NCT05393570

Lifestyle Improvement for Teens With Bariatric Surgery

Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This proof-of-concept study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a lifestyle behavioral intervention integrated with metabolic and bariatric surgery (MBS) for adolescents with severe obesity. Targeting youth aged 12-18, the intervention is designed to enhance pre- and post-operative outcomes by supporting sustained healthy behaviors among patients and their families. Guided by formative qualitative research (AIM 1), the team will adapt an evidence-based multimedia lifestyle program (AIM 2) to align with adolescent MBS patients' unique needs and preferences. The adapted intervention will then be pilot-tested (AIM 3) among adolescent patients at a large adolescent healthcare system, with participants followed up to 12 months post-surgery. The program includes online components delivered before and after surgery, with progress evaluated at multiple time points. In addition to anthropometric and cardiometabolic outcomes, the study will assess intervention engagement, satisfaction, and delivery fidelity using the RE-AIM framework. The overarching goal is to demonstrate that combining lifestyle support with MBS can improve adherence, reduce attrition, and enhance long-term health outcomes among adolescents with severe obesity.

Conditions

• Obesity, Adolescent
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-07
• Primary completion: 2024-09-01
• Completion: 2024-10-15
• First posted: 2022-05-26
• Last updated: 2025-08-03
• Results posted: 2025-08-03

Locations

1 site across 1 country: United States