NCT05747976

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2020Dec 2030

Study Start

First participant enrolled

August 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

10.3 years

First QC Date

November 11, 2022

Last Update Submit

April 17, 2025

Conditions

Obesity, ChildhoodGenetic Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in BMI over time

    through participant completion, an average of 2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children with early-onset, severe obesity.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityGenetic Diseases, Inborn

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Stephanie Sisley, MD

CONTACT

713-798-0391Sisley.lab@bcm.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 11, 2022

First Posted

February 28, 2023

Study Start

August 30, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)