Feasibility Trial on Organic Fruit and Vegetable Consumption in Primary School-children
Condition: Obesity
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: organic; children; school; health promotion; fruits; vegetables