Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Eating Behavior Clinical Trial

— Teen LABS  

Official title:

Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721838
• Other study ID #: DK072493
• Secondary ID: U01DK072493
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: August 18, 2016
• Start date: February 2009
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adolescent Obesity
• Dietary Intake
• Eating Behavior
• Pediatric Obesity

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	The University of Pennsylvania Weight and Eating Disorder Program	Philadelphia	Pennsylvania
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	Baylor College of Medicine, Children's Hospital Medical Center, Cincinnati, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Alabama at Birmingham, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dietary intake		BL, 3, 6, 12, and 24 mo	No
Primary	eating behavior		BL, 3, 6, 12, and 24 mo	No
Secondary	nausea, vomiting, and gastric dumping		BL, 3, 6, 12 and 24 mo	No