N/A
N=76
Lifestyle Improvement for Teens With Bariatric Surgery
Obesity, Adolescent · Bariatric Surgery Candidate
Bottom Line
View on ClinicalTrials.gov: NCT05393570 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Health-related Quality of Life as Measured by the HRQOL-14 — -9 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Healthy Lifestyle Behavioral Intervention (MBS -supported intervention) (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Health-related Quality of Life as Measured by the HRQOL-14 |
-9 | — |
| PRIMARY Change in Blood Lipid Levels as Assessed by Lipid Panel |
-3.97; 4.36; -45.36; 0.82; -8.18 | — |
| PRIMARY Change in Blood Glucose Level |
-2.3 | — |
| PRIMARY Change in Diastolic Blood Pressure |
-5 | — |
| PRIMARY Change in Systolic Blood Pressure |
-3.81 | — |
| PRIMARY Change in HbA1c Levels |
-0.353 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05393570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.