- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893213
Increasing Availability of Lower Energy Meals on Food Choice and Intake
May 11, 2022 updated by: Eric Robinson, University of Liverpool
Socioeconomic Position and the Impact of Increasing the Proportion of Lower Energy Foods Available on Supermarket Meal Choices and Consumption
This study will examine the effectiveness of a structural intervention (baseline proportion of lower energy ready meals vs increased proportion of lower energy ready meals) on calories (kcal) ordered and consumed.
The study will use a within-subjects design, meaning all participants will be exposed to both conditions (baseline vs increased lower energy meal menus).
The procedure will involve participants placing orders for supermarket ready meals, which are then delivered to their homes for their consumption.
This study will also investigate whether the effectiveness of the intervention varies, depending on socioeconomic position (SEP).
The primary hypothesis is that increasing proportion of lower energy options will decrease total kcal ordered and consumed, and that there will be no difference between higher and lower SEP.
To address the limited evidence on longer term impacts of dietary interventions on daily energy intake, the present study will also examine post-meal energy consumption up to midnight on the following day.
Finally, this study will explore the psychological processes that might underlie the effectiveness of the intervention among individuals with higher and lower SEP; namely, food choice motives, satiety responsiveness, plate clearing tendencies, and food waste concerns.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See attached protocol documents.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- 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
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- UK (United Kingdom) residents, aged 18 or over
- Fluent in English
- Have access to a phone/tablet/computer device which has access to Internet and a functioning camera
- Willing to consume two supermarket ready meals
- Have access to a functioning microwave and oven for the preparation of the ready meals
Exclusion Criteria:
- Taking part more than once
- Another member of the same household has participated in the study (Multiple members of the same household will not be allowed to take part)
- Current or historic diagnosed eating disorders
- Currently on any medication which affects appetite
- Any of the following dietary restrictions, intolerances, or allergies (Vegetarian, vegan, gluten-free, sugar-free, dairy/lactose-free, food allergy - such as milk, eggs, nut, wheat, fish, etc)
- History of severe childhood allergies, anaphylaxis or anaphylactic shock
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Baseline availability
Baseline availability of lower energy meal options
|
Menus provided differ in % of menu options that are higher vs. lower in energy
|
Experimental: Increased availability
Increased availability of lower energy meal options
|
Menus provided differ in % of menu options that are higher vs. lower in energy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total meal energy (kcal) ordered
Time Frame: 20 minutes (the time frame denotes time taken to complete the initial study questionnaire and make the food choices)
|
Calculated as the sum of the kcal content of the main and side ordered
|
20 minutes (the time frame denotes time taken to complete the initial study questionnaire and make the food choices)
|
Total meal energy (kcal) consumed
Time Frame: Once the food has been delivered, the time frame is up to 72 hours
|
Calculated as the sum of the kcals consumed from the main and side combined
|
Once the food has been delivered, the time frame is up to 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-meal intake (kcal)
Time Frame: Measured 24-30 hours after study meal is consumed
|
Calculated as total energy (kcal) consumed after the study meal until midnight on the following day (dietary recall).
|
Measured 24-30 hours after study meal is consumed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Robinson, PhD, Study Principal Investigator
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)
April 13, 2021
Primary Completion (Actual)
July 5, 2021
Study Completion (Actual)
July 5, 2021
Study Registration Dates
First Submitted
May 10, 2021
First Submitted That Met QC Criteria
May 17, 2021
First Posted (Actual)
May 19, 2021
Study Record Updates
Last Update Posted (Actual)
May 12, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 8710 Ready Meal Menu Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Shared on the Open Science Framework (OSF)
IPD Sharing Time Frame
On publication, indefinitely
IPD Sharing Access Criteria
Open website
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- 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. IPD will be made available when results are 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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