Clinical trial NCT02825680: Learn, Engage, Act, Process (LEAP) for MOVE!
Official title: Learn, Engage, Act, Process (LEAP) for Personalized Weight Management Support (QUE 15-286)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Body Weight Maintenance
Quality Improvement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-07-07
Enrollment: 137
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of MOVE! Visits Per 1000 Candidate Veterans
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Laura J. Damschroder, MPH
role: PRINCIPAL_INVESTIGATOR
References: