NCT01822067

Brief Summary

The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Aug 2012Dec 2026

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

13.8 years

First QC Date

February 26, 2013

Last Update Submit

October 15, 2025

Conditions

Brain Function

Outcome Measures

Primary Outcomes (1)

  • Brain Structure

    We will use high resolution volumetric magnetic resonance imaging (MRI) and Diffusion tensor imaging (DTI) to measure the brain structure of 2 week old infants

    Age 2 weeks

Secondary Outcomes (1)

  • Brain Function

    Age 2 weeks

Study Arms (2)

Normal weight- Non Maternal obesity

Full-term neonates at 2 weeks of age born to normal weight mothers

Obese- Obese Mothers

Full-term neonates at two weeks of age born of obese mothers

Eligibility Criteria

Age11 Days - 17 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)

You may qualify if:

  • the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days

You may not qualify if:

  • none specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72203, United States

Location

Study Officials

  • Xiawei Ou, PhD

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

April 2, 2013

Study Start

August 1, 2012

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

US(1)