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Lifestyle Improvement for Teens With Bariatric Surgery (LIFT)

Primary Purpose

Obesity, Adolescent, Bariatric Surgery Candidate

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity, Adolescent

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.
Change in Blood Insulin Levels
Change in Blood Lipid Levels as Assessed by Lipid Panel
Change in Blood Glucose Level
Change in Diastolic Blood Pressure
Change in Systolic Blood Pressure
Change in HbA1c levels

Secondary Outcome Measures

Full Information

First Posted
May 16, 2022
Last Updated
October 25, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05393570
Brief Title
Lifestyle Improvement for Teens With Bariatric Surgery
Acronym
LIFT
Official Title
Partnering Lifestyle Intervention With Bariatric Surgery to Maximize Health Outcomes in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Adolescent, Bariatric Surgery Candidate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyle Behavioral Intervention (MBS -supported intervention)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Health-related quality of life as measured by the HRQOL-14
Description
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.
Time Frame
1 month Pre surgery and 6 months post surgery
Title
Change in Blood Insulin Levels
Time Frame
Pre surgery, 3 months post surgery, 6 months post surgery
Title
Change in Blood Lipid Levels as Assessed by Lipid Panel
Time Frame
Pre surgery, 3 months post surgery, 6 months post surgery
Title
Change in Blood Glucose Level
Time Frame
pre surgery, 3 months post surgery, 6 months post surgery
Title
Change in Diastolic Blood Pressure
Time Frame
pre surgery, 3 months post surgery, 6 months post surgery
Title
Change in Systolic Blood Pressure
Time Frame
pre surgery, 3 months post surgery, 6 months post surgery
Title
Change in HbA1c levels
Time Frame
pre surgery, 3 months post surgery, 6 months post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah E Messiah, Ph.D., MPH
Phone
(972) 546-2919
Email
Sarah.E.Messiah@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rashon Braxton
Phone
(972) 546-2920
Email
Rashon.M.Braxton@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah E Messiah, Ph.D., MPH
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Messiah, Ph.D., MPH
Phone
972-546-2919
Email
Sarah.E.Messiah@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Rashon Braxton
Phone
(972) 546-2920
Email
Rashon.M.Braxton@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Improvement for Teens With Bariatric Surgery

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