Clinical trial NCT05544461: Piloting a Web-based Personalised Nutrition App (eNutri) with UK University Students
Official title: Piloting a Web-based Personalised Nutrition App (eNutri) with UK University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Diet, Healthy
Diet Modification
Keywords: Food frequency questionnaire
Nutrition
Dietary intake
Diet quality
Personalised nutrition
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diet quality score (DQS)
timeFrame: Baseline
measure: Diet quality score (DQS)
timeFrame: Week 4
Secondary outcomes:
measure: Weight
timeFrame: Pre-baseline
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: Week 4
measure: Height
timeFrame: Pre-baseline
measure: Height
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Pre-baseline
measure: Body mass index (BMI)
timeFrame: Baseline
measure: Body mass index (BMI)
timeFrame: Week 4
measure: eNutri Food Frequency Questionnaire (FFQ) dietary intake data
timeFrame: Pre-baseline (week -4)
measure: eNutri Food Frequency Questionnaire (FFQ) dietary intake data
timeFrame: Baseline
measure: eNutri Food Frequency Questionnaire (FFQ) dietary intake data
timeFrame: Week 4
measure: Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
timeFrame: Pre-baseline (Week -4)
measure: Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
timeFrame: Baseline
measure: Individual DQS component scores, food group intakes (e.g. vegetables, wholegrains) and nutrient intakes (e.g. saturated fat, sodium)
timeFrame: Week 4
measure: Usability of eNutri measured by the System Usability Scale (SUS)
timeFrame: Baseline
measure: Participants motivation and perceived ability to make dietary changes
timeFrame: Pre-baseline (Week -4)
measure: Participants motivation and perceived ability to make dietary changes
timeFrame: Baseline
measure: Participants motivation and perceived ability to make dietary changes
timeFrame: Week 4
measure: Participant feedback on the dietary advice received from eNutri
timeFrame: Week 4
measure: Feedback on the longer-term impact of the dietary advice received from eNutri
timeFrame: Week 12
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
city: Hatfield
country: United Kingdom
facility: University of Hertfordshire
state: Hertfordshire
Study officials:
affiliation: Hugh Sinclair Unit of Human Nutrition, University of Reading
name: Julie Lovegrove, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.