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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04184804
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Information provided by (Responsible Party):
Konstantinos Makris, Cyprus University of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Behavioral Intervention Not Applicable

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 COFA 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: A the beginning of the intervention (end of January 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 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 at the end of January 2020. Another ffq will be administered at the end of May 2020.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A School-based Intervention Programme to Promote Organic Fruit and Vegetable Consumption in Primary School-children: PRISHEC a Cluster-randomized Feasibility Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021

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.

Primary Outcome Measures :
  1. Change in reported consumption frequency of organic fruit and vegetables from children [ Time Frame: baseline, 18 weeks ]
    Self-reported consumption of foods based on a food frequency questionnaire.

Secondary Outcome Measures :
  1. Accrual rates [ Time Frame: 18 weeks ]
    Number of participants recruited

  2. Accrual losses [ Time Frame: 18 weeks ]
    Number of participants declined/withdrawn to participate

  3. Acceptability of the intervention by children (qualitative, proportions) [ Time Frame: 18 weeks ]
    Use of an evaluation questionnaire on intervention acceptability, which will be administered to parents at the end

  4. change in number of servings of fruits and vegetables consumed [ Time Frame: 18 weeks ]
    Each teacher that is in charge during lunch period records the number of fruits and salad servings consumed (photos of remaining fruits and salad).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy children attending any of the selected primary schools with ages of 6 to 12 years old, residing in Cyprus, at least for the last five years, planning on attending their currently registered school for at least the next five months.

Exclusion Criteria:

  • Children with chronic conditions (e.g. diabetes, asthma).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04184804

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Contact: Konstantinos C Makris 00357-25002398
Contact: Corins Konstantinou 00357-25002282

Sponsors and Collaborators
Cyprus University of Technology
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Principal Investigator: Konstantinos C Makris Cyprus University of Technology

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Responsible Party: Konstantinos Makris, Dr. Konstantinos Makris, Associate Professor of Environmental Health, Cyprus University of Technology Identifier: NCT04184804    
Other Study ID Numbers: PRISHEC
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon publication, the IPD will be available through the journal's website
Supporting Materials: Study Protocol
Time Frame: Upon publication of the study
Access Criteria: Publicly available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Konstantinos Makris, Cyprus University of Technology:
organic diet
health promotion