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

July 19, 2023 updated by: VA Office of Research and Development

Learn, Engage, Act, Process (LEAP) for Personalized Weight Management Support (QUE 15-286)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
        • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimated)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QUX 16-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Primary outcome is based on data aggregated to the facility level. Thus, this question is N/A.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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