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

NCT04184804 | Completed

• 1 other identifier: PRISHEC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

organic; children; school; health promotion; fruits; vegetables

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Accrual rates

  9 weeks

• Accrual losses

  9 weeks

• Acceptability of the intervention by children (qualitative, proportions)

  9 weeks

• Change in number of servings of fruits and vegetables consumed

  9 weeks

• Change in reported consumption frequency of other food groups (meat and sweets/fats/oils groups) in children

  baseline, 9 weeks

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

School-based intervention

Behavioral: Behavioral Intervention

Control

NO INTERVENTION

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.

Interventions

Behavioral Intervention 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

Behavioral Intervention

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary school children attending the all-day school meals

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Primary schools

Limassol, Cyprus

Location

Related 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.

  PMID: 31483785 BACKGROUND

• 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.

  PMID: 25263832 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Konstantinos C Makris

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Konstantinos C. Makris, Associate Professor of Environmental Health

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 4, 2019
• Study Start: October 7, 2020
• Primary Completion: December 22, 2020
• Study Completion: December 31, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication of the study
• Access Criteria: Publicly available

Locations

CY (1)