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ObesityNCT03502096

Portion Size and To-go Container on Dinner Intake

A study testing To-Go container in people with Obesity and Eating Behavior, run by Penn State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Obesity, Eating Behavior
What is being tested?
To-Go container
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
No sites listed yet
Study dates
Oct 2016to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

Official title: 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.

Being tested
To-Go container, Control
Keywords
portion size, food intake, energy intake, food choice
Medical subject headings
Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • To-Go containerBehavioural

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

  • ControlOther

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

Study groups in NCT03502096
Study groupRoleWhat they receive
100% portion sizeExperimental100% portion sizes of all foods served (baseline). To-go container and controls received this meal.
Receives: Behavioral: To-Go container; Other: Control
125% portion sizeExperimental125% of baseline portions served. To-go container and controls received this meal.
Receives: Behavioral: To-Go container; Other: Control
150% portion sizeExperimental150% of baseline portions served. To-go container and controls received this meal.
Receives: Behavioral: To-Go container; Other: Control
175% portion sizeExperimental175% of baseline portions served. To-go container and controls received this meal.
Receives: Behavioral: To-Go container; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the weight of food consumed

    Change in the weight of food consumed (in grams) across experimental conditions and intervention groups.

    Measured: Weeks 1, 2, 3, and 4

  2. Change in energy intake

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

    Measured: Weeks 1, 2, 3, and 4

Secondary outcomes (5)

  1. Change in energy density consumed

    Change in food energy density consumed (in kcal/g) across experimental conditions and intervention groups.

    Measured: Weeks 1, 2, 3, and 4

  2. Change in intake of individual foods

    Change in both the weight (g) and energy (kcal) consumed of individual foods served at the meal across experimental conditions and intervention groups.

    Measured: Weeks 1, 2, 3, and 4

  3. Changes in post-meal measures of satiety

    Changes in post-meal measures of satiety across experimental conditions and intervention groups using 100-mm visual analog scales.

    Measured: Weeks 1, 2, 3, and 4

  4. Changes in post-meal ratings of meal characteristics

    Changes in post-meal ratings of meal characteristics across experimental conditions and between subject groups using 100-mm visual analog scales.

    Measured: Weeks 1, 2, 3, and 4

  5. Changes in ratings of food properties

    Changes in post-meal ratings of food properties across experimental conditions and subject groups using 100-mm visual analog scales.

    Measured: Weeks 1, 2, 3, and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study startOct 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03502096
Sponsor's protocol ID
PortionSize105
Other IDs
R01DK059853, NIFA Grant 2011-67001-30117
Status last verified
Apr 2018
First submitted
3 Apr 2018
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing To-Go container in people with Obesity and Eating Behavior, run by Penn State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the weight of food consumed (time frame: Weeks 1, 2, 3, and 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03502096.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.

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Portion Size and To-go Container on Dinner Intake | AzTrials