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Clinical Trials/NCT00721838
NCT00721838
Completed
Not Applicable

Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

University of Pennsylvania5 sites in 1 country160 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Obesity
Sponsor
University of Pennsylvania
Enrollment
160
Locations
5
Primary Endpoint
dietary intake
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
July 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

dietary intake

Time Frame: BL, 3, 6, 12, and 24 mo

eating behavior

Time Frame: BL, 3, 6, 12, and 24 mo

Secondary Outcomes

  • nausea, vomiting, and gastric dumping(BL, 3, 6, 12 and 24 mo)

Study Sites (5)

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