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Fast Food Feeding in Youth

This study has been completed.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00121706
First received: July 15, 2005
Last updated: February 3, 2006
Last verified: January 2006
  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 Blind
Primary Purpose: Prevention
Official Title: Fast Food Feeding in Youth

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

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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121706

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

Publications:
ClinicalTrials.gov Identifier: NCT00121706     History of Changes
Other Study ID Numbers: P30 DK40561
Study First Received: July 15, 2005
Last Updated: February 3, 2006
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014