NCT02636998

Brief Summary

This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 29, 2025

Status Verified

September 1, 2024

Enrollment Period

8.6 years

First QC Date

June 22, 2015

Last Update Submit

January 27, 2025

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (2)

  • Psychological assessments

    Standardized assessments

    9-10 years

  • Neurocognitive measures

    Brain Lab Recordings

    9-10 years

Study Arms (2)

Normal weight

BMI \<85th percentile

Obese

BMI \> 95th percentile

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preadolescents and their mothers

You may qualify if:

  • Normal weight (BMI: \<85th percentile) or obese (BMI: \>95th percentile)
  • Right hand dominance
  • Report eating breakfast at least 4 days/week
  • Able to hear at least 20 dB stimulus
  • Visual acuity must be at least 20/40
  • Arithmetic Computation Task
  • Biological mother available to attend the enrollment study visit

You may not qualify if:

  • Full Scale IQ \<80
  • Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples and salivary samples

Study Officials

  • Linda Larson-Prior, Ph.D

    Arkansas Children's Nutrition Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 22, 2015

First Posted

December 22, 2015

Study Start

June 1, 2015

Primary Completion

January 6, 2024

Study Completion

December 1, 2025

Last Updated

January 29, 2025

Record last verified: 2024-09

Locations

US(1)