Genetic Disorders of Obesity Program Database (GDOP)

This study collects data on children with severe, early-onset obesity.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood; Genetic Disease

Detailed Description

Children and adolescents who have suffered from severe weight gain prior to 5 years of age and who are seen in the Genetic Disorders of Obesity Program at Texas Children are asked to participate in a prospective, observational study. The investigators collect demographic information, body measurements, medical/family history, as well as other questionnaires. Additionally, genetic information, medical lab results, and responses to treatment options are collected. The goal of the study is to determine if the investigators can better understand which children would benefit from testing and further workup as well as to understand how obesity develops in these children and adolescents.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Stephanie Sisley, MD; Phone Number: 713-798-0391; Email: Sisley.lab@bcm.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Citrine Elatrash; Email: citrine.elatrash@bcm.edu
      • Principal Investigator: Stephanie Sisley, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children with early-onset, severe obesity.

Description

Inclusion Criteria:

• For individuals 2 years and older, BMI > 97 percentile
• For individuals < 2 years old, weight-to-length ratio > 95th percentile

Exclusion Criteria:

• No other exclusion criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of genetic causes of severe, early-onset obesity	We will measure the number of genetic variants identified in clinical testing	through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI over time	BMI in kg/m2 will be documented over time. BMI is calculated using weight and height	through participant completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Genetic Diseases, Inborn; Pediatric Obesity
• Other Study ID Numbers: H-44596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No