Adolescent ObesityNCT00764127
The Development of an Eating Laboratory for Overweight Adolescents
An observational study of Adolescent Obesity, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Obesity
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2010
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: community sample
Who may be able to join
- BMI Index Enrollment in bariatric surgery program Ages 12-18
Who cannot join
- Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.
Read the detailed description
The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.
The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.
- Conditions
- Adolescent Obesity
- Keywords
- adolescent, obesity, bariatric surgery, eating
- Medical subject headings
- Pediatric Obesity, Obesity
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 |
|---|---|---|
| Obese Control | Not described | |
| Normal Control | Not described | |
| OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
Measured: post-meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Devlin, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764127
- Sponsor's protocol ID
- #5217 DK074503-01
- Other IDs
- R21DK074503
- Status last verified
- Jan 2013
- First submitted
- 30 Sep 2008
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sysko R, Devlin MJ, Schebendach J, Tanofsky-Kraff M, Zimmerli E, Korner J, Yanovski JA, Zitsman JL, Walsh BT. Hormonal responses and test meal intake among obese teenagers before and after laparoscopic adjustable gastric banding. Am J Clin Nutr. 2013 Nov;98(5):1151-61. doi: 10.3945/ajcn.113.061762. Epub 2013 Aug 28.
PubMed 23985807
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of an Eating Laboratory for Overweight Adolescents
- ClinicalTrials.gov ID
- NCT00764127
- Acronym / sponsor ID
- #5217 DK074503-01
- Conditions
- Adolescent Obesity
- Keywords
- adolescent, obesity, bariatric surgery, eating
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Oct 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.
The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.
Detailed description
The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.
The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese Control | – | – |
| Normal Control | – | – |
| OVERWEIGHT ADOLESCENT PATIENTS UNDERGOING BARIATRIC SURGERY | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- BMI Index Enrollment in bariatric surgery program Ages 12-18
Key exclusion criteria (1 listed)
- Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal
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
Caloric intake
Time frame: post-meal
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 31 Jan 2013.
- Derived from this study: PubMed 23985807Sysko R, Devlin MJ, Schebendach J, Tanofsky-Kraff M, Zimmerli E, Korner J, Yanovski JA, Zitsman JL, Walsh BT. Hormonal responses and test meal intake among obese teenagers before and after laparoscopic adjustable gastric banding. Am J Clin Nutr. 2013 Nov;98(5):1151-61. doi: 10.3945/ajcn.113.061762. Epub 2013 Aug 28.
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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.
Michael Devlin, M.D. principal investigator
New York State Psychiatric Institute
1 site 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, run by New York State Psychiatric Institute at 1 site 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 1 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Caloric intake (time frame: post-meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764127, which also lists 1 linked publication.
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 31 Jan 2013.