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Completed

NCT Number: NCT06631469

Behaviour-focused Personalised Nutrition Intervention

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Student Participants:

Inclusion criteria

  • Be a UCD student (aged 18-30 years) attending Belfield Campus.
  • Be an adult between the age of 18-30 years old, and in general good health.

Exclusion criteria

  • Do not attend UCD Belfield Campus.
  • Are under 18 years of age or over 30 years of age.
  • Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnosis include (but not limited to) cardiovascular disease, diabetes mellitus, cancers (within the past 5 years), etc.
  • Are pregnant, lactating or planning to become pregnant.
  • Are following a medically prescribed diet.
  • Are immunocompromised or have a suspected immunodeficiency.
  • Have a known food allergy.
  • Taking part in another diet-related research study that could interfere with the outcomes of this study
  • Consume ≥2 servings per day of legumes.

Treatment and study plan

Personalised behavioural sustainable and healthy dietary recommendations

Behavioral

Personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus the addition of receiving personalised behavioural support and strategies.

Personalised sustainable and healthy dietary recommendations

Behavioral

Personalised dietary plan and standardised behavioural support and strategies (based on previous personalised nutrition trials and usual care in dietetic practice).

Primary outcomes

  1. Legume intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Legume intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The primary outcome measure is the change in legume intake (g/ day) as a result of the intervention diet.

Secondary outcomes

  1. Plant-based food intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Plant-based food intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in plant-based food intake (g/ day) as a result of the intervention diet.

  2. Fruit intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Fruit intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in fruit intake (g/ day) as a result of the intervention diet.

  3. Vegetable intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Vegetable intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in vegetable intake (g/ day) as a result of the intervention diet.

  4. Meat intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Meat intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in meat intake (g/ day) as a result of the intervention diet.

  5. High fat, sugar, salt (HFSS) food intake (grams per day)

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. High fat, sugar, and salt food intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in high fat, sugar, and salt food intake (g/ day) as a result of the intervention diet.

Other outcomes

  1. Feasibility

    Time frame: 4 weeks

    Following completion of endpoint measures, retention rates (number of participants who complete endpoint measures / number of participants enrolled into the study x 100) will be calculated to assess study feasibility and acceptability.

  2. Feasibility

    Time frame: 4 weeks

    Following completion of endpoint measures, 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.

  3. Diet-related greenhouse gas emissions reported as kilograms of carbon dioxide equivalents per day

    Time frame: 4 weeks

    Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Diet-related greenhouse gas emissions will be estimated using food, nutrient and food-related greenhouse gas emission databases (measured as kilograms of carbon dioxide equivalents). The tertiary outcome measure is the change in diet-related greenhouse gas emissions (kgCO2-eq/day) as a result of the intervention diet.

  4. Self-reported behavioural automaticity index

    Time frame: 4 weeks

    Participants will record their self-reported behavioural automaticity at baseline and endpoint via a questionnaire. Each participant's score can range from 4-28 (with 4 indicating low behavioural automaticity and 28 indicating high behavioural automaticity). The quaternary outcome measure is the change in participants self-reported behavioural automaticity as a result of the intervention.

  5. Process Evaluation

    Time frame: 4 weeks

    At the end of this study, participants will complete an evaluation questionnaire. A subsample of participants will be invited to participate in focus groups or one-to-one interviews. Participants will evaluate study feasibility on topics encompassing: study experience, study acceptability, factors affecting participation rates (barriers and enablers), study engagement and suggestions for improvement. The quinary outcome is participants evaluation of this study.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • PLAN'EAT Consortium (https://planeat-project.eu/)

Registry information

Official study title

Behaviour-focused Personalised Nutrition Intervention to Promote Sustainable and Healthy Diets in University Students: a Feasibility Pilot Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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