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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 29, 2006 | ||||||||
| Last Updated Date | September 9, 2009 | ||||||||
| Start Date ICMJE | November 2003 | ||||||||
| Estimated Primary Completion Date | May 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00320177 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Eating Behavior in Children | ||||||||
| Official Title ICMJE | Eating Behavior in Children | ||||||||
| Brief 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:
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:
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. |
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| 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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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Eating Behaviors | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 275 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | May 2005 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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: 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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| Gender | Both | ||||||||
| Ages | 8 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00320177 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 040050, 04-CH-0050 | ||||||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | August 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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