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Completed

NCT Number: NCT00764127

The Development of an Eating Laboratory for Overweight Adolescents

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Caloric intake

    Time frame: post-meal

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2008
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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