Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631469
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Behaviour-focused Personalised Nutrition Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Behaviour-focused Personalised Nutrition Intervention to Promote Sustainable and Healthy Diets in University Students a Feasibility Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 PLANEAT Living Lab LL Citizen Panel which will form a separate registration The UCD PLANEAT 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 PLANEAT LL study will recruit up to n500 healthy students aged 18-30 years attending UCD Belfield Campus to join the UCD PLANEAT LL Citizen Panel Upon successful screening and completion of informed consent participants will be invited to join the UCD PLANEAT 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 PLANEAT LL Citizen Panel will be subsequently invited to participate in this study detailed below
Participants within the UCD PLANEAT LL Citizen Panel will be invited to participate in a 4-week study This study will aim to recruit n40 participants within the UCD PLANEAT LL Citizen Panel After successful screening and informed consent participants will be randomised into two separate groups n20 control group n20 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 eg 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 PLANEAT LL Citizen Panel will be invited to participate in a 4-week study This study will aim to recruit n40 participants within the UCD PLANEAT LL Citizen Panel After successful screening and informed consent participants will be randomised into two separate groups n20 control group n20 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 eg 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None