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Fast Food Feeding in Youth

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121706
First Posted: July 21, 2005
Last Update Posted: February 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Harvard School of Public Health
Information provided by:
Boston Children’s Hospital
  Purpose
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.

Condition Intervention
Obesity Behavioral: Condition A (see detailed summary) Behavioral: Condition B (see detailed summary) Behavioral: Condition C (see detailed summary)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Fast Food Feeding in Youth

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Energy (calorie) intake during fast food feedings, assessed by direct observation

Secondary Outcome Measures:
  • Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology

Estimated Enrollment: 18
Study Start Date: July 2005
Estimated Study Completion Date: September 2005
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121706


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Harvard School of Public Health
Investigators
Principal Investigator: Cara B Ebbeling, PhD Boston Children’s Hospital
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00121706     History of Changes
Other Study ID Numbers: P30DK040561 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2005
First Posted: July 21, 2005
Last Update Posted: February 6, 2006
Last Verified: January 2006