Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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).


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


Study is Available At:


Original ID:

P30 DK40561


NCT ID:

NCT00121706


Secondary ID:


Study Acronym:


Brief Title:

Fast Food Feeding in Youth


Official Title:

Fast Food Feeding in Youth


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Boston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Cros


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:


Overall Contact Information

Official Name:Cara B Ebbeling, PhD
Principal Investigator
Children's Hospital Boston

Study Dates

Start Date:July 2005
Completion Date:September 2005
Verification Date:January 2006
Last Changed Date:February 3, 2006
First Received Date:July 15, 2005

Study Outcomes

Outcome Type:Secondary 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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Energy (calorie) intake during fast food feedings, assessed by direct observation
Safety Issues:False

Study Interventions

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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Boston
Agency Class:Other
Agency Type:Collaborator
Agency Name:Harvard School of Public Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:15199032

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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