A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
60
NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes.
The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients.
Citruslabs
Santa Monica, California, United States
Change Mean Percentile Score in Double Trouble
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline and Month 6
IChange Mean Percentile Score in Feature Match
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline and Month 6
Change Mean Percentile Score in Grammatical Reasoning
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Digit Span
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Token Search
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
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Time frame: Baseline to Month 6
Increase in Height
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline, Month 2, Month 4, and Month 6
Changes in Weight
Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups.
Time frame: Baseline, Month 2, Month 4, and Month 6
Changes in Overall Health as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of the Child's Health in the Future.
This parameter was assessed using a parent-completed questionnaire, with the question "I expect my child will have a very healthy life". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Much worse," 5 = "Much Better"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Child's Energy Levels as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing High-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Limitations When Bending, Lifting, or Stooping.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Limitations During the Completion of Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children.
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Time frame: Monthly from Baseline to Month 6
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Time frame: Baseline to Month 6
Increase in Height - Nubest Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline to Month 6
Increase in Height - Placebo Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Time frame: Baseline to Month 6
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Time frame: Baseline to Month 6
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Time frame: Baseline to Month 6
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6.
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Time frame: Monthly from Baseline to Month 6
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Hide Description: This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Time frame: Monthly from Baseline to Month 6