Clinical trial NCT00721838: Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
Official title: Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Obesity
Eating Behavior
Dietary Intake
Keywords: adolescent obesity
eating behavior
dietary intake
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Children's Hospital Medical Center, Cincinnati
name: Baylor College of Medicine
name: University of Pittsburgh
name: University of Alabama at Birmingham
First posted: 2008-07-24
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: dietary intake
timeFrame: BL, 3, 6, 12, and 24 mo
measure: eating behavior
timeFrame: BL, 3, 6, 12, and 24 mo
Secondary outcomes:
measure: nausea, vomiting, and gastric dumping
timeFrame: BL, 3, 6, 12 and 24 mo
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: The University of Pennsylvania Weight and Eating Disorder Program
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: