RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children
- Conditions
- Attention-deficitCognitive FunctionMood Disorders
- Interventions
- Dietary Supplement: F&VDietary Supplement: No F&V
- Registration Number
- NCT06560359
- Lead Sponsor
- Fudan University
- 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 Chinese children aged 8-10 years. The increased F\&V intake will be achieved by providing a daily healthy breakfast including at least one piece of fruits and one piece of vegetables, as will as a weekly fruit box. The RCT includes a 2-week Lead-In term, 12 week Intervention term and 4 week Washout/Follow-Up term, targeting 280 children from the selected schools in Shanghai. The primary objective is to measure cognitive improvement using the Wechsler Intelligence Scale for Children (WISC-IV), while secondary outcomes will assess mood, attention, biomarkers, behavioral changes in dietary choices and the mechanism. The results of this trial may provide critical evidence on the benefits of F\&V consumption in children.
- Detailed Description
1. Intervention Method: The intervention will be implemented through two main plans: the Healthy Breakfast Plan and the Fruit Box Plan.
1. Healthy Breakfast Plan: During the 12-week intervention period, a pre-designed breakfast (including regular breakfast foods with fruits and vegetables) will be delivered daily to the homes of participating children.
2. Fruit Box Plan: Once a week, a fruit box will be delivered along with the breakfast to the homes of participating children, which includes fruits for both the children and their parents.
3. Important Considerations:
i) The Fruit Box Plan will only cover the intervention group and not the control group.
ii) The Breakfast Plan will include both the intervention group and the control group. The intervention group will receive the intervention meal (having fruits and vegetables), while the control group will receive a control meal (not having fruits and vegetables).
iii) The nutritional composition of both the Healthy Breakfast Plan and the Fruit Box Plan will be pre-designed by experts from the Department of Nutrition and Food Hygiene at Fudan University to ensure scientific accuracy.
2. Sample Size: The study will include a total of 280 children from the selected schools. Children will be randomly selected from 6 to 8 classes, resulting in approximately 140 children in the trial group and 140 in the control group. Cluster randomization will be applied at the classroom level, ensuring that all children within the same classroom are assigned to the same group. The sample size calculation is based on previous studies of literature using the Wechsler Intelligence Scale for Children (WISC-IV) to assess cognitive function. With assumptions based on existing literature, the study requires at least 150 participants to achieve statistical power. Accounting for a 20% attrition rate, a sample size of 280 is chosen to ensure robustness.
3. Exposure: Biomarkers, specifically vitamin C (ascorbic acid), will be measured from urine samples to monitor the intake of fruits and vegetables. The analysis will be conducted using reverse-phase high-performance liquid chromatography (HPLC) with UV detection or ultra-performance liquid chromatography coupled with mass spectrometry (UPLC-MS/MS).
4. Quality Control: To ensure accuracy in dietary intake reporting, the study will utilize food frequency questionnaires and 24-hour dietary records. These tools will help monitor and validate the children\'s fruit and vegetable consumption throughout the intervention period.
5. Ensuring Compliance with Fruit and Vegetable Intake:
1. Vitamin C Measurement: Urinary vitamin C levels will be measured to verify actual fruit and vegetable intake.
2. Questionnaires: Supervision of intake will be supported by questionnaires designed to track compliance and dietary habits.
3. Online Management Software: The study will use online management software to document each aspect of the project, allowing the research team and supervisors to monitor progress in real-time.
6. Data Collection and Assessments:
(a) Survey Questionnaires: i) Cognition: Evaluated by Wechsler Intelligence Scale for Children (WISC-IV). ii) Mood: Evaluated using the Profile of Mood States (POMS) questionnaire. iii) Attention: Evaluated by the Conners Parent Symptom Questionnaire (PSQ). iv) Physical Activity: Assessed using the International Physical Activity Questionnaire (IPAQ).
v) Dietary Habits and Preferences: Assessed by Food Frequency Questionnaire (FFQ), 24-hour dietary records, and the food preference questionnaires.
(b) Biological Specimen Collection: i) Urine sample: for measuring vitamin C. ii) Saliva sample: for measuring cortisol. Saliva sample will be collected from a subpopulation as a pilot study.
iii) Feces: for exploring the gut mechanisms that may modify the neurobehavior effects by increased intake of fruits and vegetables. Feces sample will be collected from a subpopulation as a pilot study.
(c) Physical Examinations: i) Measurements of height, weight, waist-to-hip ratio, and skinfold thickness will be taken to assess the overall physical health of participants.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
- Children aged 8-10 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trial Group F&V Participants in the Trial Group will receive a daily intervention consisting of a breakfast that includes one piece of fruits (e.g., an apple or a banana), vegetables (e.g., a carrot or a cucumber), and other regular diet. The fruit and vegetable will be provided as part of a standardized breakfast menu designed by nutrition experts. Participants will also receive an extra fruit box once a week at home. This intervention will be administered every morning, seven days a week, for a duration of 12 weeks. The goal is to increase the daily intake of fruits and vegetables among participants to assess the effects on cognitive performance, mood and attention. Control group No F&V Participants in the Control Group will maintain their regular breakfast without any additional interventions related to fruit and vegetable intake. No changes will be made to their daily breakfast routine. No fruit box will be delivered to the Control Group.
- Primary Outcome Measures
Name Time Method Change in Cognitive Performance the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). The primary outcome measure will assess the change in cognitive performance of children participating in the study. This will be evaluated using the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV), which is validated for use with Chinese children. The WISC-IV scale includes a range of cognitive tests that produce a Full Scale IQ score, with subtests for Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed. The scores range from 40 to 160, where higher scores indicate better cognitive performance. The measure will focus on the change in cognitive scores from baseline to post-intervention, as well as the retention of any cognitive changes after the washout period.
- Secondary Outcome Measures
Name Time Method Change in Mood States the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). This outcome will measure the change in mood states among participants, using the Profile of Mood States (POMS) questionnaire, which is validated for use in Chinese children. The POMS questionnaire assesses various aspects of mood, including tension, depression, anger, vigor, fatigue, and confusion. The scores for each mood state range from 0 to 4, with higher scores indicating a worse outcome in negative mood states (tension, depression, anger, fatigue, and confusion) and a better outcome in the positive mood state (vigor).
Change in Attention the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). This outcome will assess changes in attention among participants, as perceived by their parents, using the Conners' Parent Rating Scale (CPRS), which is also referred to in some contexts as the Conners Parent Symptom Questionnaire (PSQ). The CPRS is a validated tool used in the Chinese population to evaluate behavioral concerns, including attention. The scale includes items rated on a 4-point Likert scale, with scores ranging from 0 (Not at all true) to 3 (Very much true). Higher scores indicating worse attention outcomes, i.e., more attention-related problems.
Identification of Biomarkers in Saliva, Urine, and Feces Related to Cognition, Mood, and Attention the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). Vitamin C in urine will be served as a biomarker of F\&V intake. The biomarkers in saliva and feces will be served as the indicators of cognitive function, mood states, or attention levels. Samples of saliva and feces will be collected in a subpopulation as a pilot study. These biomarkers will be analyzed to understand the physiological changes associated with increased fruit and vegetable intake.
Behavioral Changes in Dietary Choices Influenced by Fruit and Vegetable Intake the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). This outcome will evaluate how increased intake of fruits and vegetables impacts dietary behavior, specifically the choices participants make regarding their overall diet. The assessment will be conducted using validated questionnaires that capture changes in dietary habits and preferences.
Investigation of Current Status and Barriers to Fruit and Vegetable Intake the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). This objective aims to assess the current level of fruit and vegetable intake among children and identify the barriers that limit their consumption. Factors such as nutrition literacy, food accessibility, and socioeconomic status will be explored to understand the challenges and opportunities for improving F\&V intake in this population.
Mechanistic Study of Cognitive Effects through Gut Microbiota the end of Week 2 (Baseline), Week 14 (end of intervention), and Week 18 (post-washout). This outcome will only be measured in a subpopulation as a pilot study, which will will investigate the mechanisms by which increased fruit and vegetable intake influences cognitive function. The study will assess changes in gut microbiota composition through stool samples.
Trial Locations
- Locations (1)
School of public health, Fudan University
🇨🇳Shanghai, Shanghai, China