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Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery (Teen LABS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721838
First Posted: July 24, 2008
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
Baylor College of Medicine
University of Pittsburgh
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

Condition
Adolescent Obesity Eating Behavior Dietary Intake

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • dietary intake [ Time Frame: BL, 3, 6, 12, and 24 mo ]
  • eating behavior [ Time Frame: BL, 3, 6, 12, and 24 mo ]

Secondary Outcome Measures:
  • nausea, vomiting, and gastric dumping [ Time Frame: BL, 3, 6, 12 and 24 mo ]

Enrollment: 160
Study Start Date: February 2009
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Surgery group
2
Control - Lifestyle modification program

Detailed Description:
The dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. The main trial of the Teen-LABS consortium is not studying dietary intake and eating behavior before and after bariatric surgery. The consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will assess changes in dietary intake and eating behavior in 110 extremely obese adolescents who undergo bariatric surgery as part of the main Teen-LABS study. These individuals will be recruited from one of 4 Teen-LABS sites: Baylor College of Medicine, Cincinnati Children's Hospital Medical Center, University of Alabama at Birmingham, and the University of Pittsburgh Medical Center. Changes in bariatric surgery patients will be compared to those of 110 obese adolescents treated with a lifestyle modification program designed to produce an 8% weight loss. These individuals will be recruited from a study at the Children's Hospital of Philadelphia (PI: Robert Berkowitz, M.D.) which will be ongoing at the same time and will include the same measures as those proposed in this application.
Criteria

Inclusion Criteria:

  • 19 years old or younger
  • have a BMI > 30 kg/m2
  • have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management.
  • must demonstrate reasonable decision making abilities
  • must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation).
  • Participants will be from all racial and ethnic groups and be both male and female.

Exclusion Criteria:

  • We will not exclude participants from this trial based on health status or medication usage. Instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.
  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): NCT00721838


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
The University of Pennsylvania Weight and Eating Disorder Program
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Hospital Medical Center, Cincinnati
Baylor College of Medicine
University of Pittsburgh
University of Alabama at Birmingham
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00721838     History of Changes
Other Study ID Numbers: DK072493
U01DK072493 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2008
First Posted: July 24, 2008
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
adolescent obesity
eating behavior
dietary intake

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