Lifestyle Improvement for Teens With Bariatric Surgery

NCT05393570 | Completed Results

• 2 other identifiers: HSC-SPH-19-04061R21HD105129-01A1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Change in Health-related Quality of Life as Measured by the HRQOL-14

  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.

  Pre-surgery, 6 months post-surgery

• Change in Blood Lipid Levels as Assessed by Lipid Panel

  Cholesterol (mg/dL), HDL cholesterol (mg/dL), Triglycerides (mg/dL), LDL cholesterol (mg/dL), non-HDL cholesterol (mg/dL) change from pre-surgery to 6 months post-surgery.

  Pre surgery, 6 months post surgery

• Change in Blood Glucose Level

  Measure of Blood Glucose (mg/dL) change from pre-surgery to 6 months post-surgery.

  pre surgery, 6 months post surgery

• Change in Diastolic Blood Pressure

  Measure diastolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.

  pre surgery, 6 months post surgery

• Change in Systolic Blood Pressure

  Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.

  pre surgery, 6 months post surgery

• Change in HbA1c Levels

  Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.

  pre surgery, 6 months post surgery

Study Arms (1)

Treatment

EXPERIMENTAL

Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)

Interventions

Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI \>35 kg/m\^2 and at least one existing co-morbidity \[e.g. elevated blood pressure, hypercholesterolemia, etc.\] or a BMI\>40kg/m\^2).
• received psychological clearance for surgery

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sarah E. Messiah
• Organization: UTSW - O'Donnell School of Public Health

Sarah.Messiah@UTSouthwestern.edu

(972) 546-2919

Study Officials

• Sarah E Messiah, Ph.D., MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: March 7, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 15, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)