Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05125822
Other study ID # PEDS-2021-30024
Secondary ID STUDY00014425
Status Recruiting
Phase N/A
First received
Last updated
Start date August 26, 2023
Est. completion date January 1, 2028

Study information

Verified date January 2023
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Justin Ryder, PhD
Phone 3148826838
Email jryder@luriechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date January 1, 2028
Est. primary completion date May 1, 2026
Accepts healthy volunteers No
Gender All
Age group 11 Years to 15 Years
Eligibility 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

Study Design


Intervention

Other:
Meal replacement and lifestyle modification
Meal replacement and lifestyle modification

Locations

Country Name City State
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 17 weeks.
Primary 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. 17 weeks.
Primary 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. 17 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity: a Randomized Controlled Trial N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT01977105 - Healthy Growth Abbreviated Pilot Study N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT01937481 - The Colorado LEAP Study: A Socioecological Approach to Obesity Prevention in Early Childhood N/A