Fast Food Feeding in Youth | NCT00121706

Studies
Fast Food Feeding in Youth

NCT00121706

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Feb 6, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Obesity

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Sep 2005

First Submitted Date

Jul 15, 2005

First Submission Date that Met QC Criteria

Jul 15, 2005

First Posted Date

Jul 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2006

Last Update Posted Date

Feb 6, 2006Estimated

Name	Class
Harvard School of Public Health (HSPH)	OTHER

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Condition A (see detailed summary)	Behavioral
Condition B (see detailed summary)	Behavioral
Condition C (see detailed summary)	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Energy (calorie) intake during fast food feedings, assessed by direct observation

Secondary Outcomes

Measure	Description	Time Frame
Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cara B Ebbeling, PhD	Boston Children's Hospital	Principal Investigator
David S Ludwig, MD, PhD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15199032	Background	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases