NCT00200213

Brief Summary

Specific Aims: Environmental factors contributing to overconsumption, such as larger food portion sizes, may be contributing to the obesity epidemic. The objective of the proposed study is to examine the independent and combined effects of portion size and quantity of food on intake in normal weight males and females. Participants will be randomly assigned to one of four conditions varying in the portion size and quantity of junk food provided: small quantity of food packaged in small portions (SSP), small quantity of food packaged in large portions (SLP), large quantity of food packaged in small portions (LSP), and large quantity of food packaged in large portions (LLP). A box containing four different junk foods, packaged according to one of the four conditions, will be given to participants to take home for three days. The total amount of food consumed from the box over the three days will be measured. It is anticipated that portion size and quantity of food, both independently and combined, will influence intake, such that larger portion sizes and quantity of food provided to participants will produce greater intake.Subject Population: We propose to recruit 60 healthy men and women, aged 18-50 years, with a body mass index (BMI) of less than or equal to 28. Participants will be non-smokers, unrestrained eaters, and have no known food allergies to the foods used in the investigation.Methods/Design: Participants will be randomly assigned to one of four conditions, varying in portion size (small versus large) and quantity of food provided (small versus large). A box containing four junk foods, packaged according to one of the conditions, will be provided to participants. They will be encouraged to eat as much or as little of the food as they want, but to at least taste each of the four foods over the three-day period. During this time, they will be instructed to not eat any other junk foods. At the end of the three-day period, participants will return the box with any remaining uneaten junk food.Data Analyses: The dependent variables, the amount of grams and kcals consumed from the provided junk foods, will be examined between the four different conditions.Significance: If portion size and quantity are related to intake, subsequent studies will develop clinical interventions related to reducing portion size and/or quantity of food available in the household.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of food eaten

Secondary Outcomes (1)

  • Liking of foods in study

Interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, non-smoking, normal- and over-weight (body mass index \[BMI\] \< 30) unrestrained, males and females, who regularly eat junk foods (consume junk foods \> 3 times per week).

You may not qualify if:

  • Participants will be excluded if they are not between the ages of 18 and 50, smoke, following a weight loss diet, an athlete in training, pregnant or breastfeeding, or have a health condition or use medication that affects eating or requires specialized diet therapy (e.g., diabetes). Additionally, if participants rarely consume junk foods (\< 2 times per week) or have allergies or unfavorable preferences towards foods used in the investigation they will be excluded from the study. Participants will also be excluded if they are a restrained eater (scoring \> 12 on the Three Factor Eating Questionnaire \[TFEQ\] \[Stunkard \& Messick, 1985\]) or report being a binge eater.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Feeding BehaviorObesity

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hollie A Raynor, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Study Completion

March 1, 2005

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations