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Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD (Nutrilect)

Primary Purpose

Nutrition Disorder, Child

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrilect
Sponsored by
Silviya Pavlova Nikolova, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Nutrition Disorder, Child

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD. Expressed willingness to participate in the study. Availability for the entire duration of the study. Exclusion Criteria: Children with acute medical conditions or comorbidities that may significantly disrupt study assessments. Any severe infections within the last 10 days prior to the study. Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome. Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention. Children who have been part of any major dietary or nutritional interventions in the last three months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    No Intervention

    Experimental

    No Intervention

    Arm Label

    CP with recommended diet

    CP with a standard of care nutritional menu

    ASD with recommended diet

    ASD with a standard of care nutritional menu

    Arm Description

    CP children that will follow a recommended menu

    Children with CP that will not be advised on a specific menu

    Children with ASD that will not be advised on a specific menu

    Children with ASD that will not be advised on a specific menu

    Outcomes

    Primary Outcome Measures

    bedridden days monthsmean duration of bedridden days over six months
    mean duration of bedridden days

    Secondary Outcome Measures

    Weight-for-Age Z-Score
    The Weight-for-Age Z-Score serves as a secondary outcome measure in the study, primarily focusing on assessing changes in the study participants' weight status. Data collection involves anthropometric assessments and the utilization of reference growth charts, specifically the World Health Organization (WHO) reference charts, to record participants' weight relative to their age. This measurement employs the Z-score as the unit of measure, quantifying deviations in weight from the baseline. A positive Z-score indicates above-average weight for a given age group, while a negative Z-score indicates below-average weight, providing a valuable indicator of participants' nutritional status and growth trends over time.
    Height-for-Age Z-Score
    The Height-for-Age Z-Score is a secondary outcome measure focused on evaluating changes in the study participants' height status. It involves anthropometric assessments and the use of WHO reference growth charts to record participants' height in relation to their age. The Z-score is the unit of measure, allowing for the quantification of height changes relative to the baseline. A positive Z-score indicates above-average height for the age group, while a negative Z-score indicates below-average height, offering a valuable indicator of participants' growth patterns and nutritional well-being over time.
    BMI-for-Age Z-Score
    The secondary outcome measure, BMI-for-age Z-Score, assesses changes in the study participants' Body Mass Index (BMI) in relation to their age. This measurement relies on deriving BMI from weight and height measurements, with comparisons made using reference growth charts provided by the World Health Organization (WHO). The Z-score is employed as the unit of measure, enabling the quantification of BMI changes relative to the baseline. A positive Z-score signifies an above-average BMI for the age group, whereas a negative Z-score indicates a below-average BMI, serving as an essential metric for tracking variations in participants' nutritional status and body composition throughout the study.
    Number of social interactions per week with non-family members
    The 'Number of Social Interactions per Week with Non-Family Members' is a quantitative measure that assesses the child's weekly engagement in social interactions with individuals outside their immediate family circle. It involves tracking and recording the frequency of diverse social exchanges, such as conversations, playdates, school-related interactions, and community engagements over a one-week period. This measure is instrumental in evaluating the child's social participation, integration into broader social networks, and overall quality of life. A higher number of interactions typically indicates greater social engagement and integration, while a lower number may signal reduced social participation, highlighting areas that require attention for the child's holistic development.
    Total Number of New Spoken Words per Month
    Total Number of New Spoken Words per Month is a quantitative measure employed to evaluate a child's language development and communication skills over a one-month period. This measure involves systematically counting and recording the distinct words that the child effectively uses and articulates in conversations, interactions, or observations during the course of each month. Specifically, it focuses on identifying and tallying newly acquired words within the given timeframe.A higher number of newly spoken words typically indicates positive language development, reflecting effective vocabulary expansion and improved communication skills. A threshold of one new word per month is established as a meaningful indicator of progress.
    Total Days of School or Kindergarten Attendance per month
    Total Days of School or Kindergarten Attendance per Month is a quantitative measure used to precisely assess a child's consistent participation in a formal educational setting, such as school or kindergarten, within the span of one month.A higher total number of days attended per month reflects more consistent participation in educational settings, indicating a stronger connection to learning opportunities and educational routines. Conversely, a lower total may indicate irregular attendance or potential challenges that require attention.
    Number of Leisure Activities per Month
    The 'Number of Leisure Activities per Month' is a quantitative measure used to assess children's level of engagement in leisure and recreational pursuits over a one-month period. This measure involves systematically counting and documenting the quantity of diverse leisure activities, hobbies, or pastimes that the individual participates in during the designated month. Leisure activities encompass a wide range of choices, such as hobbies, sports, cultural events, or entertainment, selected for relaxation, enjoyment, and personal enrichment. A higher count of leisure activities often indicates a more diversified and active leisure lifestyle, potentially contributing to an enhanced overall quality of life, while a lower count may suggest limited engagement in leisure pursuits, highlighting opportunities for greater leisure satisfaction.

    Full Information

    First Posted
    September 16, 2023
    Last Updated
    October 1, 2023
    Sponsor
    Silviya Pavlova Nikolova, PhD
    Collaborators
    European Union
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06065904
    Brief Title
    Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD
    Acronym
    Nutrilect
    Official Title
    Exploring the Efficacy of a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD: A Randomized Controlled Trial at a Single Center
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 23, 2024 (Anticipated)
    Study Completion Date
    July 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Silviya Pavlova Nikolova, PhD
    Collaborators
    European Union

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The study is a prospective, single-center, randomized controlled trial that will be conducted at the Medical University of Varna. This setting offers access to a wealth of clinical expertise in managing CP and ASD and a rich tradition of conducting robust nutritional interventions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Disorder, Child

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CP with recommended diet
    Arm Type
    Experimental
    Arm Description
    CP children that will follow a recommended menu
    Arm Title
    CP with a standard of care nutritional menu
    Arm Type
    No Intervention
    Arm Description
    Children with CP that will not be advised on a specific menu
    Arm Title
    ASD with recommended diet
    Arm Type
    Experimental
    Arm Description
    Children with ASD that will not be advised on a specific menu
    Arm Title
    ASD with a standard of care nutritional menu
    Arm Type
    No Intervention
    Arm Description
    Children with ASD that will not be advised on a specific menu
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrilect
    Intervention Description
    This intervention involves a comprehensive approach that includes a thorough nutritional assessment and individualized nutrition plan for children with cerebral palsy (CP) and Autism Spectrum Disorder (ASD), addressing their unique dietary needs and challenges. It encompasses nutritional counseling, dietary modifications when necessary, and seamless integration with other therapies, including speech therapy and psychological consultation. The overarching goal is to optimize growth, muscle function, and overall well-being in these children by providing tailored nutritional support alongside a holistic care approach.
    Primary Outcome Measure Information:
    Title
    bedridden days monthsmean duration of bedridden days over six months
    Description
    mean duration of bedridden days
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Weight-for-Age Z-Score
    Description
    The Weight-for-Age Z-Score serves as a secondary outcome measure in the study, primarily focusing on assessing changes in the study participants' weight status. Data collection involves anthropometric assessments and the utilization of reference growth charts, specifically the World Health Organization (WHO) reference charts, to record participants' weight relative to their age. This measurement employs the Z-score as the unit of measure, quantifying deviations in weight from the baseline. A positive Z-score indicates above-average weight for a given age group, while a negative Z-score indicates below-average weight, providing a valuable indicator of participants' nutritional status and growth trends over time.
    Time Frame
    six months
    Title
    Height-for-Age Z-Score
    Description
    The Height-for-Age Z-Score is a secondary outcome measure focused on evaluating changes in the study participants' height status. It involves anthropometric assessments and the use of WHO reference growth charts to record participants' height in relation to their age. The Z-score is the unit of measure, allowing for the quantification of height changes relative to the baseline. A positive Z-score indicates above-average height for the age group, while a negative Z-score indicates below-average height, offering a valuable indicator of participants' growth patterns and nutritional well-being over time.
    Time Frame
    six months
    Title
    BMI-for-Age Z-Score
    Description
    The secondary outcome measure, BMI-for-age Z-Score, assesses changes in the study participants' Body Mass Index (BMI) in relation to their age. This measurement relies on deriving BMI from weight and height measurements, with comparisons made using reference growth charts provided by the World Health Organization (WHO). The Z-score is employed as the unit of measure, enabling the quantification of BMI changes relative to the baseline. A positive Z-score signifies an above-average BMI for the age group, whereas a negative Z-score indicates a below-average BMI, serving as an essential metric for tracking variations in participants' nutritional status and body composition throughout the study.
    Time Frame
    six months
    Title
    Number of social interactions per week with non-family members
    Description
    The 'Number of Social Interactions per Week with Non-Family Members' is a quantitative measure that assesses the child's weekly engagement in social interactions with individuals outside their immediate family circle. It involves tracking and recording the frequency of diverse social exchanges, such as conversations, playdates, school-related interactions, and community engagements over a one-week period. This measure is instrumental in evaluating the child's social participation, integration into broader social networks, and overall quality of life. A higher number of interactions typically indicates greater social engagement and integration, while a lower number may signal reduced social participation, highlighting areas that require attention for the child's holistic development.
    Time Frame
    six months
    Title
    Total Number of New Spoken Words per Month
    Description
    Total Number of New Spoken Words per Month is a quantitative measure employed to evaluate a child's language development and communication skills over a one-month period. This measure involves systematically counting and recording the distinct words that the child effectively uses and articulates in conversations, interactions, or observations during the course of each month. Specifically, it focuses on identifying and tallying newly acquired words within the given timeframe.A higher number of newly spoken words typically indicates positive language development, reflecting effective vocabulary expansion and improved communication skills. A threshold of one new word per month is established as a meaningful indicator of progress.
    Time Frame
    six months
    Title
    Total Days of School or Kindergarten Attendance per month
    Description
    Total Days of School or Kindergarten Attendance per Month is a quantitative measure used to precisely assess a child's consistent participation in a formal educational setting, such as school or kindergarten, within the span of one month.A higher total number of days attended per month reflects more consistent participation in educational settings, indicating a stronger connection to learning opportunities and educational routines. Conversely, a lower total may indicate irregular attendance or potential challenges that require attention.
    Time Frame
    six month
    Title
    Number of Leisure Activities per Month
    Description
    The 'Number of Leisure Activities per Month' is a quantitative measure used to assess children's level of engagement in leisure and recreational pursuits over a one-month period. This measure involves systematically counting and documenting the quantity of diverse leisure activities, hobbies, or pastimes that the individual participates in during the designated month. Leisure activities encompass a wide range of choices, such as hobbies, sports, cultural events, or entertainment, selected for relaxation, enjoyment, and personal enrichment. A higher count of leisure activities often indicates a more diversified and active leisure lifestyle, potentially contributing to an enhanced overall quality of life, while a lower count may suggest limited engagement in leisure pursuits, highlighting opportunities for greater leisure satisfaction.
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A formal diagnosis made by a qualified neurologist. The diagnosis can span across the different types of CP and ASD. Expressed willingness to participate in the study. Availability for the entire duration of the study. Exclusion Criteria: Children with acute medical conditions or comorbidities that may significantly disrupt study assessments. Any severe infections within the last 10 days prior to the study. Presence of genetic syndromes that could influence nutritional status, e.g., Silver Russel syndrome or Down syndrome. Parents with cognitive impairments, which might pose challenges in their participation during assessments/intervention. Children who have been part of any major dietary or nutritional interventions in the last three months.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Randomized One-Center Controlled Trial on a Comprehensive Nutritional Intervention for Children With Cerebral Palsy and ASD

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