Lifestyle Improvement for Teens With Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity, Adolescent; Bariatric Surgery Candidate
• Interventions: Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)

• Registration Number: NCT05393570
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The purpose of this study is to Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-07
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

• is not medically referred by a physician for bariatric surgery
• Refuses to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)	-

Primary Outcome Measures

Name	Time	Method
Change in Health-related quality of life as measured by the HRQOL-14	1 month Pre surgery and 6 months post surgery	This survey includes 3 modules (Healthy Days Core Module = 4 questions, Activity Limitations Module = 5 questions, and the Healthy Days Symptoms Module = 5 questions). This survey is not based on a summary score. Instead to evaluate the score unhealthy days are the estimated total number of days in a 30 day period where participants felt their physical or mental health was not good. Survey responses from question 2 and 3 in the Healthy Days Core Module are combined to get overall unhealthy days.
Change in Diastolic Blood Pressure	pre surgery, 3 months post surgery, 6 months post surgery
Change in Blood Lipid Levels as Assessed by Lipid Panel	Pre surgery, 3 months post surgery, 6 months post surgery
Change in Blood Glucose Level	pre surgery, 3 months post surgery, 6 months post surgery
Change in Systolic Blood Pressure	pre surgery, 3 months post surgery, 6 months post surgery
Change in Blood Insulin Levels	Pre surgery, 3 months post surgery, 6 months post surgery
Change in HbA1c levels	pre surgery, 3 months post surgery, 6 months post surgery

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States