Lifestyle Improvement for Teens With Bariatric Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Adolescent, Bariatric Surgery Candidate

Intervention / Treatment
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* Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in Blood Insulin Levels |  | Pre surgery, 3 months post surgery, 6 months post surgery | 
| Change in Blood Lipid Levels as Assessed by Lipid Panel |  | Pre surgery, 3 months post surgery, 6 months post surgery | 
| Change in Blood Glucose Level |  | pre surgery, 3 months post surgery, 6 months post surgery | 
| Change in Diastolic Blood Pressure |  | pre surgery, 3 months post surgery, 6 months post surgery | 
| Change in Systolic Blood Pressure |  | pre surgery, 3 months post surgery, 6 months post surgery | 
| Change in HbA1c levels |  | pre surgery, 3 months post surgery, 6 months post surgery |