- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121706
Fast Food Feeding in Youth
February 3, 2006 updated by: Boston Children's Hospital
The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.
Study Overview
Status
Completed
Conditions
Detailed Description
Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.
- Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).
- Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.
- Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).
Study Type
Interventional
Enrollment
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index (BMI) between the 85th and 98th percentiles for sex and age
- Consumption of fast food at least one time per week
- Willingness to eat the foods specified in the research methods
- Parent/guardian willing and able to cooperate
- Access to a working telephone
Exclusion Criteria:
- Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)
- Taking any prescription medication that may affect food intake
- Current smoking (i.e., any tobacco in the last month)
- Previous diagnosis of an eating disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Energy (calorie) intake during fast food feedings, assessed by direct observation
|
Secondary Outcome Measures
Outcome Measure |
---|
Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
July 15, 2005
First Submitted That Met QC Criteria
July 15, 2005
First Posted (Estimate)
July 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 6, 2006
Last Update Submitted That Met QC Criteria
February 3, 2006
Last Verified
January 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- P30DK040561 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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