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Recruiting NCT05747976

Genetic Disorders of Obesity Program Database

Observational Obesity, Childhood Genetic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity, Childhood, Genetic Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Primary outcome measures

  • Prevalence of genetic causes of severe, early-onset obesity [Time frame: through study completion, an average of 10 years]
Secondary outcome measures (1)
  • Change in BMI over time [Time frame: through participant completion, an average of 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Baylor College of Medicine — Houston

Identifiers

NCT: NCT05747976 · H-44596

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗