ClinicalTrials.gov
ClinicalTrials.gov Menu

Cue-Reward Learning and Weight Gain in Youth (Child Learn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03254576
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kerri Boutelle, University of California, San Diego

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.

Condition or disease Intervention/treatment
Overweight Obesity Other: Functional MRI

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.

Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : December 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort Intervention/treatment
Children at high-risk for obesity
Healthy-weight children (30th-75thBMI%) with two overweight/obese parents (BMI>25)
Other: Functional MRI
Children at low-risk for obesity
Healthy-weight children (30th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9)
Other: Functional MRI



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy-weight children (30-75thBMI%) 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)
Criteria

Inclusion Criteria:

  • Healthy weight children between the ages of 8 and 11 Years
  • BMI 30-75th 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
  • Stage 3 or greater on the Tanner developmental stages of puberty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254576


Contacts
Contact: Zoe L Mestre, MS 858-246-2887 chear@ucsd.edu
Contact: Kerri Boutelle, Ph.D. 858-534-8037 kboutelle@ucsd.edu

Locations
United States, California
UCSD Center for Healthy Eating and Activity Research (CHEAR) Recruiting
La Jolla, California, United States, 92093
Contact: Zoe Mestre, M.S.    858-246-2887    chear@ucsd.edu   
Principal Investigator: Kerri Boutelle, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kerri Boutelle, Ph.D. UCSD

Publications:
Responsible Party: Kerri Boutelle, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03254576     History of Changes
Other Study ID Numbers: 161468
R01DK111106 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kerri Boutelle, University of California, San Diego:
Overweight
Obesity
Body Mass Index
Weight
Brain imaging
Child
Learning

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms