Novel Personalised Nutrition Intervention With Tailored Behavioural Support

NCT07417254 | Active Not Recruiting

• 2 other identifiers: LS-25-69-Gibney101061023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to test the efficacy of a novel personalised nutrition intervention with tailored behavioural support compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in young (18-30 years), healthy university students.

Conditions

Behavior Change Interventions; Behavior Change; Dietary Behaviour; Personalised Nutrition; Sustainable Healthy Diet; Behavior And Behavior Mechanism

Keywords

Personalised nutrition; Personalized nutrition; Behaviour change; Behavior change; Legumes; Sustainable healthy diets; Sustainable diets; Dietary behaviour; Dietary behavior; University students

Outcome Measures

Primary Outcomes (1)

• Legume intake (g/d)

  Legume intake (g/d) will be calculated as the mean intake across multiple days at each timepoint (i.e., baseline: mean (g/d) from 2-3 24-hour dietary recalls; endpoint: mean (g/d) from 2-3 24-hour dietary recalls). If \<2 recalls are available at endpoint, the endpoint's outcome is set to missing (per protocol). The primary outcome measure is endpoint legume intake (g/d). The primary estimand is the mean difference in legume intake (g/d) between groups at endpoint (4 weeks), adjusted for baseline legume intake (g/d). An exploratory analysis will be conducted to measure change in legume intake (g/d) between-groups at follow-up (8 weeks). The exploratory estimand will be the group × time interaction from a LMM at follow-up (8 weeks), and a between-group post-hoc test will be conducted where the group x time interaction is significant.

  4 weeks

Secondary Outcomes (4)

• Total fruit and vegetable intake (g/d)

  4 weeks

• Total meat intake (g/d)

  4 weeks

• Total discretionary food intake (g/d)

  4 weeks

• Composite dietary behaviour index (CDBI) (z-score units)

  4 weeks

Other Outcomes (24)

• Capability

  4 weeks

• Opportunity

  4 weeks

• Motivation

  4 weeks

Study Arms (2)

Personalised sustainable/healthy dietary recommendations with standardised and tailored support

EXPERIMENTAL

Intervention arm.

Behavioral: Personalised sustainable and healthy dietary recommendations with standardised and tailored behavioural support.

Personalised sustainable/healthy dietary recommendations with standardised support

ACTIVE COMPARATOR

Control arm.

Behavioral: Personalised sustainable and healthy dietary recommendations with standardised behavioural support.

Interventions

Personalised sustainable and healthy dietary recommendations with standardised and tailored behavioural support. BEHAVIORAL

Participants will receive a personalised dietary plan, standardised behavioural support (based on the standardised support provided in the pilot trial (https://clinicaltrials.gov/study/NCT06631469), which was based on previous personalised nutrition trials and usual care in dietetic practice), and tailored behavioural support to help participants to meet their personalised dietary recommendations.

Personalised sustainable/healthy dietary recommendations with standardised and tailored support

Personalised sustainable and healthy dietary recommendations with standardised behavioural support. BEHAVIORAL

Participants will receive a personalised dietary plan and standardised behavioural support (based on the standardised support provided in the pilot trial (https://clinicaltrials.gov/study/NCT06631469), which was based on previous personalised nutrition trials and usual care in dietetic practice) to help participants to meet their personalised dietary recommendations.

Personalised sustainable/healthy dietary recommendations with standardised support

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Do not attend UCD Belfield Campus.
• Are \<18 or \>30 years of age.
• Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnoses include (but are 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.

Sponsors & Collaborators

• University College Dublin: lead
• PLAN'EAT Consortium (https://planeat-project.eu/): collaborator

Study Sites (1)

University College Dublin, Belfield

Dublin, Dublin 4, Ireland

Location

Related Publications (1)

• Davies KP, Gibney ER, Leonard UM, Lindberg L, Woodside JV, Kiely ME, Nugent AP, Arranz E, Conway MC, McCarthy SN, O'Sullivan AM. Developing and testing personalised nutrition feedback for more sustainable healthy diets: the MyPlanetDiet randomised controlled trial protocol. Eur J Nutr. 2024 Oct;63(7):2681-2696. doi: 10.1007/s00394-024-03457-0. Epub 2024 Jul 6.

  PMID: 38970665 BACKGROUND

Related Links

• Pilot trial ClinicalTrials.gov registration.
• UCD PLAN'EAT Living Lab ClinicalTrials.gov registration.
• PLAN'EAT Project website.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: February 18, 2026
• Study Start: October 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)