NCT03396653

Brief Summary

The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
849

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

December 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 2, 2024

Completed
Last Updated

June 12, 2024

Status Verified

May 1, 2024

Enrollment Period

5.1 years

First QC Date

December 29, 2017

Results QC Date

April 9, 2024

Last Update Submit

May 16, 2024

Conditions

Keywords

weight lossweight maintenanceweight controlpeer supportpatient-provided care

Outcome Measures

Primary Outcomes (1)

  • Weight Change (kg)

    Weight change (measured on a digital scale to the nearest 0.1-kilogram) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).

    Baseline to 18-months

Secondary Outcomes (1)

  • Blood Pressure (mmHg)

    Baseline to 18-months

Study Arms (2)

Peer-Delivered Weight Maintenance

ACTIVE COMPARATOR

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).

Behavioral: Peer-delivered Weight Maintenance

Professionally-Delivered Weight Maintenance

ACTIVE COMPARATOR

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.

Behavioral: Professionally-Delivered Weight Maintenance

Interventions

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).

Peer-Delivered Weight Maintenance

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.

Professionally-Delivered Weight Maintenance

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-75
  • Body Mass Index between 25-50
  • English Speaking

You may not qualify if:

  • Report being unable to walk 2 blocks without stopping
  • Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
  • Are pregnant or plan to become pregnant within 1 year
  • Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
  • Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
  • Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
  • Have no Internet access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UConn's Weight Management Research Group

Hartford, Connecticut, 06103, United States

Location

Institute for Collaboration on Health, Intervention and Policy

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

  • Leahey TM, Gorin AA, Huedo-Medina TB, Denmat Z, Field C, Gilder C, Wyckoff EP, O'Connor K, Hahn K, Jenkins K, Unick JL, Hand G, McManus-Shipp K, Calcaterra J, Falk G. Patient-Delivered Continuous Care for Weight Loss Maintenance: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):767-776. doi: 10.1001/jamainternmed.2025.1345.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Zeely Denmat
Organization
University of Connecticut

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 11, 2018

Study Start

February 19, 2018

Primary Completion

March 16, 2023

Study Completion

March 21, 2023

Last Updated

June 12, 2024

Results First Posted

May 2, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations