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CompletedNCT03254576ChildLearnUpdated Jan 29, 2024

Cue-Reward Learning and Weight Gain in Youth

An observational study in Overweight and Obesity, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by University of California, San Diego · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
147
Ages
8 Years to 11 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Overweight
  • Obesity

Keywords

  • Overweight
  • Obesity
  • Body Mass Index
  • Weight
  • Brain imaging
  • Child
  • Learning
03

Who can participate

Ages eligible
8 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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)

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
147 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherFunctional MRI
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline only

  2. Reward Sensitivity

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

    Time frame: Baseline only

  3. Weight gain

    Whether rate of cue reward and reward sensitivity predict weight gain

    Time frame: Change from baseline at an average of 12 months and 24 months

06

Study locations

1 site
  • UCSD Center for Healthy Eating and Activity Research (CHEAR)
    La Jolla, California 92093, United States
07

References and documents

Publications

  • 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. PubMed 25582522 ↗
  • 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. PubMed 28572588 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03254576
Lead sponsor
University of California, San Diego
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Responsible party
Kerri Boutelle (Professor, University of California, San Diego) — Principal investigator
First posted
Aug 18, 2017
Start date
Dec 2016
Primary completion
Dec 27, 2023
Completion
Dec 27, 2023
Last update
Jan 29, 2024

Study contacts

Kerri Boutelle, Ph.D.
principal investigator · UCSD

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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