Lifestyle Improvement for Teens With Bariatric Surgery
- Conditions
- Obesity, AdolescentBariatric Surgery Candidate
- Registration Number
- NCT05393570
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
- 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
- Primary Outcome Measures
Name Time Method Change in Health-related Quality of Life as Measured by the HRQOL-14 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 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 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 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 pre surgery, 6 months post surgery Measure systolic blood pressure (mmHg) change from pre-surgery to 6 months post-surgery.
Change in HbA1c Levels pre surgery, 6 months post surgery Measure HbA1c% (mmol/mol) levels in blood change from pre-surgery to 6 months post-surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston🇺🇸Houston, Texas, United States
