ObesityNCT02825680

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

A study testing Enhanced NCP Support and LEAP in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Obesity
What is being tested?: Enhanced NCP Support and LEAP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2016to 30 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Obesity
Being tested: Enhanced NCP Support, LEAP
Keywords: Weight Loss, Body Weight Maintenance, Quality Improvement
Medical subject headings: Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enhanced NCP SupportOther
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
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.

Study groups in NCT02825680
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Enhanced NCP Support; Other: LEAP

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201630 Sep 2020

First posted7 Jul 2016 (estimated)
Study start1 Oct 2016
Primary completion30 Sep 2019
Study completion30 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02825680
Sponsor's protocol ID: QUX 16-004
Status last verified: Jul 2023
First submitted: 12 May 2016
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Primary outcome is based on data aggregated to the facility level. Thus, this question is N/A.

Publications

Damschroder LJ, Evans R, Kim HM, Sussman J, Freitag MB, Robinson CH, Burns JA, Yankey NR, Lowery JC. Effectiveness of a virtual quality improvement training program to improve reach of weight management programs within a large health system. Health Serv Res. 2024 Dec;59 Suppl 2(Suppl 2):e14344. doi: 10.1111/1475-6773.14344. Epub 2024 Jul 25.
PubMed 39054798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Learn, Engage, Act, Process (LEAP) for Personalized Weight Management Support (QUE 15-286)
ClinicalTrials.gov ID: NCT02825680
Acronym / sponsor ID: QUX 16-004
Conditions: Obesity
Keywords: Weight Loss, Body Weight Maintenance, Quality Improvement
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 Oct 2016 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 7 Jul 2016 (estimated)
Results: Posted 12 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Enhanced NCP Support	Active comparator	Other: Enhanced NCP SupportTeams 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.
LEAP Intervention	Experimental	Other: Enhanced NCP Support, Other: LEAPCohorts 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.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enhanced NCP SupportNCP 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	Enhanced NCP Support, LEAP Intervention
LEAPThe 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.	Other	LEAP Intervention

Primary outcome

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).

Results and safety

Results posted to the registry on 12 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced NCP Support	82	82
LEAP Intervention	55	39

Primary outcome: Rate of MOVE! Visits Per 1000 Candidate Veterans

Time frame: 6 months. Mean (95% Confidence Interval). Unit: Rate of MOVE! Visits per 1000 Candidate

Measure	Enhanced NCP Support n = 82	LEAP Intervention n = 55
Before LEAP	4.504 (4.267 to 4.742)	4.853 (4.555 to 5.150)
After LEAP	4.824 (4.414 to 5.233)	5.061 (4.677 to 5.445)

Enhanced NCP Support vs LEAP Intervention: p = .011, Mixed Models Analysis

Adverse events

Time frame: This study did not collect data about individual patients. The unit of randomization for this study was VA Medical Centers. Participants in this study were a team of healthcare providers from the group MOVE! weight management program at each participating VA Medical Center.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced NCP Support	0 of 0	0 of 0	0
LEAP Intervention	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39054798Damschroder LJ, Evans R, Kim HM, Sussman J, Freitag MB, Robinson CH, Burns JA, Yankey NR, Lowery JC. Effectiveness of a virtual quality improvement training program to improve reach of weight management programs within a large health system. Health Serv Res. 2024 Dec;59 Suppl 2(Suppl 2):e14344. doi: 10.1111/1475-6773.14344. Epub 2024 Jul 25.
Individual participant dataSharing planned: No. Primary outcome is based on data aggregated to the facility level. Thus, this question is N/A.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura J. Damschroder, MPH principal investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced NCP Support and LEAP in people with Obesity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of MOVE! Visits Per 1000 Candidate Veterans (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02825680, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.