NCT06631469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

April 18, 2025

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 4, 2024

Last Update Submit

April 15, 2025

Conditions

Keywords

Sustainable dietPersonalised nutritionDietary behavioursUniversityStudents

Outcome Measures

Primary Outcomes (1)

  • Legume intake (grams per day)

    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.

    4 weeks

Secondary Outcomes (5)

  • Plant-based food intake (grams per day)

    4 weeks

  • Fruit intake (grams per day)

    4 weeks

  • Vegetable intake (grams per day)

    4 weeks

  • Meat intake (grams per day)

    4 weeks

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

    4 weeks

Other Outcomes (5)

  • Feasibility

    4 weeks

  • Feasibility

    4 weeks

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

    4 weeks

  • +2 more other outcomes

Study Arms (2)

Personalised behavioural sustainable and healthy dietary recommendations

EXPERIMENTAL

Personalised dietary plan, standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus personalised behavioural support and strategies aimed at meeting personalised dietary recommendations.

Behavioral: Personalised behavioural sustainable and healthy dietary recommendations

Personalised sustainable and healthy dietary recommendations

ACTIVE COMPARATOR

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

Behavioral: Personalised sustainable and healthy dietary recommendations

Interventions

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 behavioural sustainable and healthy dietary recommendations

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

Personalised sustainable and healthy dietary recommendations

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Related Publications (4)

  • 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: 38970665BACKGROUND
  • Macready AL, Fallaize R, Butler LT, Ellis JA, Kuznesof S, Frewer LJ, Celis-Morales C, Livingstone KM, Araujo-Soares V, Fischer AR, Stewart-Knox BJ, Mathers JC, Lovegrove JA. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 9;7(4):e87. doi: 10.2196/resprot.8703.

    PMID: 29631993BACKGROUND
  • Writing Group of the Nutrition Care Process/Standardized Language Committee. Nutrition care process and model part I: the 2008 update. J Am Diet Assoc. 2008 Jul;108(7):1113-7. doi: 10.1016/j.jada.2008.04.027. No abstract available.

    PMID: 18589014BACKGROUND
  • Rigby RR, Mitchell LJ, Hamilton K, Williams LT. The Use of Behavior Change Theories in Dietetics Practice in Primary Health Care: A Systematic Review of Randomized Controlled Trials. J Acad Nutr Diet. 2020 Jul;120(7):1172-1197. doi: 10.1016/j.jand.2020.03.019. Epub 2020 May 20.

    PMID: 32444328BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blinded parallel study
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

October 1, 2024

Primary Completion

December 29, 2024

Study Completion

February 26, 2025

Last Updated

April 18, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

At the beginning of the study, each participant will have a study code assigned to them. All data collected from the study will be stored using these unique study codes. A file will be set up which will be stored in a separate location to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be password-protected and only accessible to the research team/ named researchers on the project. Pseudonymised/ anonymised data will be shared with PLAN'EAT partners where appropriate.

Locations