NCT00121706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2005

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

February 6, 2006

Status Verified

January 1, 2006

First QC Date

July 15, 2005

Last Update Submit

February 3, 2006

Conditions

Obesity

Outcome Measures

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

Interventions

Condition A (see detailed summary)BEHAVIORAL
Condition B (see detailed summary)BEHAVIORAL
Condition C (see detailed summary)BEHAVIORAL

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 15199032BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cara B Ebbeling, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

  • David S Ludwig, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

July 1, 2005

Study Completion

September 1, 2005

Last Updated

February 6, 2006

Record last verified: 2006-01

Locations

US(1)