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

This study is currently recruiting participants.
Verified December 2011 by University of Pennsylvania
Sponsor:
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:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00721838
First received: July 22, 2008
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • dietary intake [ Time Frame: BL, 3, 6, 12, and 24 mo ] [ Designated as safety issue: No ]
  • eating behavior [ Time Frame: BL, 3, 6, 12, and 24 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nausea, vomiting, and gastric dumping [ Time Frame: BL, 3, 6, 12 and 24 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (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

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721838

Contacts
Contact: David B Sarwer, Ph.D. 215-898-7314 dsarwer@mail.med.upenn.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Meg Zeller, Ph.D.     513-636-2712     meg.zeller@cchmc.org    
Principal Investigator: Meg Zeller, Ph.D.            
United States, Pennsylvania
The University of Pennsylvania Weight and Eating Disorder Program Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh School of Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
Baylor College of Medicine Recruiting
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

No publications provided

Responsible Party: David Sarwer, Ph.D, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00721838     History of Changes
Other Study ID Numbers: DK072493, U01DK072493
Study First Received: July 22, 2008
Last Updated: December 2, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 22, 2013