Cue-Reward Learning and Weight Gain in Youth

NCT ID: NCT03254576

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2023-12-27

Brief Summary

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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.

Detailed Description

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The primary aim of this project is to conduct an adequately powered study that compares children at low risk for obesity to children at high risk for obesity on their brain responses to food tastes during a pavlovian learning task. Seven assessment visits will be conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up. Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an fMRI scan. This program of research tests a novel hypothesis regarding overeating and the development of obesity in children, and could provide critical data on individual vulnerabilities to overeating for further research. Furthermore, this study could provide mechanisms for intervention with regards to cue-reward learning in children, to ultimately prevent obesity in youth.

Conditions

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Overweight Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children at high-risk for obesity

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

Functional MRI

Intervention Type OTHER

Children at low-risk for obesity

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

Functional MRI

Intervention Type OTHER

Interventions

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Functional MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Kerri Boutelle

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerri Boutelle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25582522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28572588 (View on PubMed)

Other Identifiers

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R01DK111106

Identifier Type: NIH

Identifier Source: secondary_id

View Link

161468

Identifier Type: -

Identifier Source: org_study_id

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