LIFT: Lifestyle Improvement for Teens With Bariatric Surgery

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT05393570

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arm

19.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Adolescent Bariatric Surgery Candidate	Behavioral: Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment	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.

Arm

Intervention/Treatment

Experimental: Treatment

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.

Outcome Measures

Primary Outcome Measures

Change in Health-related quality of life as measured by the HRQOL-14 [1 month Pre surgery and 6 months post surgery]
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sarah E Messiah, Ph.D., MPH, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sarah E Messiah, Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT05393570

Other Study ID Numbers:

HSC-SPH-19-0406
1R21HD105129-01A1

First Posted:

May 26, 2022

Last Update Posted:

May 26, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pediatric Obesity

Study Results

No Results Posted as of May 26, 2022