The Development of an Eating Laboratory for Overweight Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00764127
First received: September 30, 2008
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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
Adolescent Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Development of an Eating Laboratory for Overweight Adolescents

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Caloric intake [ Time Frame: post-meal ] [ Designated as safety issue: No ]

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.


Enrollment: 36
Study Start Date: February 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese Control
Normal Control
OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764127

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Michael Devlin, M.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00764127     History of Changes
Other Study ID Numbers: #5217 DK074503-01, R21DK074503
Study First Received: September 30, 2008
Last Updated: January 30, 2013
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
adolescent
obesity
bariatric surgery
eating

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

ClinicalTrials.gov processed this record on August 28, 2014