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Completed

NCT Number: NCT00721838

Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery

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

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Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. dietary intake

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

  2. eating behavior

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

Secondary outcomes

  1. nausea, vomiting, and gastric dumping

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • 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

Registry information

Acronym: Teen LABS

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2008
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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