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Completed

NCT Number: NCT05393570

Lifestyle Improvement for Teens With Bariatric Surgery

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.

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Key information

Conditions

Obesity, Adolescent Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Pre-surgery, 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.

  2. Change in Blood Lipid Levels as Assessed by Lipid Panel

    Time frame: Pre surgery, 6 months post surgery

    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.

  3. Change in Blood Glucose Level

    Time frame: pre surgery, 6 months post surgery

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

  4. Change in Diastolic Blood Pressure

    Time frame: pre surgery, 6 months post surgery

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

  5. Change in Systolic Blood Pressure

    Time frame: pre surgery, 6 months post surgery

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

  6. Change in HbA1c Levels

    Time frame: pre surgery, 6 months post surgery

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LIFT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 26, 2022
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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