RECRUITING

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Quick Facts

Study Start:2023-08-26
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05125822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 11 to less than 16 years old
  2. * BMI \> 30 kg/m\^2 or 95th BMI percentile
  3. * Tanner stage 2, 3, or 4
  1. * Tanner stage 1 and 5
  2. * Prior bariatric surgery
  3. * 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)
  4. * Monogenic and hypothalamic obesity
  5. * Polycystic ovary syndrome (diagnosed by a physician)
  6. * Pregnancy or planned pregnancy
  7. * Current use of supplemental hormones
  8. * Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder
  9. * Type 1 or 2 diabetes
  10. * Treatment with growth hormones
  11. * Thyroid disease/problem
  12. * Has had cancer in the last 10 years

Contacts and Locations

Study Contact

Justin Ryder, PhD
CONTACT
3148826838
jryder@luriechildrens.org

Principal Investigator

Justin Ryder, PhD
PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago

Study Locations (Sites)

Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States

Collaborators and Investigators

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

  • Justin Ryder, PhD, PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-26
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2023-08-26
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Childhood Obesity