Lifestyle Improvement for Teens With Bariatric Surgery

NCT05393570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-08-03

Study results available
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Summary

This study aims to conduct a proof-of-concept study to assess the feasibility, acceptability, and effectiveness of a Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.

Conditions

  • Obesity, Adolescent
  • Bariatric Surgery Candidate

Interventions

BEHAVIORAL

Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)

After patient/parent consent is completed, participants will begin the pre-MBS intervention phase. A minimum of 6 1- hour sessions will occur pre-MBS, and 26 will occur post-MBS.Dr. Klement, MBS coordinator and a diabetes educator will manage session delivery to adolescents/parents. All content will follow the Diabetes Prevention Program (DPP)-adapted curriculum flow. After that the research assistant will perform outreach, reminder calls, and follow-up for missed appointments. Pre-and post-MBS intervention delivery (based on adapted curriculum/model) may consist of a combination of 1-on-1 and group sessions (in-person or virtually), and online support tools, dependent upon adolescent/parent qualitative feedback on delivery method preference.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Sarah E Messiah, Ph.D., MPH · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2024-09-01
Completion
2024-10-15

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 NCT05393570 on ClinicalTrials.gov