Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Adolescent
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Change in Health-related Quality of Life as Measured by the HRQOL-14
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
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.
Investigators
Sarah E Messiah
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •is not medically referred by a physician for bariatric surgery
- •Refuses to participate in the study
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.