Feasibility Trial on Organic Fruit and Vegetable Consumption in Primary School-children (PRISHEC)
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|ClinicalTrials.gov Identifier: NCT04184804|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Behavioral Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: Behavioral Intervention
Behavioral: Behavioral Intervention
The intervention package will be consisted of:
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.
- 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.
- Accrual rates [ Time Frame: 18 weeks ]Number of participants recruited
- Accrual losses [ Time Frame: 18 weeks ]Number of participants declined/withdrawn to participate
- 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
- 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).
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 ClinicalTrials.gov identifier (NCT number): NCT04184804
|Contact: Konstantinos C Makrisemail@example.com|
|Contact: Corins Konstantinoufirstname.lastname@example.org|
|Principal Investigator:||Konstantinos C Makris||Cyprus University of Technology|