Status:
COMPLETED
RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children
Lead Sponsor:
Fudan University
Conditions:
Cognitive Function
Mood Disorders
Eligibility:
All Genders
7-11 years
Phase:
NA
Brief Summary
This project proposal outlines a randomized-controlled trial (RCT) aimed at evaluating the effects of increased fruit and vegetable (F\&V) intake on cognitive performance, attention, and mood in C...
Detailed Description
1. Intervention Method: The intervention will be implemented through the Healthy Breakfast Plan. 1. Healthy Breakfast Plan: During the 12-week intervention period, a pre-designed breakfast (includ...
Eligibility Criteria
Inclusion
- Children aged 7-11 years.
- Participants must be students enrolled in the selected schools participating in the study.
- Willingness and ability to consume the provided daily breakfast, including one piece of fruit and one piece of vegetable.
- Parents or legal guardians must provide informed consent for participation.
- Balanced preliminary investigation outcomes, especially regarding behaviors related to fruit and vegetable intake, socioeconomic status (SES), and absence of diagnosed diseases that could impact the study.
Exclusion
- Known allergies to any fruits, vegetables, or other foods provided in the intervention.
- Diagnosed psychological disorders, diabetes, gastrointestinal diseases, or other conditions that might interfere with cognitive assessments or the ability to participate in the study.
- Children currently participating in other dietary or cognitive intervention studies.
- Inability or unwillingness to comply with study protocols, including dietary requirements and sample collection.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT06560359
Start Date
September 11 2024
End Date
March 30 2025
Last Update
September 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
School of public health, Fudan University
Shanghai, Shanghai Municipality, China, 200032