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

NCT ID: NCT04184804

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-07
• Study Completion Date: 2021-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Behavioral Intervention

School-based intervention

Group Type: EXPERIMENTAL

Behavioral Intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Primary school children attending the all-day school meals

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cyprus University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Makris

Dr. Konstantinos C. Makris, Associate Professor of Environmental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos C Makris

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

Primary schools

Limassol, , Cyprus

Countries

Cyprus

References

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.

Reference Type: BACKGROUND

PMID: 31483785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25263832 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

PRISHEC

Identifier Type: -

Identifier Source: org_study_id