Feasibility Trial on Organic Fruit and Vegetable Consumption in Primary School-children (PRISHEC)

July 19, 2022 updated by: Konstantinos Makris, Cyprus University of Technology

A School-based Intervention Programme to Promote Organic Fruit and Vegetable Consumption in Primary School-children: A Cluster-randomized Feasibility Trial (PRISHEC)

The aim of this trial is to examine the feasibility of a larger-scale intervention study (regional study in schools run by the Ministry of Education) to increase the consumption of fruits and vegetables in schools towards reducing percentages of childhood obesity prevalence rates by at least 0.5% every two years for all children, using an organic-based healthy eating intervention package for primary school children and their parents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pre-implementation phase: All necessary approvals (Bioethics, Ministry of Education) for the implementation of the study will be taken. Initial contacts with school directors will be done to obtain their approval.

Preparatory phase: Contact with the parents' union will be done, to explain the aim of the study and bring them in contact with interested organic companies in order to reach an agreement for the cost of providing organic fruits and vegetables in school lunch menus. Following the agreement, parents and children will be informed about the study through separate seminars for children and parents and a flyer that will be sent at home. Signed consent forms will be obtained. Teachers will also be taken on board and information pertaining to the overall scope and objectives of the study will be shared with them. This phase will also involve pre-testing of all the data collection tools. After pre-testing, necessary modifications will be carried out in the tools.

Intervention phase: At the beginning of the intervention (March 2020), a baseline questionnaire with demographic data and a food frequency questionnaire (FFQ) to record the children's diet habits will be administered to parents. Organic fruits and vegetables will be introduced at the school lunch menu and one workshop for children will be implemented per month. The workshops will include interactive games for children. Signs will be posted in various school areas. At the end of the intervention (end of May 2020), a seminar for parents will take place in order to discuss their children's impression of the program. FFQ and evaluation questionnaires (feedback on the intervention) will be administered to parents.

For the control group: No intervention (usual education). School directors are contacted and their approval is requested to conduct the study that aims to assess the eating habits of primary school children. The parents will be informed about the study with a flyer that will be sent at home through school and signed informed consents will be obtained. A baseline questionnaire with demographic data and an ffq will be administered to parents about their children in March 2020. Another ffq will be administered at the end of May 2020.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Limassol, Cyprus
        • Primary schools

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary school children attending the all-day school meals

Exclusion Criteria:

  • No exclusion criteria are applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Intervention
School-based intervention
Behavioral: Behavioral Intervention

The intervention package will be consisted of:

  1. Introduction of organic fruits and vegetables (by replacing the conventional ones) in school lunch menus
  2. Signs in school areas about organic fruits and vegetables
  3. Workshops and interactive games for children
  4. Seminars for parents
No Intervention: Control
Control. No intervention (usual education). The school does not receive any material and gets the information that they are part of a study on eating habits of primary school children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reported consumption frequency of fruit and vegetables (organic and conventional) in children
Time Frame: baseline, 9 weeks
Self-reported consumption of foods based on a food frequency questionnaire. This is based on the consumption frequency of food items for the last three months.
baseline, 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accrual rates
Time Frame: 9 weeks
Number of participants recruited
9 weeks
Accrual losses
Time Frame: 9 weeks
Number of participants declined/withdrawn to participate
9 weeks
Acceptability of the intervention by children (qualitative, proportions)
Time Frame: 9 weeks
Use of an evaluation questionnaire on intervention acceptability, which will be administered to parents at the end of the intervention. This includes 4 closed and 4 open-ended questions.
9 weeks
Change in number of servings of fruits and vegetables consumed
Time Frame: 9 weeks
Each teacher in charge during lunch period records the number of fruits and salad servings consumed (photos of non-consumed fruits and salad - 1 per week).
9 weeks
Change in reported consumption frequency of other food groups (meat and sweets/fats/oils groups) in children
Time Frame: baseline, 9 weeks
Self-reported consumption of foods based on a food frequency questionnaire. This is based on the consumption frequency of food items for the last three months.
baseline, 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Investigators

  • Principal Investigator: Konstantinos C Makris, Cyprus University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2020

Primary Completion (Actual)

December 22, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRISHEC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Upon publication, the IPD will be available through the journal's website

IPD Sharing Time Frame

Upon publication of the study

IPD Sharing Access Criteria

Publicly available

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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