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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 100% portion size
100% portion sizes of all foods served (baseline). To-go container and controls received this meal.
Behavioral: To-Go container
Subjects were provided a to-go container in which leftover foods would be packaged
Other: Control
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.
Behavioral: To-Go container
Subjects were provided a to-go container in which leftover foods would be packaged
Other: Control
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.
Behavioral: To-Go container
Subjects were provided a to-go container in which leftover foods would be packaged
Other: Control
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.
Behavioral: To-Go container
Subjects were provided a to-go container in which leftover foods would be packaged
Other: Control
Subjects were not provided a to-go container with the meal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
United States Department of Agriculture (USDA)
Jenny Craig, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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