Lifestyle Improvement for Teens With Bariatric Surgery (LIFT)

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Sarah E Messiah, Ph.D., MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HSC-SPH-19-0406; 1R21HD105129-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No