Fast Food Feeding in Youth

NCT ID: NCT00121706

Last Updated: 2006-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Condition A (see detailed summary)

Intervention Type BEHAVIORAL

Condition B (see detailed summary)

Intervention Type BEHAVIORAL

Condition C (see detailed summary)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Cara B Ebbeling, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

David S Ludwig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15199032 (View on PubMed)

Other Identifiers

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P30DK040561

Identifier Type: NIH

Identifier Source: org_study_id

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