Lifestyle Improvement for Teens With Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— LIFT  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Adolescent
• Pediatric Obesity

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