- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06119295
Investigating the Effects of Altering Portion Size Reduction Awareness on Compensatory Eating Behaviour
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Liverpool, United Kingdom, L69 7ZA
- Recruiting
- University of Liverpool
-
Contact:
- Eric Robinson
- Phone Number: +44 (0)151 794 1187
- Email: Eric.Robinson@liverpool.ac.uk
-
Principal Investigator:
- Eric Robinson, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control Condition
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).
|
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.
|
Experimental: Reduce aware condition
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).
|
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.
|
Experimental: Reduced unaware condition
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate energy intake post-fixed lunch meal
Time Frame: Within 30 minutes after intervention administered
|
Amount of energy consumed from the lunch dessert
|
Within 30 minutes after intervention administered
|
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
|
Within 10 hours after intervention administered
|
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
|
Within 10 hours after intervention administered
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-lunch snack box intake
Time Frame: Within 4 hours after intervention administered
|
Amount of energy consumed from snack box consumed between lunch and dinner
|
Within 4 hours after intervention administered
|
Total intake of the ad libitum dinner meal
Time Frame: Within 4-5 hours after intervention administered
|
Amount of energy consumed from the dinner meal
|
Within 4-5 hours after intervention administered
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Portion size reduction study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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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