Diet, HealthyNCT04893213
Increasing Availability of Lower Energy Meals on Food Choice and Intake
A study testing Manipulation of availability of lower energy meal options in people with Diet, Healthy and Food Selection, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Food Selection, Obesity
- What is being tested?
- Manipulation of availability of lower energy meal options
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2021to 5 Jul 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Liverpool
Liverpool, Merseyside, L69 7ZA
About this study
Official title: 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.
Read the detailed description
See attached protocol documents.
- Conditions
- Diet, Healthy, Food Selection, Obesity, Eating Behavior
- Being tested
- Manipulation of availability of lower energy meal options
- Keywords
- availability, socio-economic position, food choice, eating behaviour
- Medical subject headings
- Food Preferences, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of availability of lower energy meal optionsOther
Menus provided differ in % of menu options that are higher vs. lower in energy
| Study group | Role | What they receive |
|---|---|---|
| Baseline availability | Active comparator | Baseline availability of lower energy meal options Receives: Other: Manipulation of availability of lower energy meal options |
| Increased availability | Experimental | Increased availability of lower energy meal options Receives: Other: Manipulation of availability of lower energy meal options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total meal energy (kcal) ordered
Calculated as the sum of the kcal content of the main and side ordered
Measured: 20 minutes (the time frame denotes time taken to complete the initial study questionnaire and make the food choices)
Total meal energy (kcal) consumed
Calculated as the sum of the kcals consumed from the main and side combined
Measured: Once the food has been delivered, the time frame is up to 72 hours
Secondary outcomes (1)
Post-meal intake (kcal)
Calculated as total energy (kcal) consumed after the study meal until midnight on the following day (dietary recall).
Measured: Measured 24-30 hours after study meal is consumed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start13 Apr 2021
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Robinson, University of Liverpool
- Investigators
- Eric Robinson, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893213
- Sponsor's protocol ID
- 8710 Ready Meal Menu Study
- Status last verified
- May 2022
- First submitted
- 10 May 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared on the Open Science Framework (OSF)
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Position and the Impact of Increasing the Proportion of Lower Energy Foods Available on Supermarket Meal Choices and Consumption
- ClinicalTrials.gov ID
- NCT04893213
- Acronym / sponsor ID
- 8710 Ready Meal Menu Study
- Conditions
- Diet, Healthy, Food Selection, Obesity, Eating Behavior
- Keywords
- availability, socio-economic position, food choice, eating behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 19 May 2021 (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.
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.
Detailed description
See attached protocol documents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline availability | Active comparator | Other: Manipulation of availability of lower energy meal optionsBaseline availability of lower energy meal options |
| Increased availability | Experimental | Other: Manipulation of availability of lower energy meal optionsIncreased availability of lower energy meal options |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Manipulation of availability of lower energy meal optionsMenus provided differ in % of menu options that are higher vs. lower in energy | Other | Baseline availability, Increased availability |
Primary outcome
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
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
1 secondary outcome
Post-meal intake (kcal)
Time frame: Measured 24-30 hours after study meal is consumed
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 12 May 2022.
- Individual participant dataSharing planned: Yes. Shared on the Open Science Framework (OSF)
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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.
Eric Robinson, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of availability of lower energy meal options in people with Diet, Healthy and Food Selection, 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 5 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 12 May 2022. 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?
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)). The study lists 2 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 12 May 2022.