- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07385820
A Comparative Intervention Study on Strategies for Fruit Distribution and Awareness Campaigns in Schools
An Interventional Study Evaluating Two Different School Deployment Strategies, Testing the Effects of Onsite Awareness Raising on the Adoption of the Fruit-stands by Local Student Populations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is part of the Europe (EU) project "Improving and upscaling primary prevention of cancer by addressing childhood obesity through implementation research" (PREVENT), which aims to promote healthier dietary habits among students by improving access to fruits in school environments. The intervention is implemented in a set of participating schools, each assigned to one of the predefined strategies. The study examines whether providing fruit ad libitum during school hours influences students' snacking patterns, and whether an accompanying awareness campaign adds value beyond fruit availability alone.
In each participating school, fruit stands offering two types of fruit will be placed in central areas where students typically gather. Fruit will be available during periods when students have access to common spaces, and digital scales integrated into the stands will enable weight-based monitoring of fruit uptake. Designated school staff will photograph scale readings at the beginning, end, and one or more intermediate points during the day. These images will be processed using optical character recognition (OCR) to extract weight data and upload it to a secure backend system for automated monitoring of fruit distribution and potential food waste.
To evaluate students' eating behaviour and fruit consumption patterns, participating students will use a research mobile application to photograph their meals and snacks. Data collection takes place in three periods: (1) a baseline period prior to the introduction of fruit stands, (2) an early-intervention period immediately following the introduction of the stands, during which students continue to report all meals to capture short-term behavioural changes, and (3) a post-intervention period to assess sustained effects. The app records time and location metadata for each entry, allowing analysis of when and where food is consumed and how eating patterns change during the intervention.
The primary aim is to assess whether increased availability of free fruit influences students' snacking habits and whether the addition of an awareness campaign further enhances engagement with the fruit stands. Secondary aims include evaluating the feasibility of weight-based digital monitoring, characterising patterns of fruit uptake over the school day, and examining changes in students' overall eating behaviour across measurement periods. All data will be analysed at group level, and the study is considered minimal risk. Findings will support future scalable strategies for fruit distribution in school settings and contribute to broader evaluation of school-based dietary promotion initiatives.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 118 58
- Recruiting
- Internationella Engelska Gymnasiet Södermalm
-
Contact:
- Maria Fernanda Roca Rubio, PhD
- Phone Number: +46793599172
- Email: fernanda.roca@ki.se
-
Stockholm, Sweden, 168 48
- Recruiting
- Blackebergs gymnasium
-
Contact:
- Maria Fernanda Roca Rubio, PhD
- Phone Number: +46793599172
- Email: fernanda.roca@ki.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students enrolled in a Swedish school (elementary, middle, or high school)
- Ages 7-19 years
- Able to use a mobile phone to document meals and snacks
- Provided informed consent (with parental consent required for participants under 15 years old)
Exclusion Criteria:
- Presence of any clinically significant disease or condition that, in the opinion of the research team, may interfere with participation or influence study outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fruit stands only
Schools assigned to this arm receive fruit stands that provide free fruit during the school day.
No awareness or educational campaign is implemented.
Students report all their meals including fruits and snacks using the research mobile app before, during, and after the intervention
|
Free fruit is provided to students through fruit stands placed in central school areas.
Two fruit varieties are offered, and fruit uptake is monitored using digital scales integrated into the stands.
Students photograph school-provided fruit before eating it and annotate it as "school fruit" in the app, while also documenting all meals and snacks as part of the study protocol.
|
|
Experimental: Fruit stands + awareness campaign
Schools assigned to this arm receive fruit stands identical to the fruit-only arm, plus a school-based awareness campaign designed to promote healthy eating and encourage fruit consumption.
Students report all their meals including fruits and snacks using the research mobile app before, during, and after the intervention.
|
Free fruit is provided to students through fruit stands placed in central school areas.
Two fruit varieties are offered, and fruit uptake is monitored using digital scales integrated into the stands.
Students photograph school-provided fruit before eating it and annotate it as "school fruit" in the app, while also documenting all meals and snacks as part of the study protocol.
A school-based awareness campaign is delivered to promote healthy eating and encourage fruit consumption.
Activities may include posters, messaging, or informational content.
The campaign is implemented alongside the fruit stands to enhance student engagement with the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fruit consumption
Time Frame: From enrollment until the end of Post-measurements (10 weeks after enrollment)
|
Measured across baseline, early-intervention, and follow-up to evaluate whether fruit consumption differs between schools receiving fruit stands alone and those receiving fruit stands plus an awareness campaign.
|
From enrollment until the end of Post-measurements (10 weeks after enrollment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2024-07536-01
- 101104618 - PREVENT (Other Grant/Funding Number: European Commission: European Health and Digital Executive Agency (HADEA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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