Clinical trial NCT04184804: Feasibility Trial on Organic Fruit and Vegetable Consumption in Primary School-children
Official title: A School-based Intervention Programme to Promote Organic Fruit and Vegetable Consumption in Primary School-children: A Cluster-randomized Feasibility Trial (PRISHEC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: organic
children
school
health promotion
fruits
vegetables
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Primary school children attending the all-day school meals

Exclusion Criteria:

* No exclusion criteria are applied

Primary outcomes:
measure: Change in reported consumption frequency of fruit and vegetables (organic and conventional) in children
timeFrame: baseline, 9 weeks
Secondary outcomes:
measure: Accrual rates
timeFrame: 9 weeks
measure: Accrual losses
timeFrame: 9 weeks
measure: Acceptability of the intervention by children (qualitative, proportions)
timeFrame: 9 weeks
measure: Change in number of servings of fruits and vegetables consumed
timeFrame: 9 weeks
measure: Change in reported consumption frequency of other food groups (meat and sweets/fats/oils groups) in children
timeFrame: baseline, 9 weeks
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Primary schools
Study officials:
affiliation: Cyprus University of Technology
name: Konstantinos C Makris
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makris KC, Konstantinou C, Andrianou XD, Charisiadis P, Kyriacou A, Gribble MO, Christophi CA. A cluster-randomized crossover trial of organic diet impact on biomarkers of exposure to pesticides and biomarkers of oxidative stress/inflammation in primary school children. PLoS One. 2019 Sep 4;14(9):e0219420. doi: 10.1371/journal.pone.0219420. eCollection 2019.
citation: Savva SC, Kourides YA, Hadjigeorgiou C, Tornaritis MJ. Overweight and obesity prevalence and trends in children and adolescents in Cyprus 2000-2010. Obes Res Clin Pract. 2014 Sep-Oct;8(5):e426-34. doi: 10.1016/j.orcp.2013.11.005. Epub 2013 Dec 8.
citation: WHO-COSI, World Health Organisation - COSI report: http://www.euro.who.int/en/healthtopics/disease-prevention/nutrition/publications/2018/childhood-obesity-surveillance-initiative-cosifactsheet.-highlights-2015-17-2018