Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-02 @ 9:58 AM
Study NCT ID:
NCT06631469
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2024-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behaviour-focused Personalised Nutrition Intervention
Sponsor:
University College Dublin
Organization:
Study Overview
Official Title:
Behaviour-focused Personalised Nutrition Intervention to Promote Sustainable and Healthy Diets in University Students: a Feasibility Pilot Study
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:
The aim of this study is to test the efficacy, feasibility, and acceptability of a novel, behaviour-focused personalised nutrition intervention compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in university students.
Detailed Description:
Participants will be recruited from the University College Dublin (UCD) PLAN'EAT Living Lab (LL) Citizen Panel which will form a separate registration. The UCD PLAN'EAT LL is a series of studies designed to develop, implement, and evaluate strategies to support University students' transition towards a sustainable healthy diet. The UCD PLAN'EAT LL study will recruit up to n=500 healthy students (aged 18-30 years) attending UCD, Belfield Campus, to join the UCD PLAN'EAT LL Citizen Panel. Upon successful screening and completion of informed consent, participants will be invited to join the UCD PLAN'EAT LL Citizen Panel and complete initial baseline data collection measures (which will be detailed in a separate registration). Following completion of this baseline data collection, participants within the UCD PLAN'EAT LL Citizen Panel will be subsequently invited to participate in this study detailed below.
Participants within the UCD PLAN'EAT LL Citizen Panel will be invited to participate in a 4-week study. This study will aim to recruit n=40 participants within the UCD PLAN'EAT LL Citizen Panel. After successful screening and informed consent, participants will be randomised into two separate groups (n=20 control group; n=20 intervention group) receiving different types of personalised recommendations and strategies using decision tree algorithms to support them to consume a healthier and more sustainable diet. The control group will receive a personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) to meet their personalised dietary recommendations. The intervention group will receive the same as the control group, with the addition of receiving personalised behavioural support and strategies to help them meet their personalised dietary recommendations.
Baseline: Participants will be asked to complete a questionnaire including questions on demographics, health, dietary behaviours, and lifestyle and a dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of baseline measures, participants will be invited to attend a study visit in UCD. Participants will undergo a diet counselling session, where they will receive a personalised feedback report and advice from a nutritionist on how to achieve their goal of eating a more sustainable and healthy diet.
Midpoint: Participants will be contacted by a member of the research team via email or phone message to check their progression and to address any queries.
Endpoint: At the end of the 4-week study, participants will complete a diet-related questionnaire and a second dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of endpoint measures, retention rates (number of participants who complete endpoint measures / number of participants enrolled into the study x 100) and data completion rates (number of complete datasets for each outcome measure / number of participants enrolled ×100) will be calculated to assess study feasibility and acceptability.
Process Evaluation:
At the end of this study, all participants will be invited to complete a study evaluation questionnaire including feasibility, acceptability, and engagement measures. In addition, a subsample of participants will also be invited to participate in focus groups or one-to-one interviews to explore topics on study feasibility encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers/ enablers), study engagement, and suggestions for improvement. The focus groups or one-to-one interviews will be guided by the APEASE (Acceptability, Practicality, Effectiveness, Affordability, Side-effects, Equity) criteria.
Participants within the UCD PLAN'EAT LL Citizen Panel will be invited to participate in a 4-week study. This study will aim to recruit n=40 participants within the UCD PLAN'EAT LL Citizen Panel. After successful screening and informed consent, participants will be randomised into two separate groups (n=20 control group; n=20 intervention group) receiving different types of personalised recommendations and strategies using decision tree algorithms to support them to consume a healthier and more sustainable diet. The control group will receive a personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) to meet their personalised dietary recommendations. The intervention group will receive the same as the control group, with the addition of receiving personalised behavioural support and strategies to help them meet their personalised dietary recommendations.
Baseline: Participants will be asked to complete a questionnaire including questions on demographics, health, dietary behaviours, and lifestyle and a dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of baseline measures, participants will be invited to attend a study visit in UCD. Participants will undergo a diet counselling session, where they will receive a personalised feedback report and advice from a nutritionist on how to achieve their goal of eating a more sustainable and healthy diet.
Midpoint: Participants will be contacted by a member of the research team via email or phone message to check their progression and to address any queries.
Endpoint: At the end of the 4-week study, participants will complete a diet-related questionnaire and a second dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of endpoint measures, retention rates (number of participants who complete endpoint measures / number of participants enrolled into the study x 100) and data completion rates (number of complete datasets for each outcome measure / number of participants enrolled ×100) will be calculated to assess study feasibility and acceptability.
Process Evaluation:
At the end of this study, all participants will be invited to complete a study evaluation questionnaire including feasibility, acceptability, and engagement measures. In addition, a subsample of participants will also be invited to participate in focus groups or one-to-one interviews to explore topics on study feasibility encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers/ enablers), study engagement, and suggestions for improvement. The focus groups or one-to-one interviews will be guided by the APEASE (Acceptability, Practicality, Effectiveness, Affordability, Side-effects, Equity) criteria.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 101061023 | OTHER_GRANT | European Union Horizon Europe | View |