Obesity Clinical Trial
— PRISHECOfficial title:
A School-based Intervention Programme to Promote Organic Fruit and Vegetable Consumption in Primary School-children: A Cluster-randomized Feasibility Trial (PRISHEC)
Verified date | July 2022 |
Source | Cyprus University of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Cyprus | Primary schools | Limassol |
Lead Sponsor | Collaborator |
---|---|
Cyprus University of Technology |
Cyprus,
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
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 |
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