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CompletedNCT00121706Updated Feb 6, 2006

Fast Food Feeding in Youth

An interventional study of Condition A (see detailed summary) and Condition B (see detailed summary) in Obesity, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-02-06.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
18 participants

Interventions

  • BehavioralCondition A (see detailed summary)
  • BehavioralCondition B (see detailed summary)
  • BehavioralCondition C (see detailed summary)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

1 site
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. JAMA. 2004 Jun 16;291(23):2828-33. doi: 10.1001/jama.291.23.2828. PubMed 15199032 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00121706
Lead sponsor
Boston Children's Hospital
Collaborators
Harvard School of Public Health (HSPH)
First posted
Jul 21, 2005
Start date
Jul 2005
Completion
Sep 2005
Last update
Feb 6, 2006

Study contacts

Cara B Ebbeling, PhD
principal investigator · Boston Children's Hospital
David S Ludwig, MD, PhD
principal investigator · Boston Children's Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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