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CompletedNCT00320177Updated Dec 12, 2019

Eating Behavior in Children

An observational study in Eating Behaviors, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational

Study type
Observational
Enrollment
263
Ages
8 Years to 17 Years
Sex
All
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Study summary

This study will explore the eating habits of children and determine if eating behavior is linked to genetics.

Children between 8 and 17 years of age may be eligible for this study. It will include children who have experienced loss of control over eating, children who report overeating without loss of control, and children who report experiencing neither of the above. Candidates will be screened with the following:

  • Medical history and brief physical examination, including height, weight, and body fat measurements. Body fat is measured using a device called a Bod Pod. The child sits inside the device for about 5 minutes and the machine determines body fat by measuring air movement. The child must wear a tight-fitting swimsuit for this test.
  • Urine test to look for sugar or protein in the urine and to test for pregnancy in females.
  • Blood tests for routine chemistries and for gene studies related to eating behaviors.
  • Questionnaires and interviews about the child's general health and eating habits.
  • Acclimatization to test meal conditions for the study. The child is given a yogurt shake to drink and fills out rating scales before and after the drink.

Participants will come to the Clinical Center two times at 8:30 a.m. for laboratory meal testing. At each visit, the child will do the following:

  • In the morning, eat a breakfast of apple juice and a buttered English muffin.
  • Between 10 a.m. and 2 p.m., pursue activities at the Clinical Center recreation facility or the NIH classroom, but may not eat or drink anything that contains calories.
  • At 2 p.m., fill out rating scales about his or her hunger level.
  • At 2:30 p.m., eat from a food buffet that will be made available.
  • After eating, repeat rating scales about hunger level.

The procedure for both visits will be the same, except at one visit the child will be instructed to eat as much as you would eat at a normal meal, and at the other visit, the instruction will be to let yourself go and eat as much as you want.

Read the detailed description

Little is known about the eating habits of children under laboratory conditions. In this exploratory study, we aim to examine the relationships between measured food intake during meals, binge eating behaviors as assessed by interview, and polymorphisms in genes believed to be involved in the regulation of energy intake. We will study children who report they have experienced loss of control over eating, children who report overeating without loss of control, and children who report neither of these episodes, and assess the impact of two different meal instructions on their eating behavior. We will ask children to eat a meal in the laboratory setting on two occasions. The only difference between the two meals will be a pre-meal instruction: Participants will be asked either to eat 'normally' (the 'normal meal' instruction) or to 'let yourself go' (the 'binge meal' instruction). Participants will be assessed for affective state; degree of hunger, fullness, and desire to binge; presence of overeating or loss of control; eating attitudes and dieting; and general school and social adjustment. Participants' DNA will be sequenced to seek polymorphisms in genes relevant for appetite, such as the leptin and melanocortin 4 receptor genes, to examine whether genetic variation in the leptin signaling pathway can account for variation in reported or actual eating behaviors. Samples will also be obtained for hormones believed to be relevant for food intake. By accurately describing eating behavior in children in relation to their age, weight, history of dieting and/or overeating behavior, and genetic variation, we can refine current theoretical models of disordered eating.

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Conditions studied

  • Eating Behaviors

Keywords

  • Binge Eating
  • Food Intake
  • Obesity
  • Melanocortin-4 Receptor Gene
  • Child
  • Macronutrient Composition
03

In context

Feeding Behavior

243 studies on the registry are indexed under Feeding Behavior; 101 are open to participants now.

This study's enrollment of 263 is above the median of 150 across 59 observational studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 422 studies on the registry; 25 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Good general health.
  • Age greater than 7 and less than 18 years.
  • Participants must have negative urine glucose and normal electrolytes, hepatic, and thyroid function or they will be referred for treatment.

Exclusion criteria

EXCLUSION CRITERIA:

  • Any major medical problem likely to affect caloric intake (e.g., significant cardiac or pulmonary disease likely to result in hypoxia or decreased perfusion).
  • History of an eating disorder, other than binge eating disorder, or a current psychiatric disorder. Identification of any such illness will lead to immediate referral to a mental health professional.
  • Recent weight change of greater than 5 lbs. within the previous three (3) months.
  • Pregnancy. If a potential participant is found to be pregnant, we will inform the child, as an 'emancipated minor,' and let her inform her parent(s).
  • Individuals who have, or whose parent or guardians have, current substance abuse or a diagnosed psychiatric disorder or other condition that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
  • Participants currently prescribed SSRI's neuroleptics, tricyclics, stimulants, or any medication likely to affect caloric intake. Recent use (with six months) of weight loss medications.
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Study design

Enrollment
263 participants (actual)
06

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
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References and documents

Publications

  • Spitzer RL, Yanovski S, Wadden T, Wing R, Marcus MD, Stunkard A, Devlin M, Mitchell J, Hasin D, Horne RL. Binge eating disorder: its further validation in a multisite study. Int J Eat Disord. 1993 Mar;13(2):137-53. PubMed 8477283 ↗
  • Smith DE, Marcus MD, Lewis CE, Fitzgibbon M, Schreiner P. Prevalence of binge eating disorder, obesity, and depression in a biracial cohort of young adults. Ann Behav Med. 1998 Summer;20(3):227-32. doi: 10.1007/BF02884965. PubMed 9989331 ↗
  • Striegel-Moore RH, Wilfley DE, Pike KM, Dohm FA, Fairburn CG. Recurrent binge eating in black American women. Arch Fam Med. 2000 Jan;9(1):83-7. doi: 10.1001/archfami.9.1.83. PubMed 10664648 ↗
  • Manoli I, Sysol JR, Head PE, Epping MW, Gavrilova O, Crocker MK, Sloan JL, Koutsoukos SA, Wang C, Ktena YP, Mendelson S, Pass AR, Zerfas PM, Hoffmann V, Vernon HJ, Fletcher LA, Reynolds JC, Tsokos MG, Stratakis CA, Voss SD, Chen KY, Brown RJ, Hamosh A, Berry GT, Chen XS, Yanovski JA, Venditti CP. Lipodystrophy in methylmalonic acidemia associated with elevated FGF21 and abnormal methylmalonylation. JCI Insight. 2024 Feb 22;9(4):e174097. doi: 10.1172/jci.insight.174097. PubMed 38271099 ↗
  • Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496. PubMed 29718281 ↗
  • Vannucci A, Tanofsky-Kraff M, Ranzenhofer LM, Kelly NR, Hannallah LM, Pickworth CK, Grygorenko MV, Brady SM, Condarco TA, Kozlosky M, Demidowich AP, Yanovski SZ, Shomaker LB, Yanovski JA. Puberty and the manifestations of loss of control eating in children and adolescents. Int J Eat Disord. 2014 Nov;47(7):738-47. doi: 10.1002/eat.22305. Epub 2014 May 30. PubMed 24888295 ↗
  • Cassidy OL, Matheson B, Osborn R, Vannucci A, Kozlosky M, Shomaker LB, Yanovski SZ, Tanofsky-Kraff M. Loss of control eating in African-American and Caucasian youth. Eat Behav. 2012 Apr;13(2):174-8. doi: 10.1016/j.eatbeh.2012.01.003. Epub 2012 Jan 16. PubMed 22365807 ↗
  • Shomaker LB, Tanofsky-Kraff M, Savastano DM, Kozlosky M, Columbo KM, Wolkoff LE, Zocca JM, Brady SM, Yanovski SZ, Crocker MK, Ali A, Yanovski JA. Puberty and observed energy intake: boy, can they eat! Am J Clin Nutr. 2010 Jul;92(1):123-9. doi: 10.3945/ajcn.2010.29383. Epub 2010 May 26. PubMed 20504975 ↗
  • Tanofsky-Kraff M, McDuffie JR, Yanovski SZ, Kozlosky M, Schvey NA, Shomaker LB, Salaita C, Yanovski JA. Laboratory assessment of the food intake of children and adolescents with loss of control eating. Am J Clin Nutr. 2009 Mar;89(3):738-45. doi: 10.3945/ajcn.2008.26886. Epub 2009 Jan 14. PubMed 19144730 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2003 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2006
First posted
May 3, 2006
Start
Nov 26, 2003
Completion
Oct 28, 2014
Last update
Dec 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00320177
First posted
May 3, 2006
Start date
Nov 26, 2003
Completion
Oct 28, 2014
Last update
Dec 12, 2019

Study contacts

Jack A Yanovski, M.D.
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
View the source record on ClinicalTrials.gov ↗

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