Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity (ADMIRE)
Primary Purpose
Childhood Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal replacement and lifestyle modification
Sponsored by
About this trial
This is an interventional basic science trial for Childhood Obesity
Eligibility Criteria
Inclusion Criteria:
- 11 to less than 16 years old
- BMI > 30 kg/m^2 or 95th BMI percentile
- Tanner stage 2, 3, or 4
Exclusion Criteria:
- Tanner stage 1 and 5
- Prior bariatric surgery
- Current or recent (< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Monogenic and hypothalamic obesity
- Polycystic ovary syndrome (diagnosed by a physician)
- Pregnancy or planned pregnancy
- Current use of supplemental hormones
- Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
- Type 1 or 2 diabetes
- Treatment with growth hormones
- Thyroid disease/problem
- Has had cancer in the last 10 years
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meal Replacement and Lifestyle Therapy
Arm Description
Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.
Outcomes
Primary Outcome Measures
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)
We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.
Change in ghrelin
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.
Change in gastric inhibitory polypeptide
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.
Secondary Outcome Measures
Full Information
NCT ID
NCT05125822
First Posted
November 8, 2021
Last Updated
August 30, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05125822
Brief Title
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Acronym
ADMIRE
Official Title
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables.
Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.
Detailed Description
Individuals who are found to be eligible to participate will have two study interventions: An 8-week meal replacement therapy period in which they are asked to reduce their BMI by >5%. Participants will be asked to strictly follow the individually-prescribed eating regimen which will include meal replacement shakes and/or frozen meals to be used for breakfast and lunch. For dinner, the study will provide pre-packaged frozen entrée meals to be consumed with two servings of fruit and three servings of vegetables per day. Meal replacement compliance will be assessed by requiring participants to maintain a dietary log throughout the study. The percentage of days for which the protocol was followed (no additional calories consumed) will serve as the primary metric of compliance.
Participants will also receive a standardized lifestyle/behavioral modification counseling every 2 weeks throughout the entire study, which will be delivered at each in-person study visit and via virtual platform of phone when there is no in-person study visit scheduled. The lifestyle curriculum will incorporate evidence-based behavior change principles including dietary modification, energy expenditure modification, behavior modification and family involvement and support. To ensure fidelity and adherence to the delivery protocol, a manual will be developed for each session that trained staff will follow when administering the curriculum.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single group study that will consist of two interventions: an 8-week meal replacement therapy period in which participants are asked to reduce their body mass index (BMI) by >/= 5% by following a prescribed eating regimen and standardized lifestyle/behavior modification counseling which will occur every 2 weeks throughout the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meal Replacement and Lifestyle Therapy
Arm Type
Experimental
Arm Description
Participants in this study will have an 8-week meal replacement therapy period in which they are asked to reduce their BMI by 5% by following a prescribed eating regimen consisting of meal replacement shakes and/or frozen meals for breakfast and lunch. For dinner they will consume a pre-packaged frozen entree to be consumed with two servings of fruit and three servings of vegetables per day. Participants will also have lifestyle/behavioral modification counseling every 2 weeks throughout the entire study.
Intervention Type
Other
Intervention Name(s)
Meal replacement and lifestyle modification
Intervention Description
Meal replacement and lifestyle modification
Primary Outcome Measure Information:
Title
Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)
Description
We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.
Time Frame
17 weeks.
Title
Change in ghrelin
Description
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.
Time Frame
17 weeks.
Title
Change in gastric inhibitory polypeptide
Description
We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.
Time Frame
17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
11 to less than 16 years old
BMI > 30 kg/m^2 or 95th BMI percentile
Tanner stage 2, 3, or 4
Exclusion Criteria:
Tanner stage 1 and 5
Prior bariatric surgery
Current or recent (< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
Monogenic and hypothalamic obesity
Polycystic ovary syndrome (diagnosed by a physician)
Pregnancy or planned pregnancy
Current use of supplemental hormones
Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
Type 1 or 2 diabetes
Treatment with growth hormones
Thyroid disease/problem
Has had cancer in the last 10 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Ryder, PhD
Phone
3148826838
Email
jryder@luriechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ryder, PhD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin R Ryder
Phone
314-882-6838
Email
jryder@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Justin Ryder, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity
We'll reach out to this number within 24 hrs