of randomization is facility.
  • Facilities that are not a medical center e.g., community-based outpatient clinic, Veteran service center

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): NCT02825680


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:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02825680    
Other Study ID Numbers: QUX 16-004
First Posted: July 7, 2016    Key Record Dates
Results First Posted: October 12, 2020
Last Update Posted: November 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Primary outcome is based on data aggregated to the facility level. Thus, this question is N/A.

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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:
Weight Loss
Body Weight Maintenance
Quality Improvement