OverweightNCT00631644
Eating Behavior in Adolescents
An observational study of Overweight and Eating Behavior, 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 adolescents and determine if eating behavior is linked to genetics. Healthy adolescents between 13 and 17 years of age may be eligible for this study. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Eating Behavior, Binge Eating
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2008to 8 Sep 2015
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteers will qualify for participation in the study if they meet the following criteria:
- <TAB>Age 13-17 years.
- <TAB>Good general health as indicated by medical history and physical examination.
- <TAB>Negative urine glucose and normal electrolytes, hepatic, and thyroid function.
- <TAB>For the fMRI portion only: right handedness (required for standardization of responses).
- <TAB>For the fMRI portion only: female.
- <TAB>For the fMRI portion only: overweight (BMI greater than or equal to 85th percentile for age and sex).
Who cannot join
- Volunteers will be excluded if they have any of the following:
- <TAB>Medical problem likely to affect caloric intake.
- <TAB>History of any condition including psychiatric disorders in either child or their responsible parent that in the opinion of the investigators would impede competence to sign consent, interfere with adherence to procedures, or possibly hinder completion of the study.
- <TAB>Pregnancy.
- <TAB>Use of medication likely to affect caloric intake.
- <TAB>History of significant neurological injury or insult.
- <TAB>For the fMRI portion only: braces (or other metal) that would interfere with the fMRI procedure.
- <TAB>For the fMRI portion only: non-native English speakers (required for standardization of responses).
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 adolescents and determine if eating behavior is linked to genetics.
Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates come to the NIH Clinical Center at 8:00 AM to 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 adolescent sits inside the device for about 5 minutes and the machine determines body fat by measuring air movement. The adolescent 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 adolescent s general health and eating habits.
- Acclimatization to test meal conditions for the study. The adolescent is given a breakfast shake to drink.
Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this visit, the adolescent does the following:
- Eats food from a buffet of everyday foods that most kids eat.
- Fills out questionnaires.
- Tastes and rates the flavor of a variety of snack foods.
Read the detailed description
Little is known about the eating behaviors that place adolescents at heightened risk for overweight. In the proposed study, we aim to investigate the role that eating behaviors and genes may play in the development of overweight. Participants will be adolescent girls and boys from a racially/ethnically diverse sample of adolescents from the DC Metro community. Adolescent eating behavior will be observed during laboratory test meals. Adolescents will be provided with a large buffet of foods or a standard meal and instructed to eat until you are no longer hungry. Thirty minutes later, they will taste and rate a variety of highly palatable snack foods. Blood tests will be conducted to examine genes related to eating behavior. Assessments also will include affective states, degree of hunger, degree of fullness, body image satisfaction, disordered eating attitudes and behaviors, and measures of interpersonal interactions.
- Conditions
- Overweight, Eating Behavior, Binge Eating
- Keywords
- Adolescents, Eating Behavior, Eating in the Absence of Hunger, Disordered Eating, Food Intake, Macronutrient Composition, Obesity, Adolescent, Healthy Volunteer, HV
- Medical subject headings
- Overweight, 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 posted10 Mar 2008 (estimated)
- Study start5 Mar 2008
- Study completion8 Sep 2015
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 OverweightStudies 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
- Time perspective
- Prospective
- Enrolment
- 301 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
- Responsible party
- Sponsor
- 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
- NCT00631644
- Sponsor's protocol ID
- 080085
- Other IDs
- 08-CH-0085
- Status last verified
- 8 Sep 2015
- First submitted
- 7 Mar 2008
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PubMed 16595758Barros A. [Individual impression spoon from self polymerising plastics]. Zahnarztl Prax. 1967 Jan 1;18(1):1. No abstract available. German.
PubMed 5340113Taylor ED, Theim KR, Mirch MC, Ghorbani S, Tanofsky-Kraff M, Adler-Wailes DC, Brady S, Reynolds JC, Calis KA, Yanovski JA. Orthopedic complications of overweight in children and adolescents. Pediatrics. 2006 Jun;117(6):2167-74. doi: 10.1542/peds.2005-1832.
PubMed 16740861Suelter CS, Schvey N, Kelly NR, Shanks M, Thompson KA, Mehari R, Brady S, Yanovski SZ, Melby CL, Tanofsky-Kraff M, Yanovski JA, Shomaker LB. Relationship of pressure to be thin with gains in body weight and fat mass in adolescents. Pediatr Obes. 2018 Jan;13(1):14-22. doi: 10.1111/ijpo.12179. Epub 2016 Nov 16.
PubMed 27860465Schvey NA, Shomaker LB, Kelly NR, Pickworth CK, Cassidy O, Galescu O, Demidowich AP, Brady SM, Tanofsky-Kraff M, Yanovski JA. Pressure To Be Thin and Insulin Sensitivity Among Adolescents. J Adolesc Health. 2016 Jan;58(1):104-10. doi: 10.1016/j.jadohealth.2015.09.010.
PubMed 26707232Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.
PubMed 26210388Vannucci 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 24888295Reina SA, Shomaker LB, Mooreville M, Courville AB, Brady SM, Olsen C, Yanovski SZ, Tanofsky-Kraff M, Yanovski JA. Sociocultural pressures and adolescent eating in the absence of hunger. Body Image. 2013 Mar;10(2):182-90. doi: 10.1016/j.bodyim.2012.12.004. Epub 2013 Feb 7.
PubMed 23394966Shomaker LB, Tanofsky-Kraff M, Zocca JM, Courville A, Kozlosky M, Columbo KM, Wolkoff LE, Brady SM, Crocker MK, Ali AH, Yanovski SZ, Yanovski JA. Eating in the absence of hunger in adolescents: intake after a large-array meal compared with that after a standardized meal. Am J Clin Nutr. 2010 Oct;92(4):697-703. doi: 10.3945/ajcn.2010.29812. Epub 2010 Aug 18.
PubMed 20720255
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behavior in Adolescents
- ClinicalTrials.gov ID
- NCT00631644
- Acronym / sponsor ID
- 080085
- Conditions
- Overweight, Eating Behavior, Binge Eating
- Keywords
- Adolescents, Eating Behavior, Eating in the Absence of Hunger, Disordered Eating, Food Intake, Macronutrient Composition, Obesity, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 5 Mar 2008
- Study completion
- 8 Sep 2015
- First posted
- 10 Mar 2008 (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 adolescents and determine if eating behavior is linked to genetics.
Healthy adolescents between 13 and 17 years of age may be eligible for this study. Candidates come to the NIH Clinical Center at 8:00 AM to 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 adolescent sits inside the device for about 5 minutes and the machine determines body fat by measuring air movement. The adolescent 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 adolescent s general health and eating habits.
- Acclimatization to test meal conditions for the study. The adolescent is given a breakfast shake to drink.
Participants come to the NIH Clinical Center at 10:30 AM for laboratory meal testing. At this visit, the adolescent does the following:
- Eats food from a buffet of everyday foods that most kids eat.
- Fills out questionnaires.
- Tastes and rates the flavor of a variety of snack foods.
Detailed description
Little is known about the eating behaviors that place adolescents at heightened risk for overweight. In the proposed study, we aim to investigate the role that eating behaviors and genes may play in the development of overweight. Participants will be adolescent girls and boys from a racially/ethnically diverse sample of adolescents from the DC Metro community. Adolescent eating behavior will be observed during laboratory test meals. Adolescents will be provided with a large buffet of foods or a standard meal and instructed to eat until you are no longer hungry. Thirty minutes later, they will taste and rate a variety of highly palatable snack foods. Blood tests will be conducted to examine genes related to eating behavior. Assessments also will include affective states, degree of hunger, degree of fullness, body image satisfaction, disordered eating attitudes and behaviors, and measures of interpersonal interactions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Volunteers will qualify for participation in the study if they meet the following criteria:
- <TAB>Age 13-17 years.
- <TAB>Good general health as indicated by medical history and physical examination.
- <TAB>Negative urine glucose and normal electrolytes, hepatic, and thyroid function.
- <TAB>For the fMRI portion only: right handedness (required for standardization of responses).
Key exclusion criteria (8 listed)
- <TAB>Medical problem likely to affect caloric intake.
- <TAB>History of any condition including psychiatric disorders in either child or their responsible parent that in the opinion of the investigators would impede competence to sign consent, interfere with adherence to procedures, or possibly hinder completion of the study.
- <TAB>Pregnancy.
- <TAB>Use of medication likely to affect caloric intake.
- <TAB>History of significant neurological injury or insult.
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 6 Oct 2017.
- Background: PubMed 16595758Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Background: PubMed 5340113Barros A. [Individual impression spoon from self polymerising plastics]. Zahnarztl Prax. 1967 Jan 1;18(1):1. No abstract available. German.
- Background: PubMed 16740861Taylor ED, Theim KR, Mirch MC, Ghorbani S, Tanofsky-Kraff M, Adler-Wailes DC, Brady S, Reynolds JC, Calis KA, Yanovski JA. Orthopedic complications of overweight in children and adolescents. Pediatrics. 2006 Jun;117(6):2167-74. doi: 10.1542/peds.2005-1832.
- Derived from this study: PubMed 27860465Suelter CS, Schvey N, Kelly NR, Shanks M, Thompson KA, Mehari R, Brady S, Yanovski SZ, Melby CL, Tanofsky-Kraff M, Yanovski JA, Shomaker LB. Relationship of pressure to be thin with gains in body weight and fat mass in adolescents. Pediatr Obes. 2018 Jan;13(1):14-22. doi: 10.1111/ijpo.12179. Epub 2016 Nov 16.
- Derived from this study: PubMed 26707232Schvey NA, Shomaker LB, Kelly NR, Pickworth CK, Cassidy O, Galescu O, Demidowich AP, Brady SM, Tanofsky-Kraff M, Yanovski JA. Pressure To Be Thin and Insulin Sensitivity Among Adolescents. J Adolesc Health. 2016 Jan;58(1):104-10. doi: 10.1016/j.jadohealth.2015.09.010.
- Derived from this study: PubMed 26210388Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.
- 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 23394966Reina SA, Shomaker LB, Mooreville M, Courville AB, Brady SM, Olsen C, Yanovski SZ, Tanofsky-Kraff M, Yanovski JA. Sociocultural pressures and adolescent eating in the absence of hunger. Body Image. 2013 Mar;10(2):182-90. doi: 10.1016/j.bodyim.2012.12.004. Epub 2013 Feb 7.
- Derived from this study: PubMed 20720255Shomaker LB, Tanofsky-Kraff M, Zocca JM, Courville A, Kozlosky M, Columbo KM, Wolkoff LE, Brady SM, Crocker MK, Ali AH, Yanovski SZ, Yanovski JA. Eating in the absence of hunger in adolescents: intake after a large-array meal compared with that after a standardized meal. Am J Clin Nutr. 2010 Oct;92(4):697-703. doi: 10.3945/ajcn.2010.29812. Epub 2010 Aug 18.
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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 Overweight and Eating Behavior, 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 7 inclusion and 8 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 6 Oct 2017. 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 NCT00631644, 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 6 Oct 2017.