ObesityNCT03396653

Peer Support for Weight Loss Maintenance

A study testing Peer-delivered Weight Maintenance and Professionally-Delivered Weight Maintenance in people with Obesity, run by University of Connecticut at 2 sites 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

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Obesity
What is being tested?: Peer-delivered Weight Maintenance and Professionally-Delivered Weight Maintenance
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 849 participants
Where: 2 sitesUnited States
Study dates: 19 Feb 2018to 21 Mar 2023
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UConn's Weight Management Research Group
Hartford, Connecticut, 06103
Institute for Collaboration on Health, Intervention and Policy
Storrs, Connecticut, 06269

Other trials in United States

About this study

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

Conditions: Obesity
Being tested: Peer-delivered Weight Maintenance, Professionally-Delivered Weight Maintenance
Keywords: weight loss, weight maintenance, weight control, peer support, patient-provided care
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.

Peer-delivered Weight MaintenanceBehavioural
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).
Professionally-Delivered Weight MaintenanceBehavioural
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.

Study groups in NCT03396653
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Professionally-Delivered Weight Maintenance

What is being measured

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

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).
Measured: Baseline to 18-months

Secondary outcomes (1)

Blood Pressure (mmHg)
Blood pressure (mmHg) from Phase II Baseline (post-Phase I) to the end of the Phase II maintenance program (18 months).
Measured: Baseline to 18-months

Timeline

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

19 Feb 201821 Mar 2023

First posted11 Jan 2018
Study start19 Feb 2018
Primary completion16 Mar 2023
Study completion21 Mar 2023

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.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 849 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03396653
Sponsor's protocol ID: H17-099
Other IDs: 1R01DK111232-01A1
Status last verified: May 2024
First submitted: 29 Dec 2017
Last updated: 12 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40423949

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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peer Support for Weight Loss Maintenance
ClinicalTrials.gov ID: NCT03396653
Acronym / sponsor ID: H17-099
Conditions: Obesity
Keywords: weight loss, weight maintenance, weight control, peer support, patient-provided care
Study type: Interventional
Recruitment status: Completed
Enrolment: 849 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, The Miriam Hospital
Study start: 19 Feb 2018 (actual)
Primary completion: 16 Mar 2023 (actual)
Study completion: 21 Mar 2023 (actual)
First posted: 11 Jan 2018 (actual)
Results: Posted 2 May 2024

Clinical summary

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Peer-Delivered Weight Maintenance	Active comparator	Behavioral: Peer-delivered Weight MaintenanceContingent 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).
Professionally-Delivered Weight Maintenance	Active comparator	Behavioral: Professionally-Delivered Weight MaintenanceContingent 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

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
Peer-delivered Weight MaintenanceContingent 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).	Behavioural	Peer-Delivered Weight Maintenance
Professionally-Delivered Weight MaintenanceContingent 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.	Behavioural	Professionally-Delivered Weight Maintenance

Primary outcome

Weight Change (kg)
Time frame: Baseline to 18-months
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).

1 secondary outcome

Blood Pressure (mmHg)
Time frame: Baseline to 18-months

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance	153	153
Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance	134	134
Phase I Only (Weight Loss Phase): 16 Weeks	562	0

Primary outcome: Weight Change (kg)

Time frame: Baseline to 18-months. Mean (Standard Deviation). Unit: kilograms

Measure	Peer-Delivered Weight Maintenance n = 144	Professionally-Delivered Weight Maintenance n = 124
Value	1.2 (7.0)	2.5 (6.0)

Population analysed: The number of participants analyzed in this outcome measure reflects the number that completed this measure at the 18 month assessment (primary outcome assessment). All missing participant data indicates that the participant did not complete this assessment procedure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored for all participants enrolled in Phase I (including participants randomized to Phase II) from from the start of the program to the post-Phase I assessment (a total of 16 weeks). For participants randomized to Phase II, Adverse events data were additionally collected at the Phase II baseline, 6-month, 12-month, 18-month assessments, as well as the no-treatment follow up assessment at 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance	36 of 153 (23.5%)	103 of 153 (67.3%)	0 of 153
Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance	22 of 134 (16.4%)	89 of 134 (66.4%)	0 of 134
Phase I Only (Weight Loss Phase): 16 Weeks	0 of 562 (0%)	18 of 562 (3.2%)	0 of 562

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40423949Leahey 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.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Peer-delivered Weight Maintenance and Professionally-Delivered Weight Maintenance in people with Obesity, run by University of Connecticut at 2 sites 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 7 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 May 2024). 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?

Weight Change (kg) (time frame: Baseline to 18-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 NCT03396653, 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 12 Jun 2024.