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CompletedNCT03396653Updated Jun 12, 2024Results posted

Peer Support for Weight Loss Maintenance

An interventional study of Peer-delivered Weight Maintenance and Professionally-Delivered Weight Maintenance in Obesity, sponsored by University of Connecticut. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by University of Connecticut · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
849
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Obesity

Keywords

  • weight loss
  • weight maintenance
  • weight control
  • peer support
  • patient-provided care
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 849 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Connecticut is the lead sponsor of 135 studies on the registry; 18 are open to participants now.

Browse University of Connecticut studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
849 participants (actual)

Study arms

  • Active comparator
    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 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

  • Active comparator
    Professionally-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.

    Behavioral: Professionally-Delivered Weight Maintenance

Interventions

  • BehavioralPeer-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 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).

  • BehavioralProfessionally-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.

06

What researchers measure

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).

    Time frame: 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).

    Time frame: Baseline to 18-months

07

Results

Posted May 2, 2024

Participant flow

Phase I (Weight Loss): 16 Weeks
Participant flow — Phase I (Weight Loss): 16 Weeks
MilestonePhase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 Weeks
Started153134562
Completed1531340
Not completed00562
Phase II (Weight Maintenance): 18 Months
Participant flow — Phase II (Weight Maintenance): 18 Months
MilestonePhase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 Weeks
Started1531340
6 month assessment1451310
12 month assessment1391220
Completed1441230
Not completed9110

Outcome measures

PrimaryWeight 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).

Time frame:
Baseline to 18-months
Reported as:
Mean · kilograms
Weight Change (kg)
kilogramsPeer-Delivered Weight MaintenanceProfessionally-Delivered Weight Maintenance
Weight Change (kg)1.2 ± 7.02.5 ± 6.0
SecondaryBlood Pressure (mmHg)

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

Time frame:
Baseline to 18-months
Reported as:
Mean · mmHg
Blood Pressure (mmHg)
mmHgPeer-Delivered Weight MaintenanceProfessionally-Delivered Weight Maintenance
Systolic Blood Pressure2.5 ± 13.44.0 ± 14.2
Diastolic Blood Pressure3.3 ± 8.24.6 ± 9.4

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight Maintenance0/153 (0%)36/153 (23.5%)103/153 (67.3%)
Phase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight Maintenance0/134 (0%)22/134 (16.4%)89/134 (66.4%)
Phase I Only (Weight Loss Phase): 16 Weeks0/562 (0%)0/562 (0%)18/562 (3.2%)
Most frequent serious events
Most frequent serious events
EventPhase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 Weeks
OtherGeneral disorders19/15313/1340/562
Muscle or bone injury (e.g., broken bone, torn ligament, sprain)Injury, poisoning and procedural complications7/1538/1340/562
Stroke, ministroke (TIA), or other neurological problemsNervous system disorders5/1530/1340/562
Heart TroubleCardiac disorders0/1533/1340/562
Gall bladder attack or surgeryGastrointestinal disorders2/1530/1340/562
New diagnosis, started treatment, or hospitalized for depressionPsychiatric disorders1/1530/1340/562
Asthma attack: leading to hospitalization or visit to ER / urgent careRespiratory, thoracic and mediastinal disorders1/1530/1340/562
PregnancyPregnancy, puerperium and perinatal conditions1/1530/1340/562
FaintingNervous system disorders1/1530/1340/562
Most frequent other events
Showing 10 of 13
Most frequent other events
EventPhase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 Weeks
OtherGeneral disorders75/15368/1345/562
Muscle or bone injury (e.g., broken bone, torn ligament, sprain)Injury, poisoning and procedural complications39/15342/1349/562
Heart TroubleCardiac disorders10/15310/1341/562
Motor vehicle accidentInjury, poisoning and procedural complications11/1538/1341/562
FaintingNervous system disorders9/1533/1340/562
Weight loss medication (including herbal remedies)Surgical and medical procedures4/1533/1340/562
New diagnosis, started treatment or hospitalized for any other mental health problemPsychiatric disorders2/1533/1340/562
Stroke, ministroke (TIA), or other neurological problemsNervous system disorders3/1531/1340/562
New diagnosis, started treatment, or hospitalized for depressionPsychiatric disorders3/1532/1341/562
New diagnosis or hospitalization for diabetesMetabolism and nutrition disorders2/1532/1340/562

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
Mean52.6 ± 11.754.8 ± 11.748.9 ± 12.250.5 ± 12.3
Sex: Female, Male
Sex: Female, Male(Participants)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
Female129111464704
Male242398145
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
Hispanic or Latino131894125
Not Hispanic or Latino140116434690
Unknown or Not Reported003434
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
American Indian or Alaska Native0123
Asian651526
Native Hawaiian or Other Pacific Islander0101
Black or African American151987121
White125101395621
More than one race751628
Unknown or Not Reported024749
Region of Enrollment
Region of Enrollment(participants)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
United States153134562849
Weight (kg)
Weight (kg)(kilograms)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
Mean82.9 ± 15.385.4 ± 17.4—84.0 ± 16.3
Blood pressure (mmHg)
Blood pressure (mmHg)(mm Hg)Phase I: Weight Loss Phase and Phase II (RCT): Peer-Delivered Weight MaintenancePhase I: Weight Loss Phase and Phase II (RCT): Professionally-Delivered Weight MaintenancePhase I Only (Weight Loss Phase): 16 WeeksTotal
Systolic Blood Pressure118.6 ± 15.6118.4 ± 13.2—118.5 ± 14.5
Diastolic Blood Pressure76.4 ± 8.376.8 ± 9.3—76.6 ± 8.7
08

Study locations

2 sites
  • UConn's Weight Management Research Group
    Hartford, Connecticut 06103, United States
  • Institute for Collaboration on Health, Intervention and Policy
    Storrs, Connecticut 06269, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 31, 2022
  • Informed consent form · Mar 31, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03396653
Lead sponsor
University of Connecticut
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Stanford University, The Miriam Hospital
Responsible party
Tricia Leahey (Associate Professor, University of Connecticut) — Principal investigator
First posted
Jan 11, 2018
Start date
Feb 19, 2018
Primary completion
Mar 16, 2023
Completion
Mar 21, 2023
Results posted
May 2, 2024
Last update
Jun 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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