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The Development of an Eating Laboratory for Overweight Adolescents

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ClinicalTrials.gov Identifier: NCT00764127
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.

Condition or disease
Adolescent Obesity

Detailed Description:

The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.

The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.

Study Design

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Development of an Eating Laboratory for Overweight Adolescents
Study Start Date : February 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010
Groups and Cohorts

Obese Control
Normal Control

Outcome Measures

Primary Outcome Measures :
  1. Caloric intake [ Time Frame: post-meal ]

Biospecimen Retention:   Samples Without DNA

10 cc (2 teaspoons) of blood will be drawn during the screening assessment to screen for medical illness.

60 cc (12 teaspoons) of blood will be drawn from an indwelling IV catheter during the single-item meal to assay for meal-related hormones (ghrelin, leptin,cholecystokinin, insulin, peptideY). Bariatric surgery participants may have an additional 20 cc of blood taken to measure glucose responses to the meal.

Eligibility Criteria

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample

Inclusion Criteria:

  • BMI Index Enrollment in bariatric surgery program Ages 12-18

Exclusion Criteria:

  • Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764127

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Michael Devlin, M.D. New York State Psychiatric Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00764127     History of Changes
Other Study ID Numbers: #5217 DK074503-01
R21DK074503 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by New York State Psychiatric Institute:
bariatric surgery

Additional relevant MeSH terms:
Pediatric Obesity
Body Weight
Signs and Symptoms
Nutrition Disorders