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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05393570
Other study ID # HSC-SPH-19-0406
Secondary ID 1R21HD105129-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date March 7, 2022
Est. completion date July 1, 2024

Study information

Verified date November 2023
Source The University of Texas Health Science Center, Houston
Contact Sarah E Messiah, Ph.D., MPH
Phone (972) 546-2919
Email Sarah.E.Messiah@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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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