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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary school children attending the all-day school meals Exclusion Criteria: No exclusion criteria are applied

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>School-based intervention | Behavioral: Behavioral Intervention<br>* The intervention package will be consisted of: Introduction of organic fruits and vegetables (by replacing the conventional ones) in school lunch menus Signs in school areas about organic fruits and vegetables Workshops and interactive games for children Seminars for parents<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reported consumption frequency of fruit and vegetables (organic and conventional) in children | 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 | Number of participants recruited | 9 weeks | 
| Accrual losses | Number of participants declined/withdrawn to participate | 9 weeks | 
| Acceptability of the intervention by children (qualitative, proportions) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organic, children, school, health promotion, fruits, vegetables