NCT02825680

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable obesity

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

May 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
12 days until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

May 12, 2016

Results QC Date

September 16, 2020

Last Update Submit

July 19, 2023

Conditions

Keywords

Weight LossBody Weight MaintenanceQuality Improvement

Outcome Measures

Primary Outcomes (1)

  • Rate of MOVE! Visits Per 1000 Candidate Veterans

    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

Study Arms (2)

Enhanced NCP Support

ACTIVE COMPARATOR

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

LEAP Intervention

EXPERIMENTAL

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 SupportOther: LEAP

Interventions

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

Enhanced NCP SupportLEAP Intervention
LEAPOTHER

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.

LEAP Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Limitations and Caveats

This was a pragmatic trial. Our main outcome measure relied on administratively collected data. Additionally, the causal pathway that leads from LEAP coaching to reach outcomes is likely impacted by unmeasured influences.

Results Point of Contact

Title
Laura Damschroder
Organization
VA Center for Clinical Management Research

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
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

July 7, 2016

Study Start

October 1, 2016

Primary Completion

September 30, 2019

Study Completion

September 30, 2020

Last Updated

July 27, 2023

Results First Posted

October 12, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

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

Locations