Feel Good Study: Studying the relationship between fruits, vegetables, and children’s mental well-being.

Not Applicable

Completed

• Conditions: Mental Health; Cognitive Health; Mental Health - Studies of normal psychology, cognitive function and behaviour; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12623000533695
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Study Completion: 2024-03-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The main study population are children in school years 4-6 attending a primary school in Tamaki Makaurau, Auckland. Children will be recruited through classrooms, where primary school principals and teachers have consented for their classroom to participate. Any child in a participating classroom in school years 4-6 (approximate age range: 7 - 11 years old) can take part in the dietary intervention if they are able to provide written informed assent and complete outcome assessments.

Parents/caregivers and teachers of children in participating classrooms will also provide outcome data and therefore are considered as participants in this research. Any parent/caregiver of a child in a participating classroom can take part in the study if they are able to provide informed consent and complete outcome assessments. Any teacher of a participating classroom (i.e., a classroom where the principal has already provided consent) can take part in the study if they are able to provide informed consent, are willing for their classroom to participate in the planned intervention components and assessments during school hours, and are able to complete outcome assessments.

Exclusion Criteria

Individual children within the classroom may be excluded from data collection if they are unable to complete cognitive and psychosocial assessments (e.g., significant autism, unable to speak/understand English). Parents/caregivers may be excluded from data collection if they are unable to complete assessments (e.g., unable to speak/understand English or poor health literacy), though this does not exclude their child from data collection or participation in the study if the child themselves fulfils inclusion criteria.

There are no specific health or demographic criteria which would exclude teachers from taking part in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the Feel Good study, including participant recruitment (defined as number of participants that consented to participate from those who are eligible and were invited to participate). This data will be sourced from information provided by teachers (number of children in the classroom) and an audit of study screening and enrolment logs.[ Cumulative data will be assessed at Week 10 (end of intervention). ];Feasibility of the Feel Good study, including participant retention (defined as percentage of enrolled participants that completed data collection at baseline and the 10-week follow-up). This data will be sourced from an audit of the study REDCap database which includes study enrolment, withdrawal, and loss to follow-up logs.[ Cumulative data will be assessed at Week 10 (end of intervention)]