We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Fast Food Feeding in Youth

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.
ClinicalTrials.gov Identifier: NCT00121706
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 6, 2006
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obesity Behavioral: Condition A (see detailed summary) Behavioral: Condition B (see detailed summary) Behavioral: Condition C (see detailed summary)

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Fast Food Feeding in Youth
Study Start Date : July 2005
Estimated Study Completion Date : September 2005
Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

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