NCT03338634

Brief Summary

This is a single, un-replicated visit to the Children's Metabolic Kitchen and Eating Behavior Lab designed to gather data on children's responses to images used in MRI studies. Additionally, a demographic questionnaire for parents will be piloted.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 9, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

5.1 years

First QC Date

October 11, 2017

Last Update Submit

April 4, 2022

Conditions

Keywords

Portion Size EffectChildhood ObesityfMRI

Outcome Measures

Primary Outcomes (1)

  • Pilot Image Description by Children

    Once the child is comfortable in our lab and consent has been received, they will be shown a total of 150 - 200 pictures of foods and non-food objects (e.g. office supplies). They will also be shown control images that are blurred or scrambled versions of the test images. After each picture, children will be instructed answer questions about the image (ex. what is this image, how much do you like it, how large is it, etc.)

    baseline

Secondary Outcomes (5)

  • Anthropometric Measures:weight

    baseline

  • Anthropometric Measures:height

    baseline

  • Demographic Questionnaire

    baseline

  • Freddy Fullness Scale Rating

    baseline

  • CAMS anxiety scale Rating

    baseline

Other Outcomes (1)

  • Post-Scanning Questionnaire

    baseline

Study Arms (1)

Children 6 to 10

Children must be between the ages of 6-10 years-old at the time they participate. All children will be physically healthy and without diagnosed learning disorders. A parent or legal guardian must be able to accompany the child.

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Parents and their 6-10 year old children in Centre County, Pennsylvania and surrounding areas.

You may qualify if:

  • Child is 6 to 10 years old
  • Child is physically healthy and does not have a diagnosed learning disorder

You may not qualify if:

  • Child is \< 6 or \> 10 years old
  • Child is not physically healthy or has a diagnosed learning disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metabolic Kitchen and Children's Eating Behavior Lab

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

  • Burger KS, Stice E. Variability in reward responsivity and obesity: evidence from brain imaging studies. Curr Drug Abuse Rev. 2011 Sep;4(3):182-9. doi: 10.2174/1874473711104030182.

    PMID: 21999692BACKGROUND
  • Bruce AS, Martin LE, Savage CR. Neural correlates of pediatric obesity. Prev Med. 2011 Jun;52 Suppl 1:S29-35. doi: 10.1016/j.ypmed.2011.01.018. Epub 2011 Feb 1.

    PMID: 21291906BACKGROUND
  • De Silva A, Salem V, Matthews PM, Dhillo WS. The use of functional MRI to study appetite control in the CNS. Exp Diabetes Res. 2012;2012:764017. doi: 10.1155/2012/764017. Epub 2012 May 8.

    PMID: 22719753BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kathleen L Keller, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Nutritional Sciences and Food Science

Study Record Dates

First Submitted

October 11, 2017

First Posted

November 9, 2017

Study Start

October 9, 2017

Primary Completion

December 1, 2022

Study Completion

July 1, 2023

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

De-identified data will be shared with other investigators by special request made by email to the PI (Kathleen L. Keller klk37@psu.edu). For investigators who request use of the data, we will request acknowledgement of our research group and Penn State University in any public presentation of the results obtained from this study.

Locations