NCT05544461

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

September 13, 2022

Last Update Submit

October 25, 2024

Conditions

Keywords

Food frequency questionnaireNutritionDietary intakeDiet qualityPersonalised nutrition

Outcome Measures

Primary Outcomes (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

    Baseline

  • 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

    Week 4

Secondary Outcomes (20)

  • Weight

    Pre-baseline

  • Weight

    Baseline

  • Weight

    Week 4

  • Height

    Pre-baseline

  • Height

    Baseline

  • +15 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Those 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.

Behavioral: eNutri personalised nutrition advice

Control group

NO INTERVENTION

Those 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.

Interventions

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).

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

Location

University of Hertfordshire

Hatfield, Hertfordshire, AL10 9EU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35468093BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Julie Lovegrove, Professor

    Hugh Sinclair Unit of Human Nutrition, University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the study, the participants and researchers will be unblinded. Although the participants will not be explicitly told which group they are in, they will become aware of their group after completing the eNutri FFQ at baseline. Those randomised to the intervention group will receive their eNutri PN advice and those randomised to the control group will not receive any PN advice from eNutri and therefore know which group they have been allocated to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

September 20, 2022

Primary Completion

April 11, 2023

Study Completion

June 6, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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

Time Frame
No later than the time of first publication and available indefinitely thereafter.
Access Criteria
We plan for open access.

Locations