NCT03502096

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

April 3, 2018

Last Update Submit

April 10, 2018

Conditions

Keywords

portion sizefood intakeenergy intakefood choice

Outcome Measures

Primary Outcomes (2)

  • Change in the weight of food consumed

    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

    Change in energy intake (in kcal) across experimental conditions and intervention groups.

    Weeks 1, 2, 3, and 4

Secondary Outcomes (5)

  • Change in energy density consumed

    Weeks 1, 2, 3, and 4

  • Change in intake of individual foods

    Weeks 1, 2, 3, and 4

  • Changes in post-meal measures of satiety

    Weeks 1, 2, 3, and 4

  • Changes in post-meal ratings of meal characteristics

    Weeks 1, 2, 3, and 4

  • Changes in ratings of food properties

    Weeks 1, 2, 3, and 4

Study Arms (4)

100% portion size

EXPERIMENTAL

100% portion sizes of all foods served (baseline). To-go container and controls received this meal.

Behavioral: To-Go containerOther: Control

125% portion size

EXPERIMENTAL

125% of baseline portions served. To-go container and controls received this meal.

Behavioral: To-Go containerOther: Control

150% portion size

EXPERIMENTAL

150% of baseline portions served. To-go container and controls received this meal.

Behavioral: To-Go containerOther: Control

175% portion size

EXPERIMENTAL

175% of baseline portions served. To-go container and controls received this meal.

Behavioral: To-Go containerOther: Control

Interventions

To-Go containerBEHAVIORAL

Subjects were provided a to-go container in which leftover foods would be packaged

100% portion size125% portion size150% portion size175% portion size
ControlOTHER

Subjects were not provided a to-go container with the meal

100% portion size125% portion size150% portion size175% portion size

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Barbara J. Rolls, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: The two factors were meal portion size and provision of a to-go container. The portion size factor was within-subjects (crossover). All subjects received each of the 4 portions served (the order in which portions were served was counterbalanced). The container factor was between-subjects. Subjects were randomly assigned to 1 of 2 groups: one group had uneaten food packaged to take home, the other group (control) did not.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Director of the Laboratory for the Study of Human Ingestive Behavior

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 18, 2018

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04