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Diet, HealthyNCT05173376

SEP and the Impact of Portion Size on Daily Energy Intake

A study testing Portion size manipulation in people with Diet, Healthy and Eating Behavior, run by University of Liverpool at 1 site in United Kingdom.

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

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Diet, Healthy, Eating Behavior, Obesity
What is being tested?
Portion size manipulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited Kingdom
Study dates
25 Oct 2021to 7 Apr 2022
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Liverpool

    Liverpool, L69 7ZA

Other trials in United Kingdom

About this study

Official title: 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).

Read the detailed description

See attached protocol document.

Being tested
Portion size manipulation
Keywords
portion size, socio-economic position, eating behaviour
Medical subject headings
Feeding Behavior, Obesity

What participants receive

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

  • Portion size manipulationBehavioural

    The intervention was administered via changing portion sizes of foods served to participants.

Study groups in NCT05173376
Study groupRoleWhat they receive
Larger portionsExperimentalthe 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).
Receives: Behavioral: Portion size manipulation
Smaller portionsExperimentalthe 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).
Receives: Behavioral: Portion size manipulation

What is being measured

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

  1. Daily energy intake

    Total energy (kcal) consumed from breakfast, lunch, dinner, dessert, snackbox, and any self-reported additional foods.

    Measured: 24 hours after intervention administered

Secondary outcomes (2)
  1. Appetite

    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')

    Measured: 24 hours after intervention administered

  2. Moderate-vigorous physical activity

    Moderate-vigorous physical activity (recorded using wearable activity tracker), operationalised as active minutes/day (logged for activities with a metabolic equivalent of >/3)

    Measured: 24 hours after intervention administered

Timeline

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

  1. First posted29 Dec 2021
  2. Study start25 Oct 2021
  3. Primary completion7 Apr 2022
  4. Study completion7 Apr 2022

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
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173376
Sponsor's protocol ID
803194
Status last verified
Jan 2023
First submitted
14 Oct 2021
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study data (anonymised) will be shared on the Open Science Framework (OSF)

Publications

  • Langfield T, Clarke K, Marty L, Jones A, Robinson E. Socioeconomic position and the influence of food portion size on daily energy intake in adult females: two randomized controlled trials. Int J Behav Nutr Phys Act. 2023 Apr 27;20(1):53. doi: 10.1186/s12966-023-01453-x.

    PubMed 37101143

Questions about this trial

What is this clinical trial studying?

A study testing Portion size manipulation in people with Diet, Healthy and Eating Behavior, run by University of Liverpool at 1 site in United Kingdom.

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 6 inclusion and 7 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Daily energy intake (time frame: 24 hours after intervention administered). 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 NCT05173376, which also lists 1 linked publication.

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 10 Jan 2023.

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