- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03502096
Portion Size and To-go Container on Dinner Intake
April 10, 2018 updated by: Barbara J. Rolls, Penn State University
The Influence of the Provision of a To-go Container on the Portion Size Effect in Women
This study investigated whether the provision of a to-go container influenced the portion size effect at a meal.
Following a screening visit, women came to the lab once a week for 4 weeks to eat a meal of multiple foods.
At each visit, the portion size of the meal was varied in a counterbalanced order.
Prior to their first meal, women were randomly assigned to one of two groups: a group that would have their leftovers packaged to go (to-go group) and a group that did not have leftovers packaged (control group).
Women were instructed to eat ad libitum at the meals.
They also answered questions about hunger and fullness as well as food characteristics before and after each meal.
Following the final meal, subjects completed a series of questionnaires assessing subject characteristics as well as food characteristics.
It was hypothesized that the effect of portion size on intake would be attenuated in subjects who received a to-go container with the meal.
In addition, we aimed to identify any subject characteristics that moderated or exacerbated the portion size effect.
It was also of interest to determine whether the portion size effect on individual foods were influenced by food characteristics such as perceived value.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Regularly eats 3 meals/day
- Willing to avoid alcohol the day before and during test days
- Likes foods offered at test meals
- Body mass index 18 - 36 (kg/m*m)
Exclusion Criteria:
- Smokes
- Athlete in training
- Pregnant or breastfeeding
- Taking medication that may affect appetite or food intake
- Food allergies or dietary restrictions
- Currently have or recently been diagnosed with disease or disorder known to affect appetite
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100% portion size
100% portion sizes of all foods served (baseline).
To-go container and controls received this meal.
|
Subjects were provided a to-go container in which leftover foods would be packaged
Subjects were not provided a to-go container with the meal
|
Experimental: 125% portion size
125% of baseline portions served.
To-go container and controls received this meal.
|
Subjects were provided a to-go container in which leftover foods would be packaged
Subjects were not provided a to-go container with the meal
|
Experimental: 150% portion size
150% of baseline portions served.
To-go container and controls received this meal.
|
Subjects were provided a to-go container in which leftover foods would be packaged
Subjects were not provided a to-go container with the meal
|
Experimental: 175% portion size
175% of baseline portions served.
To-go container and controls received this meal.
|
Subjects were provided a to-go container in which leftover foods would be packaged
Subjects were not provided a to-go container with the meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the weight of food consumed
Time Frame: Weeks 1, 2, 3, and 4
|
Change in the weight of food consumed (in grams) across experimental conditions and intervention groups.
|
Weeks 1, 2, 3, and 4
|
Change in energy intake
Time Frame: Weeks 1, 2, 3, and 4
|
Change in energy intake (in kcal) across experimental conditions and intervention groups.
|
Weeks 1, 2, 3, and 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in energy density consumed
Time Frame: Weeks 1, 2, 3, and 4
|
Change in food energy density consumed (in kcal/g) across experimental conditions and intervention groups.
|
Weeks 1, 2, 3, and 4
|
Change in intake of individual foods
Time Frame: Weeks 1, 2, 3, and 4
|
Change in both the weight (g) and energy (kcal) consumed of individual foods served at the meal across experimental conditions and intervention groups.
|
Weeks 1, 2, 3, and 4
|
Changes in post-meal measures of satiety
Time Frame: Weeks 1, 2, 3, and 4
|
Changes in post-meal measures of satiety across experimental conditions and intervention groups using 100-mm visual analog scales.
|
Weeks 1, 2, 3, and 4
|
Changes in post-meal ratings of meal characteristics
Time Frame: Weeks 1, 2, 3, and 4
|
Changes in post-meal ratings of meal characteristics across experimental conditions and between subject groups using 100-mm visual analog scales.
|
Weeks 1, 2, 3, and 4
|
Changes in ratings of food properties
Time Frame: Weeks 1, 2, 3, and 4
|
Changes in post-meal ratings of food properties across experimental conditions and subject groups using 100-mm visual analog scales.
|
Weeks 1, 2, 3, and 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara J. Rolls, PhD, The Pennsylvania State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 18, 2018
Study Record Updates
Last Update Posted (Actual)
April 18, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PortionSize105
- R01DK059853 (U.S. NIH Grant/Contract)
- NIFA Grant 2011-67001-30117 (Other Grant/Funding Number: United States Department of Agriculture)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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