NCT06876272

Brief Summary

This project aims to implement and evaluate two multi-component dietary interventions focused on promoting healthy and sustainable eating behaviors and preventing weight gain among Flemish higher education students. These interventions will take place over a period of eight weeks and are specifically designed to support healthy lifestyle choices during the transition from secondary school to higher education, a critical period where unhealthy eating behaviors and weight gain are common. The interventions will be conducted at a university and a college, utilizing nudges in student restaurants, social media campaigns via Instagram, and workshops to encourage healthy and sustainable eating habits. Effectiveness will be measured using questionnaires administered at three points in time: before the intervention (baseline), immediately after the intervention (post-intervention), and five months later (follow-up). Two other campuses will serve as a control group to compare results. In addition to assessing effectiveness, a process evaluation will also be conducted. This will involve focus groups with students and stakeholders, as well as a process questionnaire, to gain insights into the implementation of the interventions and the experiences of those involved. If the interventions prove successful, they may be scaled up to other Flemish institutions as part of a broader strategy for cancer prevention.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
653

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

December 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

Same day

First QC Date

December 5, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Nutrition interventionsHealthy eatingHigher education studentsProcess evaluationEffect evaluation

Outcome Measures

Primary Outcomes (10)

  • Nutrition behaviour

    Measured using an online questionnaire specifically developed for this study. This section of the questionnaire incorporated a modified version of the Food Frequency Questionnaire (FFQ), adapted from the Health Behaviour in School-aged Children (HBSC) survey for high school students. The FFQ evaluates dietary intake by measuring the consumption of both healthy foods (e.g., vegetables, fruits) and unhealthy foods (e.g., sugary drinks, fast food). Responses were recorded on an ordinal frequency scale, ranging from "never" to "more than three times per day."

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Attitude

    Measured using an online questionnaire specifically developed for this study. This section incorporated adapted questions from the REWARD study, as well as the EAT 2 and EAT 3 surveys. Attitudes toward healthy eating were measured using a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree."

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Nutrition knowledge

    Measured using an online questionnaire specifically developed for this study. This section incorporated questions from the General Nutrition Knowledge Questionnaire (GNKQ) and study-specific questions related to the intervention (e.g., daily water intake recommendations). Nutrition knowledge was evaluated through multiple-choice questions.

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Self-efficacy

    Measured using an online questionnaire specifically developed for this study. This section of the questionnaire incorporates adapted items from the REWARD study. Participants rated their confidence in making healthy and sustainable food choices using a 5-point Likert scale, ranging from "very difficult" to "very easy."

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Perceived food environment

    Measured using an online questionnaire specifically developed for this study. This section of the questionnaire incorporated questions adapted to students' contexts from the Perceived Food Environment Questionnaire. Responses were recorded on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree."

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Intention

    Measured using an online questionnaire specifically developed for this study. This section of the questionnaire incorporated a question derived from the Transtheoretical Model to assess participants' intention, based on their readiness to change their eating habits.

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Barriers

    Measured using an online questionnaire specifically developed for this study. This section of the questionnaire incorporated adapted questions from the REWARD study to assess perceived barriers to eating healthy and sustainable. Responses were recorded on a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree."

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Coocking skills

    Measured using an online questionnaire developed specifically for this study. This section included the food literacy behaviours tool from Begley to assess participants' cooking skills. Responses were measured using a 5-point Likert scale, ranging from "never" to "always".

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Weight (in kg)

    Measured using an online questionnaire specifically developed for this study.

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

  • Lenght (in cm)

    Measured using an online questionnaire specifically developed for this study.

    3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.

Secondary Outcomes (7)

  • Fidelity

    10 weeks after baseline

  • Dose delivered

    10 weeks after baseline

  • Dose received

    10 weeks after baseline

  • Reach

    10 weeks after baseline

  • Recruitment

    10 weeks after baseline

  • +2 more secondary outcomes

Study Arms (2)

Nutrition intervention

EXPERIMENTAL

This arm involves a multi-component intervention designed to promote healthy eating behaviors and prevent weight gain among higher education students. The intervention includes the following components: Social Media Campaign: A series of targeted posts, stories, polls and video's across Instagram aimed at raising awareness of healthy eating habits and the importance of maintaining a balanced diet. Nudges: Behavioral cues placed in strategic locations, such as the student cafeteria, to encourage healthier food choices. These nudges aim to subtly influence students' eating behavior without restricting their freedom of choice. Workshops: Interactive workshops that provide students with practical tools and knowledge to make healthier dietary choices, understand nutrition labels, and adopt healthy eating habits.

Behavioral: Healthy eating promoting programme

Control

NO INTERVENTION

This group receives no intervention.

Interventions

It is a comprehensive, multi-component intervention tailored specifically for higher education students. Unlike many traditional health programs, this intervention uniquely combines the use of social media campaigns, behavioral nudges in student cafeterias, and interactive boost workshops.

Nutrition intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Higher education students:
  • Participant is willing and able to give informed consent for par-ticipation in the study;
  • Male, female or X, aged 18-24 years;
  • Healthy higher education students from institution X or campus Y.
  • Adopters and implementers:
  • Persons who are involved in the design, implementation, daily operations or management of the nutrition intervention.
  • Persons who have knowledge of the specific goals of the nutrition intervention.

You may not qualify if:

  • Higher education students:
  • Students who speak insufficient Dutch;
  • Students who are less than 18 years old.
  • Adopters and implementers:
  • Persons who speak insufficient Dutch.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Antwerp - Stadscampus

Antwerp, Antwerpen, 2000, Belgium

RECRUITING

University of Antwerp - Campus Drie Eiken

Antwerp, Antwerpen, 2610, Belgium

RECRUITING

University college Leuven-Limburg: Campus Diepenbeek

Diepenbeek, Limburg, 3590, Belgium

RECRUITING

University College Leuven-Limburg: Campus Proximus

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (11)

  • Saunders RP, Evans MH, Joshi P. Developing a process-evaluation plan for assessing health promotion program implementation: a how-to guide. Health Promot Pract. 2005 Apr;6(2):134-47. doi: 10.1177/1524839904273387.

    PMID: 15855283BACKGROUND
  • Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

    PMID: 10170434BACKGROUND
  • Carbonneau E, Robitaille J, Lamarche B, Corneau L, Lemieux S. Development and validation of the Perceived Food Environment Questionnaire in a French-Canadian population. Public Health Nutr. 2017 Aug;20(11):1914-1920. doi: 10.1017/S1368980017000581. Epub 2017 Apr 3.

    PMID: 28367784BACKGROUND
  • Parmenter K, Wardle J. Development of a general nutrition knowledge questionnaire for adults. Eur J Clin Nutr. 1999 Apr;53(4):298-308. doi: 10.1038/sj.ejcn.1600726.

    PMID: 10334656BACKGROUND
  • Robinson-O'Brien R, Larson N, Neumark-Sztainer D, Hannan P, Story M. Characteristics and dietary patterns of adolescents who value eating locally grown, organic, nongenetically engineered, and nonprocessed food. J Nutr Educ Behav. 2009 Jan-Feb;41(1):11-8. doi: 10.1016/j.jneb.2008.03.007.

    PMID: 19161915BACKGROUND
  • Inchley J, Currie D, Samdal O, Jåstad A, Cosma A & Nic Gabhainn S, editors. Health Behaviour in School-aged Children (HBSC) Study Protocol: background, methodology and mandatory items for the 2021/22 survey. Glasgow: MRC/CSO Social and Public Health Sciences Unit, University of Glasgow; 2023

    BACKGROUND
  • De Cock N, Van Lippevelde W, Goossens L, De Clercq B, Vangeel J, Lachat C, Beullens K, Huybregts L, Vervoort L, Eggermont S, Maes L, Braet C, Deforche B, Kolsteren P, Van Camp J. Sensitivity to reward and adolescents' unhealthy snacking and drinking behavior: the role of hedonic eating styles and availability. Int J Behav Nutr Phys Act. 2016 Feb 9;13:17. doi: 10.1186/s12966-016-0341-6.

    PMID: 26861539BACKGROUND
  • Deliens T, Verhoeven H, De Bourdeaudhuij I, Huybrechts I, Mullie P, Clarys P, Deforche B. Factors associated with fruit and vegetable and total fat intake in university students: A cross-sectional explanatory study. Nutr Diet. 2018 Apr;75(2):151-158. doi: 10.1111/1747-0080.12399. Epub 2018 Jan 4.

    PMID: 29314564BACKGROUND
  • Deliens T, Van Crombruggen R, Verbruggen S, De Bourdeaudhuij I, Deforche B, Clarys P. Dietary interventions among university students: A systematic review. Appetite. 2016 Oct 1;105:14-26. doi: 10.1016/j.appet.2016.05.003. Epub 2016 May 13.

    PMID: 27181201BACKGROUND
  • Deliens T, Clarys P, De Bourdeaudhuij I, Deforche B. Correlates of University Students' Soft and Energy Drink Consumption According to Gender and Residency. Nutrients. 2015 Aug 6;7(8):6550-66. doi: 10.3390/nu7085298.

    PMID: 26258790BACKGROUND
  • Deliens T, Clarys P, De Bourdeaudhuij I, Deforche B. Determinants of eating behaviour in university students: a qualitative study using focus group discussions. BMC Public Health. 2014 Jan 18;14:53. doi: 10.1186/1471-2458-14-53.

    PMID: 24438555BACKGROUND

Study Officials

  • Tom Deliens

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR
  • Wendy Van Lippevelde

    University Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: This study employs a non-randomized controlled trial with pre-, post-, and follow-up measurements.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific collaborator

Study Record Dates

First Submitted

December 5, 2024

First Posted

March 14, 2025

Study Start

February 17, 2025

Primary Completion

February 17, 2025

Study Completion

December 31, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations