Effect of kcal and PACE Labelling on Self-served Portion Size

November 2, 2020 updated by: Eric Robinson, University of Liverpool

Socioeconomic Position and the Effect of kcal Labelling and PACE Labelling on Self-served Portion Size

Participants will take part in an online survey. They will be asked to choose the amount of food they would like to eat based on pictures of 18 dishes sequentially displayed on the screen. They will be randomly allocated to four different groups: kcal labelling, PACE labelling (Physical Activity Calorie Equivalent: minutes to walk to burn off the calories), kcal and PACE labelling combined, no labelling, in a between subject design. The main outcome variable is the total "self-served" energy for each dish (in kcal).

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.

Detailed Description

See attached protocol documents.

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.
1800

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L69 7ZA
        • University of Liverpool

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • United Kingdom residents
  • Age ≥ 18
  • Fluent in English
  • Have access to a computer and Internet

Exclusion Criteria:

  • Have any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, diary or lactose free, food allergy)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Kcal labelling
Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal counter synchronised with the food amount changes (i.e., increasing/decreasing).
Behavioral: Kcal labelling
Real-time kcal counter synchronised with the food amount changes
Experimental: PACE labelling
Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes (i.e., increasing/decreasing) with 4 min being equivalent to 20 kcal.
Behavioral: PACE labelling
Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
Experimental: Kcal and PACE labelling
Participants allocated to this group will see on the screen the amount of food increasing or decreasing based on how many times they tap on the corresponding keys and a real-time kcal and PACE counters synchronised to the food amount changes (i.e., increasing/decreasing).
Behavioral: Kcal labelling
Real-time kcal counter synchronised with the food amount changes
Behavioral: PACE labelling
Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
No Intervention: No labelling
Participants allocated to this group will only see on the screen the amount of food increasing or decreasing based how many times they tap on the corresponding keys.

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
Total self-served energy (kcal)
Time Frame: 10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)
Energy content of the portion selected for each dish.
10 minutes (the time frame denotes time taken to perform the portion selection task and there is no follow up)

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
Kcal influence
Time Frame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
Whether kcal content influences the quantity of self-served food
3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
PACE influence
Time Frame: 3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)
Whether physical activity energy equivalent influences the quantity of self-served food.
3 minutes (the time frame denotes time taken to fill in the debriefing questionnaire and there is no follow up)

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.
University of Liverpool

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.
April 13, 2020

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.
April 13, 2020

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.
May 13, 2020

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 7, 2020

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 7, 2020

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 10, 2020

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.
November 3, 2020

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.
November 2, 2020

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.
November 1, 2020

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.
  • 803194 1B4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Shared on the Open Science Framework

IPD Sharing Time Frame

On publication, indefinitely

IPD Sharing Access Criteria

Open website

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Study Data/Documents

  1. Study Protocol
  2. Statistical Analysis Plan
  3. Informed Consent Form
  4. Individual Participant Data Set
    Information comments: When results will be published

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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