Eating BehaviorNCT06119295
Investigating the Effects of Altering Portion Size Reduction Awareness on Compensatory Eating Behaviour
A study testing Portion size manipulation in people with Eating Behavior and Obesity, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Obesity
- What is being tested?
- Portion size manipulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to 16 May 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- United Kingdom (UK) residents able to visit laboratory on campus in Liverpool, aged ≥ 18
- Body Mass Index (BMI) between 18.5 and 32.5 kg/m2
- Proficiency in English language
- Self-report willingness to eat each of the test foods
Who cannot join
- Current medication use which affects appetite
- Pregnant
- Currently or previously diagnosed with an eating disorder
- Currently on a diet
- Have any food allergies or intolerances
- Are vegan
Trial locations and contacts
1 site in 1 country.
About this study
The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.
Read the detailed description
In the present study, all participants will participate in two sessions - the baseline session and the experimental session. In the baseline session, participants will be given ad libitum access to a lunch meal (followed by ad libitum access to dessert), and ad libitum access to a dinner meal (followed by ad libitum access to dessert). Then, after a washout period of between 1-6 weeks, participants will return to complete the experimental session, where they will be randomised to one of three conditions:
Condition 1 (control condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).
Condition 2 (reduced aware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session).
Condition 3 (reduced unaware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).
- Conditions
- Eating Behavior, Obesity
- Being tested
- Portion size manipulation
- 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 will be administered via changing portion sizes of foods served to participants. Depending on the condition participants are in, they will be served either a portion size which consists of the amount of food they consumed in the first test session, or a reduced portion size. Within these two reduced portion size conditions, one group of participants will be made aware that their portion size has been reduced, the other will not and instead will be told that this portion size is the same as the amount of food they consumed in the previous session.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Experimental | Participants will be served a lunch - this will be of a fixed portion - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session). Receives: Behavioral: Portion size manipulation |
| Reduce aware condition | Experimental | Participants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session). Receives: Behavioral: Portion size manipulation |
| Reduced unaware condition | Experimental | Participants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session). Receives: Behavioral: Portion size manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate energy intake post-fixed lunch meal
Amount of energy consumed from the lunch dessert
Measured: Within 30 minutes after intervention administered
Total delayed post-fixed lunch meal energy intake
Amount of energy consumed from the post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake
Measured: Within 10 hours after intervention administered
Total post-fixed lunch meal energy intake
Amount of energy consumed from the lunch dessert, post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake
Measured: Within 10 hours after intervention administered
Secondary outcomes (2)
Post-lunch snack box intake
Amount of energy consumed from snack box consumed between lunch and dinner
Measured: Within 4 hours after intervention administered
Total intake of the ad libitum dinner meal
Amount of energy consumed from the dinner meal
Measured: Within 4-5 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.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119295
- Sponsor's protocol ID
- Portion size reduction study
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised data set will be published on the open science framework for anyone to access.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Altering Portion Size Reduction Awareness on Compensatory Eating Behaviour
- ClinicalTrials.gov ID
- NCT06119295
- Acronym / sponsor ID
- Portion size reduction study
- Conditions
- Eating Behavior, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to investigate whether energy intake is reduced when participants consume a reduced portion size (15% compared to the 'control' portion), and also to see whether awareness of this reduction affects energy intake.
Detailed description
In the present study, all participants will participate in two sessions - the baseline session and the experimental session. In the baseline session, participants will be given ad libitum access to a lunch meal (followed by ad libitum access to dessert), and ad libitum access to a dinner meal (followed by ad libitum access to dessert). Then, after a washout period of between 1-6 weeks, participants will return to complete the experimental session, where they will be randomised to one of three conditions:
Condition 1 (control condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).
Condition 2 (reduced aware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session).
Condition 3 (reduced unaware condition): The same as the baseline condition except that the lunch will be of a fixed portion which participants must consume all of - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Experimental | Behavioral: Portion size manipulationParticipants will be served a lunch - this will be of a fixed portion - this portion size will be the same amount of food as was consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session). |
| Reduce aware condition | Experimental | Behavioral: Portion size manipulationParticipants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served has been reduced from the amount they consumed in the baseline session). |
| Reduced unaware condition | Experimental | Behavioral: Portion size manipulationParticipants will be served a lunch - this will be of a fixed portion - this portion size will be 15% less than the amount of food consumed in the ad libitum lunch meal in the baseline session (participants will be told that the amount of food served is the same as the amount they consumed in the baseline session). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- United Kingdom (UK) residents able to visit laboratory on campus in Liverpool, aged ≥ 18
- Body Mass Index (BMI) between 18.5 and 32.5 kg/m2
- Proficiency in English language
- Self-report willingness to eat each of the test foods
Key exclusion criteria (6 listed)
- Current medication use which affects appetite
- Pregnant
- Currently or previously diagnosed with an eating disorder
- Currently on a diet
- Have any food allergies or intolerances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portion size manipulationThe intervention will be administered via changing portion sizes of foods served to participants. Depending on the condition participants are in, they will be served either a portion size which consists of the amount of food they consumed in the first test session, or a reduced portion size. Within these two reduced portion size conditions, one group of participants will be made aware that their portion size has been reduced, the other will not and instead will be told that this portion size is the same as the amount of food they consumed in the previous session. | Behavioural | Control Condition, Reduce aware condition, Reduced unaware condition |
Primary outcome
Immediate energy intake post-fixed lunch meal
Time frame: Within 30 minutes after intervention administered
Amount of energy consumed from the lunch dessert
Total delayed post-fixed lunch meal energy intake
Time frame: Within 10 hours after intervention administered
Amount of energy consumed from the post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake
Total post-fixed lunch meal energy intake
Time frame: Within 10 hours after intervention administered
Amount of energy consumed from the lunch dessert, post-lunch snack box intake, dinner meal, dinner dessert, post-dinner snack box intake, additional energy intake
2 secondary outcomes
Post-lunch snack box intake
Time frame: Within 4 hours after intervention administered
Total intake of the ad libitum dinner meal
Time frame: Within 4-5 hours after intervention administered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. An anonymised data set will be published on the open science framework for anyone to access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portion size manipulation in people with Eating Behavior and Obesity, 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 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 Dec 2024. 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?
Immediate energy intake post-fixed lunch meal (time frame: Within 30 minutes after intervention administered). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.