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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced NCP Support

Other

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

LEAP

Other

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2020
First posted: Jul 7, 2016
Registry last updated: Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed