NCT02957916

Brief Summary

In order to better understand early onset obesity and to identify patients in interested in future research studies, including clinical trials, we aim to develop a registry for patients with early onset obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

13.1 years

First QC Date

October 31, 2016

Last Update Submit

February 19, 2026

Conditions

Childhood Onset ObesityPediatric ObesityChildhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Prevalence of genetic mutations in DNA analysis

    5 years

Eligibility Criteria

Age2 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children with a history of excessive weight gain.

You may qualify if:

  • BMI \>97th percentile for age and gender before 6 years old
  • Able to give written, informed consent/assent

You may not qualify if:

  • Diagnosis of Prader-Willi syndrome
  • Use of exogenous steroids or other medications known to cause abnormal weight gain
  • Cushing's syndrome, untreated growth hormone deficiency or untreated hypothyroidism as an etiology for the obesity
  • Hypothalamic obesity (obesity due to a brain tumor, head trauma or other brain lesion)
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA sample collected once in the form of either saliva or 5 mL of blood

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ashley Shoemaker, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSCI

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 8, 2016

Study Start

November 1, 2012

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data will be shared with collaborators and on a case by case basis. Please contact Dr. Shoemaker for information.

Locations

US(1)