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Diet HabitNCT05544461

Piloting a Web-based Personalised Nutrition App (eNutri) with UK University Students

A study testing eNutri personalised nutrition advice in people with Diet Habit and Diet, Healthy, run by University of Reading at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

University students account for 50% of the UK young adult population and dietary assessment of this population is crucial in understanding the dietary changes that may occur as they transition to university and adulthood. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diet Habit, Diet, Healthy, Diet Modification
What is being tested?
eNutri personalised nutrition advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited Kingdom
Study dates
20 Sep 2022to 6 Jun 2023
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

  • Solely responsible for their own meal preparation and/or food purchases (includes catered and non-catered students)
  • Studying at the University of Reading or University of Hertfordshire, UK
  • Student in any year of study
  • 18 years or older
  • Able to read and understand written English without difficulties
  • Able to access eNutri using a suitable device (laptop, computer, tablet, or smartphone) with access to the internet
  • Have an active email address
  • Willing to complete online questionnaires and interact with eNutri on multiple occasions

Who cannot join

  • Students who are not studying full time in-person at university in the academic year 2022-2023 (e.g., part-time students, apprenticeship students or those on a work placement)
  • Students whose food choices are in part influenced/determined by others (e.g., students who live with parents, partner, or children during term time, including those who return home every weekend)
  • Those reliant on meals where there is limited choice/alternative options (e.g., Recipe boxes such as Gousto, Hello Fresh and Mindful Chef, or those who eat frozen meals brought from home); catered students can take part.
  • Pregnant, lactating or planning a pregnancy within the next 4 months
  • Food allergies to dairy, nuts/seeds and/or fish/shellfish
  • Medical conditions/treatments that have a considerable impact on an individual's diet/appetite on a day-to-day basis (e.g., severe gastrointestinal disorders)
Show all 14Show fewer
  • Have a current or previously diagnosed eating disorder
  • Usually eat on fewer than 2 occasions per day
  • Receiving dietary advice from a dietitian, nutritionist or medical professional or plan to do so within the next 4 months
  • Following a restrictive diet, such as a vegan diet, sport's nutrition diet, meal replacement shake/juice diet (e.g., SlimFast), intermittent fasting diet (e.g,. 5:2), very low carbohydrate diet (e.g., keto, Atkins) or any "fad"/"celebrity" diet, or plan to do so within the next 4 months; vegetarians can take part.
  • Following a weight-loss programme, such as Weight Watchers, Noom, LighterLife and Slimming World, or plan to do so within the next 3 months; those aiming to lose weight through general healthy eating and "cutting down" without following specialised weight loss advice can take part.
  • Taking weight-loss medication (prescribed or over the counter) or plan to do so within the next 3 months.
  • Visual and/or physical impairments that prevent an individual from interacting with visual elements on the screen on their device/using their device, such as clicking buttons/mouse or using the touch pad or viewing images.
  • Taking part in another nutrition-related research study.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • University of Hertfordshire

    Hatfield, Hertfordshire, AL10 9EU

  • University of Reading

    Reading, Berkshire, RG6 6DZ

Other trials in United Kingdom

About this study

University students account for 50% of the UK young adult population and dietary assessment of this population is crucial in understanding the dietary changes that may occur as they transition to university and adulthood. At this time, many students will leave home for the first time and become responsible for their dietary intake through food shopping and meal preparation. The limited body of evidence in this population group suggests that starting university may be associated with weight gain and the adoption of unhealthful dietary patterns however the extent of these changes may vary based on gender, cooking ability and grocery budget, to name a few. Furthermore, dietary guidance is not typically given to university students although evidence suggests that personalised nutrition advice based on an individual's habitual dietary intake could help to provide the education and support needed for individuals to adopt a healthier diet.

This student pilot study will test whether providing university students with eNutri personalised nutrition advice (intervention group) has a differential impact on diet quality in UK university students compared with those who do not receive any advice (control group) after a 4-week intervention period. 50 university students will use eNutri to record their dietary intake before being randomly allocated to the control or intervention group. After 4 weeks, both groups will repeat the eNutri food and drink questionnaire. Those in the intervention group will also be invited to complete a follow-up questionnaire after a further 8 weeks.

Read the detailed description

A minimum of 50 participants will be recruited from the University of Reading and University of Hertfordshire and will be asked to complete the eNutri food frequency questionnaire (FFQ) at pre-baseline (week -4) to capture their non-term time diet. 4 weeks later, the participants will be asked to repeat the questionnaire to capture their usual term time diet. At this time point, participants will be randomly allocated by eNutri to either the personalised nutrition (PN) intervention or control group:

  • PN intervention group: participants will receive web-based delivery of the eNutri PN advice tailored to their dietary intake, sex and certain dietary restrictions (such as whether they eat meat); PN advice will be unique to each participant.
  • Control group: participants will not receive any PN advice from eNutri.

The study will last for 16 weeks with a 4-week intervention period:

  • Week -4 (pre-baseline): participants will use eNutri to complete the eNutri FFQ, to provide self-reported anthropometric measurements (height and weight) and to answer questions on behaviour change, physical activity, computer proficiency, and usability of eNutri (via the system usability scale (SUS)).
  • Week 0 (baseline): participants will use eNutri to repeat the eNutri FFQ, to provide self-reported anthropometric measurements (height and weight) and demographic information, and to answer questions on behaviour change and physical activity. Those randomised to the PN group will also receive PN advice about their diet via eNutri and will complete a few short questions about which dietary targets they would like to focus on (if any) over the coming weeks to encourage behaviour change.
  • Weeks 1 \& 3: participants in the PN group only will receive interactive coaching emails to set new dietary goals, be reminded of their PN advice and receive tips and recipes to help them follow the advice.
  • Week 4 (end of study): participants in both groups will use eNutri to repeat the eNutri FFQ, provide self-reported weight, answer questions on physical activity and behaviour change, and provide feedback on the dietary advice received from eNutri (intervention group only).
  • Week 12 follow-up: participants in the intervention group will complete a short online questionnaire about the longer-term effects of the eNutri dietary advice received during the study.
Being tested
eNutri personalised nutrition advice
Keywords
Food frequency questionnaire, Nutrition, Dietary intake, Diet quality, Personalised nutrition
Medical subject headings
Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eNutri personalised nutrition adviceBehavioural

    eNutri is a web-based app that administers an FFQ and delivers PN advice to the user. The advice is generated from their responses in the FFQ and considers their sex and dietary restrictions (such as whether they eat meat) so the reports are unique to each participant. This report (referred to as a 'healthy eating report') will also include an interactive component, allowing the participant to reflect on the advice received and set personal healthy eating goals to motivate behaviour change. The messages presented in the report have been developed by the eNutri Team, including a registered dietitian and registered nutritionist and are in line with UK dietary guidelines (primarily the EatWell Guide).

Study groups in NCT05544461
Study groupRoleWhat they receive
Intervention groupExperimentalThose in the intervention group will receive eNutri PN advice after completing the eNutri FFQ at baseline only. At weeks 1 and 3 of the study, participants will also receive coaching emails which includes reminders of their PN advice, questions asking them to reflect on their goal progress (if any), and tips and recipes to help them follow the PN advice.
Receives: Behavioral: eNutri personalised nutrition advice
Control groupNo interventionThose in the control group will not receive any PN advice from eNutri and hence, will not receive any coaching emails. They will only record their diet using the eNutri FFQ.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diet quality score (DQS)

    An 11-item eNutri DQS will be automatically calculated by eNutri after completing the FFQ. The eNutri DQS was developed for Northern European adults and quantifies diet quality (i.e. the healthiness of a diet). It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines

    Measured: Baseline

  2. Diet quality score (DQS)

    An 11-item eNutri DQS will be automatically calculated by eNutri after completing the FFQ. The eNutri DQS was developed for Northern European adults and quantifies diet quality (i.e. the healthiness of a diet). It is composed of 11 food and nutrient components that are summed to give an overall score, where higher scores reflect the healthiest diets based on adherence to dietary guidelines

    Measured: Week 4

Secondary outcomes (20)
  1. Weight

    Self-reported measurement of weight

    Measured: Pre-baseline

  2. Weight

    Self-reported measurement of weight

    Measured: Baseline

  3. Weight

    Self-reported measurement of weight

    Measured: Week 4

  4. Height

    Self-reported measurement of height

    Measured: Pre-baseline

  5. Height

    Self-reported measurement of height

    Measured: Baseline

  6. Body mass index (BMI)

    Automatically calculated by eNutri after providing self-reported weight and height

    Measured: Pre-baseline

  7. Body mass index (BMI)

    Automatically calculated by eNutri after providing self-reported weight and height

    Measured: Baseline

  8. Body mass index (BMI)

    Automatically calculated by eNutri after providing self-reported weight and height

    Measured: Week 4

  9. eNutri Food Frequency Questionnaire (FFQ) dietary intake data

    eNutri includes a 157-item FFQ which participants will use to identify how often they typically ate/drank each item during the last 4 weeks (e.g. once a day, less than once a week, not in the last 4 weeks) then choose their typical portion size from a range of 7 photos/buttons. To increase the accuracy of the FFQ, some food/drink items have an extra question, such as the type of milk used on breakfast cereals/hot drinks or whether the food/drink item consumed was a reduced fat/sugar variety. The responses to the FFQ are used to automatically calculate the average intake in grams per day for each food item.

    Measured: Pre-baseline (week -4)

  10. eNutri Food Frequency Questionnaire (FFQ) dietary intake data

    eNutri includes a 157-item FFQ which participants will use to identify how often they typically ate/drank each item during the last 4 weeks (e.g. once a day, less than once a week, not in the last 4 weeks) then choose their typical portion size from a range of 7 photos/buttons. To increase the accuracy of the FFQ, some food/drink items have an extra question, such as the type of milk used on breakfast cereals/hot drinks or whether the food/drink item consumed was a reduced fat/sugar variety. The responses to the FFQ are used to automatically calculate the average intake in grams per day for each food item.

    Measured: Baseline

  11. eNutri Food Frequency Questionnaire (FFQ) dietary intake data

    eNutri includes a 157-item FFQ which participants will use to identify how often they typically ate/drank each item during the last 4 weeks (e.g. once a day, less than once a week, not in the last 4 weeks) then choose their typical portion size from a range of 7 photos/buttons. To increase the accuracy of the FFQ, some food/drink items have an extra question, such as the type of milk used on breakfast cereals/hot drinks or whether the food/drink item consumed was a reduced fat/sugar variety. The responses to the FFQ are used to automatically calculate the average intake in grams per day for each food item.

    Measured: Week 4

  12. Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)

    Recorded via eNutri FFQ

    Measured: Pre-baseline (Week -4)

  13. Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)

    Recorded via eNutri FFQ

    Measured: Baseline

  14. Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)

    Recorded via eNutri FFQ

    Measured: Week 4

  15. Usability of eNutri measured by the System Usability Scale (SUS)

    The SUS is a 10-item questionnaire with 5 response options that range from Strongly Agree to Strongly Disagree and is a reliable tool for measuring usability.

    Measured: Baseline

  16. Participants motivation and perceived ability to make dietary changes

    Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge

    Measured: Pre-baseline (Week -4)

  17. Participants motivation and perceived ability to make dietary changes

    Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge

    Measured: Baseline

  18. Participants motivation and perceived ability to make dietary changes

    Measured through a short psychology questionnaire covering ability, opportunity, motivation, and knowledge

    Measured: Week 4

  19. Participant feedback on the dietary advice received from eNutri

    Questionnaire covering how effective the dietary advice was at encouraging the participants to make healthy changes to their diet and whether they encountered any barriers (intervention group only).

    Measured: Week 4

  20. Feedback on the longer-term impact of the dietary advice received from eNutri

    A follow-up questionnaire provided at week 12 to determine whether there was a longer-term impact of the dietary advice received (intervention group only).

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start20 Sep 2022
  3. Primary completion11 Apr 2023
  4. Study completion6 Jun 2023

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544461
Sponsor's protocol ID
41/2022
Status last verified
Oct 2024
First submitted
13 Sep 2022
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We plan to share anonymised individual participant data that underlie results in publications in a public repository. Sharing of IPD will be in line with the confidentiality and consent agreements. This may include: * Sociodemographics * Anthropometrics * Dietary intake data

Publications

  • Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.

    PubMed 35468093

Questions about this trial

What is this clinical trial studying?

A study testing eNutri personalised nutrition advice in people with Diet Habit and Diet, Healthy, run by University of Reading at 2 sites 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 8 inclusion and 14 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Diet quality score (DQS) (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT05544461, which also lists 1 linked publication.

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 29 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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