Bariatric Surgery Candidate Clinical Trial
— LIFTOfficial title:
Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
The purpose of this study is to Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria - Must meet National Institutes of Health criteria to qualify for MBS for adolescents (BMI >35 kg/m2 and at least one existing co-morbidity [e.g. elevated blood pressure, hypercholesterolemia, etc.] or a BMI>40kg/m2). - received psychological clearance for surgery Exclusion Criteria: - is not medically referred by a physician for bariatric surgery - Refuses to participate in the study |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 month Pre surgery and 6 months post surgery | |
Primary | Change in Blood Insulin Levels | Pre surgery, 3 months post surgery, 6 months post surgery | ||
Primary | Change in Blood Lipid Levels as Assessed by Lipid Panel | Pre surgery, 3 months post surgery, 6 months post surgery | ||
Primary | Change in Blood Glucose Level | pre surgery, 3 months post surgery, 6 months post surgery | ||
Primary | Change in Diastolic Blood Pressure | pre surgery, 3 months post surgery, 6 months post surgery | ||
Primary | Change in Systolic Blood Pressure | pre surgery, 3 months post surgery, 6 months post surgery | ||
Primary | Change in HbA1c levels | pre surgery, 3 months post surgery, 6 months post surgery |
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