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

Obesity Clinical Trial

— PRISHEC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184804
• Other study ID #: PRISHEC
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2021
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

Inclusion Criteria:

• Primary school children attending the all-day school meals

Exclusion Criteria:

• No exclusion criteria are applied

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Behavioral Intervention
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

Locations

Country	Name	City	State
Cyprus	Primary schools	Limassol

Sponsors (1)

Lead Sponsor	Collaborator
Cyprus University of Technology

Country where clinical trial is conducted

Cyprus, 

References & Publications (3)

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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accrual rates	Number of participants recruited	9 weeks
Secondary	Accrual losses	Number of participants declined/withdrawn to participate	9 weeks
Secondary	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
Secondary	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
Secondary	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