Weight Regain Treatment Post-Bariatric Surgery

NCT04662801 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-11-13

Study results available
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Summary

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Conditions

  • Obesity, Overweight

Interventions

BEHAVIORAL

Behavioral Weight Loss (BWL)

All participants will receive twelve weeks of BWL treatment.

BEHAVIORAL

Early Responder: BWL continued

Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.

COMBINATION_PRODUCT

Early Non-responder: BWL continued with medication added

Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.

Sponsors & Collaborators

  • American Psychological Foundation

    collaborator OTHER
  • Yale University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2022-09-13
Completion
2022-09-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662801 on ClinicalTrials.gov