- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173376
SEP and the Impact of Portion Size on Daily Energy Intake
Socioeconomic Position and the Effect of Portion Size Reduction: a 1-day Dietary Behaviour Experimental Study
Reducing food portion size is a potential strategy to reduce energy intake. There is some evidence to suggest that individuals with lower socioeconomic position (SEP) intend to eat more from larger portions, suggesting that the effect of portion size on food intake might vary by SEP. However, no study has tested this by measuring actual food intake. This study examines whether reductions to the portion size of components of a main meal will reduce daily energy intake, and whether and how socioeconomic position (higher vs lower) moderates the portion size effect.
In a crossover experiment, participants will be served all meals in the lab on two separate days, with the portion size of main meal components at lunch and dinner manipulated (i.e. smaller on one day vs larger on the other day). All other foods offered are identical. Food intake from the portion-manipulated lunch and dinner, as well as all other meal components (breakfast, dessert, seconds, snacks) will be measured, and any additional food consumed by the participant will be measured using self-report, giving total daily energy intake (kcal).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Liverpool, United Kingdom, L69 7ZA
- University of Liverpool
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- UK (United Kingdom) residents, aged 18 or over
- Fluent in English
- willing to consume the test foods
- Self report liking of test foods
- BMI between 22.5 - 32.5kg2
Exclusion Criteria:
- taking medication which affects appetite
- currently pregnant
- history of eating disorders
- currently on a diet to lose weight
- food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
- participated in 2018 Mood Study
- currently participating in another study where meals are provided
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Larger portions
the main meal component (lunch/dinner) served to participants in the laboratory, reflecting 100% portion.
All other foods are identical across conditions (e.g.
sides, seconds, breakfast, dessert, snacks).
|
The intervention was administered via changing portion sizes of foods served to participants.
|
|
Experimental: Smaller portions
the main meal component (lunch/dinner) served to participants in the laboratory, reflecting 66% portion (i.e.
reduced portion size).
All other foods are identical across conditions (e.g.
sides, seconds, breakfast, dessert, snacks).
|
The intervention was administered via changing portion sizes of foods served to participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily energy intake
Time Frame: 24 hours after intervention administered
|
Total energy (kcal) consumed from breakfast, lunch, dinner, dessert, snackbox, and any self-reported additional foods.
|
24 hours after intervention administered
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite
Time Frame: 24 hours after intervention administered
|
Hunger and fullness sensations before and after laboratory-based meals (self-reported on visual analogue scales anchored at 0 'Not at all' and 100 'Extremely')
|
24 hours after intervention administered
|
|
Moderate-vigorous physical activity
Time Frame: 24 hours after intervention administered
|
Moderate-vigorous physical activity (recorded using wearable activity tracker), operationalised as active minutes/day (logged for activities with a metabolic equivalent of >/3)
|
24 hours after intervention administered
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Robinson, PhD, study principle investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 803194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Study Data/Documents
-
Study Protocol
Information comments: Protocol on the Open Science Framework (OSF)
- Statistical Analysis Plan
-
Individual Participant Data Set
Information comments: The study protocol and statistical analysis plan were pre-registered on the OSF prior to starting recruitment. Participant dataset (anonymised) will be made available when results are published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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