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Childhood ObesityNCT03766191

Genetic Predisposition to Food Cue Reactivity in Children

A study testing Food Ads and Non-food Ads in people with Childhood Obesity, run by Trustees of Dartmouth College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
Food Ads and Non-food Ads
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
189 participants
Where
1 siteUnited States
Study dates
10 Jan 2019to 27 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • English fluency
  • Willingness to participate in all study visits

Who cannot join

  • Relevant food allergies or dietary restrictions
  • Metal in or on the body
  • Claustrophobia
  • Psychiatric and neurological disorders
  • Relative in the study
  • Appetite- or attention-altering medications or disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: The Relation of Genetic Factors, Food Cues, and Self-Regulation With Excess Consumption and Adiposity in Children

This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.

Read the detailed description

The investigators will assess the associations between genetic factors, food-cue-related neural reactivity, eating in the absence of hunger (EAH) in response to food cues, and adiposity gain in children. They will also determine whether self-regulatory capacity modifies these associations. The genetic factors explored specifically include FTO, MC4R, polymorphisms in genes involved in dopaminergic pathways, and a composite genetic risk score built from genome-wide obesity-related loci.

[3/14/2020]: Study recruitment temporarily halted due to the COVID-19 pandemic

Being tested
Food Ads, Non-food Ads
Keywords
Obesity, Cue Reactivity, Genetics, Self Regulation, fMRI, Children, Eating in the Absence of Hunger
Medical subject headings
Pediatric Obesity, Obesity, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food AdsBehavioural

    Exposure to foods ads embedded in an age-appropriate TV program

  • Non-food AdsOther

    Exposure to non-food ads embedded in an age-appropriate TV program

Study groups in NCT03766191
Study groupRoleWhat they receive
Food Ads and fMRIActive comparatorExposure to food ads during an fMRI scan
Receives: Behavioral: Food Ads
Non-Food Ads and fMRISham comparatorExposure to non-food ads during an fMRI scan
Receives: Other: Non-food Ads
Food Ads and TV showActive comparatorExposure to food ads embedded in an age-appropriate TV program
Receives: Behavioral: Food Ads
Non-Food Ads and TV showSham comparatorExposure to non-food ads embedded in an age-appropriate TV program
Receives: Other: Non-food Ads

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food-cue-related neural activity

    Activation in brain reward regions in response to food vs. non-food cues, as measured by differences in the blood-oxygen-level dependent response during fMRI scans. Investigators will examine associations between polymorphisms in FTO, MC4R, as well as a genetic risk score with the differential neural activity.

    Measured: Baseline

  2. Food-cue-related Eating in the Absence of Hunger (EAH)

    Difference in kcals consumed in response to food vs. non-food cue exposure in the behavioral sessions. Investigators will examine how differential neural activity in response to food vs. non-food cues will relate to EAH. Investigators will also assess whether self-regulatory capacity diminishes this association between differential neural activity and EAH.

    Measured: Baseline, 2 weeks, 4 weeks

  3. Change in BMI

    Difference between BMI z-score according to the Center for DiseaSe Control 2000 Growth Reference Curves assessed at baseline and follow-up. Investigators will assess the associations between genetic factors (polymorphisms in FTO, MC4R; and a genetic obesity risk score), food-cue-related neural activity and EAH with change in BMI.

    Measured: Baseline, 1-year followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2018
  2. Study start10 Jan 2019
  3. Primary completion27 Mar 2024
  4. Study completion27 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03766191
Sponsor's protocol ID
D19064
Other IDs
1R01HD092604
Status last verified
Nov 2024
First submitted
4 Dec 2018
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

    PubMed 24570244

  • Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.

    PubMed 15837955

  • Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. J Pediatr. 2007 Jan;150(1):12-17.e2. doi: 10.1016/j.jpeds.2006.08.042.

    PubMed 17188605

  • Dietz WH. Overweight in childhood and adolescence. N Engl J Med. 2004 Feb 26;350(9):855-7. doi: 10.1056/NEJMp048008. No abstract available.

    PubMed 14985480

  • Guo SS, Chumlea WC. Tracking of body mass index in children in relation to overweight in adulthood. Am J Clin Nutr. 1999 Jul;70(1):145S-148S. doi: 10.1093/ajcn/70.1.145s.

    PubMed 10393162

  • Guyenet SJ, Schwartz MW. Clinical review: Regulation of food intake, energy balance, and body fat mass: implications for the pathogenesis and treatment of obesity. J Clin Endocrinol Metab. 2012 Mar;97(3):745-55. doi: 10.1210/jc.2011-2525. Epub 2012 Jan 11.

    PubMed 22238401

  • Lutter M, Nestler EJ. Homeostatic and hedonic signals interact in the regulation of food intake. J Nutr. 2009 Mar;139(3):629-32. doi: 10.3945/jn.108.097618. Epub 2009 Jan 28.

    PubMed 19176746

  • Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.

    PubMed 26644270

  • Gilbert-Diamond D, Emond JA, Lansigan RK, Rapuano KM, Kelley WM, Heatherton TF, Sargent JD. Television food advertisement exposure and FTO rs9939609 genotype in relation to excess consumption in children. Int J Obes (Lond). 2017 Jan;41(1):23-29. doi: 10.1038/ijo.2016.163. Epub 2016 Sep 22.

    PubMed 27654143

  • Baumeister RF, Heatherton TF. Self-Regulation Failure: An Overview. Psychological Inquiry. 2009;7(1):1-15. doi:10.1207/s15327965pli0701_1.

  • Heatherton TF, Wagner DD. Cognitive neuroscience of self-regulation failure. Trends Cogn Sci. 2011 Mar;15(3):132-9. doi: 10.1016/j.tics.2010.12.005. Epub 2011 Jan 26.

    PubMed 21273114

  • Muraven M, Baumeister RF, Tice DM. Longitudinal improvement of self-regulation through practice: building self-control strength through repeated exercise. J Soc Psychol. 1999 Aug;139(4):446-57. doi: 10.1080/00224549909598404.

    PubMed 10457761

  • Gailliot MT, Plant EA, Butz DA, Baumeister RF. Increasing self-regulatory strength can reduce the depleting effect of suppressing stereotypes. Pers Soc Psychol Bull. 2007 Feb;33(2):281-94. doi: 10.1177/0146167206296101.

    PubMed 17259587

  • Costanzo PR, Woody EZ. Domain-specific parenting styles and their impact on the child's development of particular deviance: the example of obesity proneness. Journal of social and clinical psychology. 1985;3(4):425-445.

  • Fisher JO, Birch LL. Restricting access to palatable foods affects children's behavioral response, food selection, and intake. Am J Clin Nutr. 1999 Jun;69(6):1264-72. doi: 10.1093/ajcn/69.6.1264.

    PubMed 10357749

Questions about this trial

What is this clinical trial studying?

A study testing Food Ads and Non-food Ads in people with Childhood Obesity, run by Trustees of Dartmouth College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food-cue-related neural activity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03766191, which also lists 151 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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