Eating BehaviorsNCT00320177
Eating Behavior in Children
An observational study of Eating Behaviors, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Eating Behaviors
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2003to 28 Oct 2014
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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:
Read more
- 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.
- Conditions
- Eating Behaviors
- Keywords
- Binge Eating, Food Intake, Obesity, Melanocortin-4 Receptor Gene, Child, Macronutrient Composition
- Medical subject headings
- Feeding Behavior, Bulimia, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study start26 Nov 2003
- Study completion28 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Eating BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jack A Yanovski, M.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320177
- Sponsor's protocol ID
- 040050
- Other IDs
- 04-CH-0050
- Status last verified
- 28 Oct 2014
- First submitted
- 29 Apr 2006
- Last updated
- 12 Dec 2019
- Results posted
- No
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 8477283Smith 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 9989331Striegel-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 10664648Manoli 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 38271099Han 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 29718281Vannucci 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 24888295Cassidy 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 22365807Shomaker 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 20504975Tanofsky-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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behavior in Children
- ClinicalTrials.gov ID
- NCT00320177
- Acronym / sponsor ID
- 040050
- Conditions
- Eating Behaviors
- Keywords
- Binge Eating, Food Intake, Obesity, Melanocortin-4 Receptor Gene, Child, Macronutrient Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 26 Nov 2003
- Study completion
- 28 Oct 2014
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 8477283Spitzer 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.
- Background: PubMed 9989331Smith 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.
- Background: PubMed 10664648Striegel-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.
- Derived from this study: PubMed 38271099Manoli 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.
- Derived from this study: PubMed 29718281Han 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.
- Derived from this study: PubMed 24888295Vannucci 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.
- Derived from this study: PubMed 22365807Cassidy 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.
- Derived from this study: PubMed 20504975Shomaker 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.
- Derived from this study: PubMed 19144730Tanofsky-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A Yanovski, M.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behaviors, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 3 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 12 Dec 2019. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00320177, which also lists 9 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 12 Dec 2019; AzTrials last refreshed its copy on 30 Oct 2026.