Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560359
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
RCT on the Neurobehavioral Effects of Fruits and Vegetables in Shanghai Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neurobehavioral Effects of Increased Fruit and Vegetable Intake on Cognition Mood and Attention in 8-10-Year-Old Children from Shanghai a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project proposal outlines a randomized-controlled trial RCT aimed at evaluating the effects of increased fruit and vegetable FampV intake on cognitive performance attention and mood in Chinese children aged 8-10 years The increased FampV 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 WashoutFollow-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 FampV 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-MSMS
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 children39s 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
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-MSMS
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 children39s 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None