Adolescent ObesityTeen LABSNCT00721838
Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
An observational study of Adolescent Obesity and Eating Behavior, run by University of Pennsylvania at 5 sites in United States.
Trial summary
to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Obesity, Eating Behavior, Dietary Intake
- How many people
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2009to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Baylor College of Medicine
Houston, Texas, 77030
The University of Pennsylvania Weight and Eating Disorder Program
Philadelphia, Pennsylvania, 19104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15260
About this study
to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery
Read the 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.
- Conditions
- Adolescent Obesity, Eating Behavior, Dietary Intake
- Keywords
- adolescent obesity, eating behavior, dietary intake
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Surgery group | |
| 2 | Control - Lifestyle modification program |
What is being measured
The primary outcome is the main question the study is designed to answer.
dietary intake
Measured: BL, 3, 6, 12, and 24 mo
eating behavior
Measured: BL, 3, 6, 12, and 24 mo
Secondary outcomes (1)
nausea, vomiting, and gastric dumping
Measured: BL, 3, 6, 12 and 24 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Medical Center, Cincinnati, Baylor College of Medicine, University of Pittsburgh, University of Alabama at Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721838
- Sponsor's protocol ID
- DK072493
- Other IDs
- U01DK072493
- Acronym
- Teen LABS
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2008
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake and Eating Behaviors in Adolescents Who Undergo Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00721838
- Acronym / sponsor ID
- Teen LABS / DK072493
- Conditions
- Adolescent Obesity, Eating Behavior, Dietary Intake
- Keywords
- adolescent obesity, eating behavior, dietary intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Children's Hospital Medical Center, Cincinnati, Baylor College of Medicine, University of Pittsburgh, University of Alabama at Birmingham
- Study start
- Feb 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Surgery group |
| 2 | – | –Control - Lifestyle modification program |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
dietary intake
Time frame: BL, 3, 6, 12, and 24 mo
eating behavior
Time frame: BL, 3, 6, 12, and 24 mo
1 secondary outcome
nausea, vomiting, and gastric dumping
Time frame: BL, 3, 6, 12 and 24 mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Obesity and Eating Behavior, run by University of Pennsylvania at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dietary intake (time frame: BL, 3, 6, 12, and 24 mo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.