Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT05544461
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piloting a Web-based Personalised Nutrition App (eNutri) with UK University Students
Sponsor:
University of Reading
Organization:
Study Overview
Official Title:
Piloting a Web-based Personalised Nutrition App (eNutri) with UK University Students
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: