Healthy LifestyleNCT05863078
The Menus of Change Health and Heart Benefits for University Students
An observational study of Healthy Lifestyle, run by University of Reading.
Trial summary
The goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants eating in the university halls following the Menus of Change diet will be selected and compared to participants living in the university halls but not following the Menus of Change and therefore eating outside the university dining halls
Who may be able to join
- Adults
- Home students living in university halls
- Undergraduates
- Can understand participant information sheet and willing to comply with the study design
Who cannot join
- International students
- postgraduates
- living outside the university halls
- participating in other studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Youmna Hussein, PharmD, MSc contact
About this study
Official title: The Menus of Change Health and Heart Benefits for University Students (The MOCHAHS Trial): a Cross-sectional Study
The goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. The main question it aims to answer is:
What are the effects of the menus of change on other vascular outcomes, namely blood pressure? What are the effects of the menus of change on other health markers?
Read the detailed description
The Menus of Change (MoC) is an example of behaviour change that was created by The Culinary Institute of America (CIA) and Harvard TH Chan School of Public Health. This initiative is based on a set of around 24 core principles, mainly promoting and serving 'healthy, sustainable, and delicious' food in restaurants and foodservice operations. The University of Reading has successfully implemented the MoC across the campus and in students' accommodations. However, MoC is not implemented across all campus halls.
To date, most of the studies performed in relation to the MoC had explored techniques to encourage students towards healthier, more sustainable diets. Very little research focuses on the associated health outcomes and hence the impact on health of the eating pattern laid out in the MoC principles.
Therefore, this project aims to investigate the health impact of the menu of change on university students, by comparing 2 groups: students eating in MoC catered halls, following the meal plan provided by the university food services, versus students who do not follow the menus of change meal plan. The primary aim will be to investigate the effect of the MoC on vascular outcomes, namely arterial stiffness, a particularly important tool in younger adults with low-moderate cardiovascular disease risk.
Secondary aims will be to investigate other vascular outcomes, namely blood pressure changes, as well as looking at other health markers, such as full blood count, lipid profile, sugar levels, liver and kidney function, and CVD related inflammatory markers. In addition, the study aims to look at the impact of the MoC on stress and anxiety levels and the differences in students' attainment between groups.
- Conditions
- Healthy Lifestyle
- Keywords
- Menus of Change, Arterial stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group following the Menus of Change diet | Not described | |
| Group not following the menus of Change diet | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Arterial stiffness will be measured using Mobil-O-Graph to assess the cardiovascular risk in participants
Measured: up to 2 weeks after completing a 3-day food diary
Secondary outcomes (7)
Full blood count
Full blood count levels will be compared between both groups
Measured: up to 2 weeks after completing a 3-day food diary
Lipid profile
Lipid profile levels will be compared between both groups
Measured: up to 2 weeks after completing a 3-day food diary
Glucose levels
by comparing levels between both groups
Measured: up to 2 weeks after completing a 3-day food diary
liver profile
comparing liver profile levels between both groups
Measured: up to 2 weeks after completing a 3-day food diary
Kidney profile
kidney profile levels to be compared between both groups
Measured: up to 2 weeks after completing a 3-day food diary
SCFA levels
short chain fatty acids levels to be compared between both groups
Measured: up to 2 weeks after completing a 3-day food diary
Cardiovascular disease related inflammatory biomarkers
Levels to be compared between both groups
Measured: up to 2 weeks after completing a 3-day food diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jan 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte E Mills, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863078
- Sponsor's protocol ID
- TBC
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Menus of Change Health and Heart Benefits for University Students (The MOCHAHS Trial): a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05863078
- Acronym / sponsor ID
- TBC
- Conditions
- Healthy Lifestyle
- Keywords
- Menus of Change, Arterial stiffness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 May 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 goal of this cross-sectional study is to investigate the health benefits of the Menus of Change in undergraduate university students, by comparing 2 groups: Students eating in the Menus of change catered halls, versus students eating outside the Menus of change meal plan. The main question it aims to answer is:
What are the effects of the menus of change on other vascular outcomes, namely blood pressure? What are the effects of the menus of change on other health markers?
Detailed description
The Menus of Change (MoC) is an example of behaviour change that was created by The Culinary Institute of America (CIA) and Harvard TH Chan School of Public Health. This initiative is based on a set of around 24 core principles, mainly promoting and serving 'healthy, sustainable, and delicious' food in restaurants and foodservice operations. The University of Reading has successfully implemented the MoC across the campus and in students' accommodations. However, MoC is not implemented across all campus halls.
To date, most of the studies performed in relation to the MoC had explored techniques to encourage students towards healthier, more sustainable diets. Very little research focuses on the associated health outcomes and hence the impact on health of the eating pattern laid out in the MoC principles.
Therefore, this project aims to investigate the health impact of the menu of change on university students, by comparing 2 groups: students eating in MoC catered halls, following the meal plan provided by the university food services, versus students who do not follow the menus of change meal plan. The primary aim will be to investigate the effect of the MoC on vascular outcomes, namely arterial stiffness, a particularly important tool in younger adults with low-moderate cardiovascular disease risk.
Secondary aims will be to investigate other vascular outcomes, namely blood pressure changes, as well as looking at other health markers, such as full blood count, lipid profile, sugar levels, liver and kidney function, and CVD related inflammatory markers. In addition, the study aims to look at the impact of the MoC on stress and anxiety levels and the differences in students' attainment between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group following the Menus of Change diet | – | – |
| Group not following the menus of Change diet | – | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants eating in the university halls following the Menus of Change diet will be selected and compared to participants living in the university halls but not following the Menus of Change and therefore eating outside the university dining halls
Key inclusion criteria (4 listed)
- Adults
- Home students living in university halls
- Undergraduates
- Can understand participant information sheet and willing to comply with the study design
Key exclusion criteria (4 listed)
- International students
- postgraduates
- living outside the university halls
- participating in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial stiffness
Time frame: up to 2 weeks after completing a 3-day food diary
Arterial stiffness will be measured using Mobil-O-Graph to assess the cardiovascular risk in participants
7 secondary outcomes
Full blood count
Time frame: up to 2 weeks after completing a 3-day food diary
Lipid profile
Time frame: up to 2 weeks after completing a 3-day food diary
Glucose levels
Time frame: up to 2 weeks after completing a 3-day food diary
liver profile
Time frame: up to 2 weeks after completing a 3-day food diary
Kidney profile
Time frame: up to 2 weeks after completing a 3-day food diary
SCFA levels
Time frame: up to 2 weeks after completing a 3-day food diary
Cardiovascular disease related inflammatory biomarkers
Time frame: up to 2 weeks after completing a 3-day food diary
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Youmna Hussein, PharmD, MSc contact
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Lifestyle, run by University of Reading.
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 4 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Mills, PhD (01183787108 ext. 7108, c.e.mills@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: up to 2 weeks after completing a 3-day food diary). 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 22 Nov 2024.