NCT03254576

Brief Summary

The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

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

December 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

7.1 years

First QC Date

August 16, 2017

Last Update Submit

January 25, 2024

Conditions

Keywords

OverweightObesityBody Mass IndexWeightBrain imagingChildLearning

Outcome Measures

Primary Outcomes (3)

  • Cue-reward learning

    Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children

    Baseline only

  • Reward Sensitivity

    Whether the BOLD response to food cue differs between high and low-risk children

    Baseline only

  • Weight gain

    Whether rate of cue reward and reward sensitivity predict weight gain

    Change from baseline at an average of 12 months and 24 months

Study Arms (2)

Children at high-risk for obesity

Healthy-weight children (5th-75thBMI%) with two overweight/obese parents (BMI\>25)

Other: Functional MRI

Children at low-risk for obesity

Healthy-weight children (5th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9)

Other: Functional MRI

Interventions

Children at high-risk for obesityChildren at low-risk for obesity

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy-weight children (5-75thBMI%) between the ages of 8 and 11 years old with either two over-weight parents (BMI\>25) or two healthy-weight parents (BMI = 18-24.9)

You may qualify if:

  • Healthy weight children between the ages of 8 and 11 Years
  • BMI 5-75th percentile
  • Child must be right-handed
  • Child must be willing to participate in an fMRI scan
  • Either two biological parents who are overweight/obese or no biological parents that are overweight/obese
  • One biological parent willing to bring child to assessment visits
  • Child and participating parent Fluent in English for speaking, reading, and writing
  • Child must like cheese pizza and chocolate milkshake

You may not qualify if:

  • Child overweight (BMI≥85th percentile)
  • Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which physician supervision of diet and exercise prescription are needed
  • Child who is taking medications that may impact brain responses (can take kids who are stable on meds)
  • Child with MRI contraindications (presence of metallic foreign object or device in body, piercings that cannot be removed, tattooed permanent makeup that contain metal, braces, head trauma, claustrophobia, use of Bigen permanent hair dye)
  • Child with an active eating disorder (reported on EDE interview) or with first degree relative with Anorexia Nervosa or Bulimia Nervosa
  • Cognitive impairment or disability determined through parent and child self-report measures, and parent reported child individual education plan
  • Vision problems uncorrectable with lenses
  • Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used in the study
  • Menarche in female participants at time of enrollment
  • Children scoring within the midpubertal range or higher based on the Pubertal Development Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

Related Publications (2)

  • Boutelle KN, Wierenga CE, Bischoff-Grethe A, Melrose AJ, Grenesko-Stevens E, Paulus MP, Kaye WH. Increased brain response to appetitive tastes in the insula and amygdala in obese compared with healthy weight children when sated. Int J Obes (Lond). 2015 Apr;39(4):620-8. doi: 10.1038/ijo.2014.206. Epub 2014 Dec 11.

    PMID: 25582522BACKGROUND
  • Mestre ZL, Bischoff-Grethe A, Eichen DM, Wierenga CE, Strong D, Boutelle KN. Hippocampal atrophy and altered brain responses to pleasant tastes among obese compared with healthy weight children. Int J Obes (Lond). 2017 Oct;41(10):1496-1502. doi: 10.1038/ijo.2017.130. Epub 2017 Jun 2.

    PMID: 28572588BACKGROUND

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kerri Boutelle, Ph.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2017

First Posted

August 18, 2017

Study Start

December 1, 2016

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations