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Completed

NCT Number: NCT03254576

Cue-Reward Learning and Weight Gain in Youth

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional MRI

Other

Primary outcomes

  1. Cue-reward learning

    Time frame: Baseline only

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

  2. Reward Sensitivity

    Time frame: Baseline only

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

  3. Weight gain

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

    Whether rate of cue reward and reward sensitivity predict weight gain

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Acronym: ChildLearn

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2017
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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