Clinical trial NCT06876272: Implementation and Evaluation of Nutrition Interventions
Official title: Implementation and Evaluation of Two Multicomponent Nutrition Interventions in Higher Education Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Participants
Nutrition Intervention
Higher Education Students
Keywords: Nutrition interventions
Healthy eating
Higher education students
Process evaluation
Effect evaluation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Stichting tegen Kanker
name: Vlaams Instituut Gezond Leven VZW
First posted: 2025-03-14
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study employs a non-randomized controlled trial with pre-, post-, and follow-up measurements.
Primary purpose: PREVENTION

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.

Detailed description: As part of a Foundation against Cancer project in collaboration with the Consumer Behavior Research Group (Department of Marketing, Innovation, and Organization, Ghent University), the Research Group on Physical Activity and Nutrition for Health and Performance (MOVE) (Department of Movement and Sport Sciences, VUB), the Health Promotion Research Group (Department of Public Health and Primary Care, Ghent University), and the Flemish Institute for Healthy Living, we aim to encourage students to adopt healthier and more sustainable eating habits.

This project focuses on the implementation and evaluation of two multi-component dietary interventions to promote healthy eating behaviors and prevent weight gain among Flemish higher education students.

Since unhealthy eating habits and obesity are the two main risk factors for cancer, it is crucial to encourage young people to make healthy lifestyle choices. The transition from secondary school to higher education is a critical period for weight gain and the neglect of dietary guidelines, and students are often overlooked in health promotion initiatives.

The goal of this study is to implement and evaluate two dietary interventions developed within this project at two institutions (a university and a college). Over a period of eight weeks, various actions will take place, both online and on campus. For this study, the campus environment will be strategically adjusted using a range of nudges to promote healthy (and sustainable) eating behavior among students. These subtle modifications are designed to positively influence students' choices without limiting their autonomy. Examples include redesigning dining areas, placing healthy and sustainable options more prominently, and making healthier choices more visually appealing.

Additionally, targeted actions will raise students' awareness of healthy (and sustainable) eating behaviors. These include information campaigns on social media and organizing information stands on campus. These stands will provide students with accessible opportunities to obtain information, ask questions, and sample sustainable and healthy products. The combination of physical modifications and various activities will create an engaging learning environment that contributes to awareness and behavioral change in students' dietary habits.

Moreover, sales data from the student restaurant will be collected throughout the intervention period (from February to May 2025). By monitoring these figures, changes in students' purchasing behavior can be analyzed. This will provide insights into the impact of nudges and awareness campaigns on the sales of healthy and sustainable food options.

The effectiveness of the intervention will be assessed through questionnaires administered to students before, immediately after, and several weeks after the intervention to capture changes in eating behavior and associated determinants. Two other campuses will serve as control groups for comparison.

In addition, a comprehensive process evaluation will be conducted using a process questionnaire for students and focus groups with both students and stakeholders. This will provide insights into the implementation and experiences of the intervention.

If successful, the program can be scaled up to other Flemish higher education institutions as part of a broader cancer prevention strategy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Higher education students:

  * Students who speak insufficient Dutch;
  * Students who are less than 18 years old.
* Adopters and implementers:

  * Persons who speak insufficient Dutch.

Primary outcomes:
measure: Nutrition behaviour
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Attitude
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Nutrition knowledge
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Self-efficacy
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Perceived food environment
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Intention
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Barriers
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Coocking skills
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Weight (in kg)
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
measure: Lenght (in cm)
timeFrame: 3 test occations: baseline, 10 weeks after baseline and 5 months after baseline.
Secondary outcomes:
measure: Fidelity
timeFrame: 10 weeks after baseline
measure: Dose delivered
timeFrame: 10 weeks after baseline
measure: Dose received
timeFrame: 10 weeks after baseline
measure: Reach
timeFrame: 10 weeks after baseline
measure: Recruitment
timeFrame: 10 weeks after baseline
measure: Context
timeFrame: 10 weeks after baseline
measure: Sales figures collection
timeFrame: From baseline through study completion, up to 9 months.
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: University college Leuven-Limburg: Campus Diepenbeek
state: Limburg
city: Leuven
country: Belgium
facility: University College Leuven-Limburg: Campus Proximus
state: Vlaams-Brabant
city: Antwerpen
country: Belgium
facility: University of Antwerp - Stadscampus
city: Antwerpen
country: Belgium
facility: University of Antwerp - Campus Drie Eiken
Study officials:
affiliation: Vrije Universiteit Brussel
name: Tom Deliens
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Wendy Van Lippevelde
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.