Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

NCT00721838 | Completed

• 2 other identifiers: DK072493U01DK072493
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Adolescent Obesity; Eating Behavior; Dietary Intake

Keywords

adolescent obesity; eating behavior; dietary intake

Outcome Measures

Primary Outcomes (2)

• dietary intake

  BL, 3, 6, 12, and 24 mo

• eating behavior

  BL, 3, 6, 12, and 24 mo

Secondary Outcomes (1)

• nausea, vomiting, and gastric dumping

  BL, 3, 6, 12 and 24 mo

Study Arms (2)

1

Surgery group

2

Control - Lifestyle modification program

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

The University of Pennsylvania Weight and Eating Disorder Program

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15260, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (5)