search
Back to results

Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Study

Primary Purpose

Autism Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Oral hygiene, Nutrition literacy, Diet Diversity, Caregiver's experience, Telehealth, Caregiver

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools. Caregivers able to communicate in English or Urdu or Sindhi. Caregiver of one child with Autism. Caregivers with smartphone/laptop/IPhone and internet facility. Exclusion Criteria: Caregiver of child with Autism living with any known food allergies. Caregiver of child with Autism enrolled in any other trial. Caregiver of child with Autism and any other mental disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Caregivers of children with Autism Spectrum Disorder (ASD)

    Arm Description

    Arm includes only the caregivers of children with ASD. The knowledge of caregivers of children with ASD regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children will be assessed. Then, educating caregivers on diet diversities, and effective oral health education, expecting from it to the eating habits and oral hygiene of children living with autism.

    Outcomes

    Primary Outcome Measures

    Effect of nutrition education on nutrition literacy
    Nutrition literacy Assessment Instrument (NLit) will be used to assess the nutrition literacy.
    Effect of nutrition education on diet diversity
    Diet Diversity Score (DDS) will be used to assess diet diversity. There are twelve questions in this questionnaire. The number of food groups consumed by the child from the total number of twelve food groups will either be '0' or '1' which will be summed up. The scoring will be done, low will be ≤ 4 food groups, medium will be considered as 5 to 8 food groups, and high will be 9 to 12 food groups.
    Effect of oral hygiene education on oral hygiene practices.
    Oral hygiene assessment score will be used to assess oral hygiene practices. There are a total of ten questions in this section. The interpretation will be done with the help of pre oral hygiene education and post oral hygiene education and the difference it creates among the caregivers of children with Autism.

    Secondary Outcome Measures

    Assessment of experience of caregivers of children with Autism
    Caregiver burden assessment scoring will be done by COPE Index. COPE index is a 15 item questionnaire developed to assess the caregiver experiences. Questions cover negative, positive and social aspects of caregiving. Score above 12 is for Negative Impact or below 12 for Positive Value.

    Full Information

    First Posted
    May 6, 2023
    Last Updated
    July 14, 2023
    Sponsor
    Dow University of Health Sciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05860829
    Brief Title
    Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Study
    Official Title
    Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Stud
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    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 goal of this interventional study is to assess the knowledge of caregivers of children with Autism Spectrum Disorder (ASD) regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children. The main aims to answer are: Educating caregivers on Diet diversities Improving oral health habits Participants will have to Fill questionnaires Undergo educational sessions Fill post education questionnaires Researchers will compare pre and post educational questionnaires to see if the intervention makes a difference.
    Detailed Description
    Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder defined by deficits in social communication and the presence of restricted and repetitive behaviors and interests. The disorder incorporates the constraints and typical behaviors in early childhood, which later becomes problematic to function in society. Although the reason of ASD are unexplained yet, however, air pollution, organic toxicants, seasonal factors, psychological stress, migration, birth order and nutrition may have a close relationship with the incidence of ASD. Emphasizing on the fact that it is a lifelong condition and there is no specific cure to it, it can only be managed and assisted by caregivers specially. Every individual with ASD have a unique and different behavioral pattern. These behavioral patterns are managed by experts of behavior management such as speech or occupational therapists. Poor oral hygiene is widely reported among children with autism, thus can elevate the likelihood of dental cavities and bad breath. Dental health can be further deteriorated if a child with ASD prefers soft, sweet and sticky food preferences as unhealthy diet intake and limited diet diversity. Food selectivity and other feeding problems are endemic in children with autism spectrum disorders (ASD). In Pakistan, few studies have comprehensively looked at the children with special needs. As Pakistan is a Low-Middle-Income country (LMIC) with limited sources and ASD is a domain that still needs more research work to be done. There is a majority of population that overlook the topic and then there is a category that strongly believes myths and misconceptions that evolve regarding 'treatment' and management of Autism in individuals. Another setback is a limited number Professionals with sound knowledge of the disorder that can cater to majority individuals and their caregivers, providing assistance in how to manage the most basic things like oral hygiene and nutritional education - that can ultimately encourage the reduction of burden in caregivers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    Oral hygiene, Nutrition literacy, Diet Diversity, Caregiver's experience, Telehealth, Caregiver

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A pre-test will be conducted to explore the level of knowledge of the caregivers regarding oral hygiene and nutrition literacy of children with ASD. In-depth interviews will be conducted in order to identify the problems faced by caretakers till the saturation is reached. A semi-structured interview guide and caregiver education program will be developed related to dietary intake and oral hygiene of the child with autism for the caregivers. A dentist will provide education on oral hygiene and a registered dietician on nutrition literacy and diet diversity via telehealth. A post-test will be conducted after completion of all the sessions to assess the impact of the intervention.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    123 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Caregivers of children with Autism Spectrum Disorder (ASD)
    Arm Type
    Experimental
    Arm Description
    Arm includes only the caregivers of children with ASD. The knowledge of caregivers of children with ASD regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children will be assessed. Then, educating caregivers on diet diversities, and effective oral health education, expecting from it to the eating habits and oral hygiene of children living with autism.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational
    Intervention Description
    Caregivers of children with ASD will be sampled that are enrolled in Autism specialized Schools or centers. Tools and group education sessions will be developed in Urdu, English and Sindhi language. A caregiver education program session will be conducted by a practicing dentist and a registered dietitian in Urdu1 and English. Considering the ease of caregivers, cost-effectiveness and managing flexible hours, tele-health will be practiced for education program. A post-test will be conducted to assess the impact of the educational program on the knowledge of caregivers.
    Primary Outcome Measure Information:
    Title
    Effect of nutrition education on nutrition literacy
    Description
    Nutrition literacy Assessment Instrument (NLit) will be used to assess the nutrition literacy.
    Time Frame
    Including pre test, intervention and post test - will require 6 months (roughly).
    Title
    Effect of nutrition education on diet diversity
    Description
    Diet Diversity Score (DDS) will be used to assess diet diversity. There are twelve questions in this questionnaire. The number of food groups consumed by the child from the total number of twelve food groups will either be '0' or '1' which will be summed up. The scoring will be done, low will be ≤ 4 food groups, medium will be considered as 5 to 8 food groups, and high will be 9 to 12 food groups.
    Time Frame
    Including pre test, intervention and post test - will require 6 months (roughly).
    Title
    Effect of oral hygiene education on oral hygiene practices.
    Description
    Oral hygiene assessment score will be used to assess oral hygiene practices. There are a total of ten questions in this section. The interpretation will be done with the help of pre oral hygiene education and post oral hygiene education and the difference it creates among the caregivers of children with Autism.
    Time Frame
    Including pre test, intervention and post test - will require 6 months (roughly).
    Secondary Outcome Measure Information:
    Title
    Assessment of experience of caregivers of children with Autism
    Description
    Caregiver burden assessment scoring will be done by COPE Index. COPE index is a 15 item questionnaire developed to assess the caregiver experiences. Questions cover negative, positive and social aspects of caregiving. Score above 12 is for Negative Impact or below 12 for Positive Value.
    Time Frame
    Including pre test, intervention and post test - will require 6 months (roughly).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools. Caregivers able to communicate in English or Urdu or Sindhi. Caregiver of one child with Autism. Caregivers with smartphone/laptop/IPhone and internet facility. Exclusion Criteria: Caregiver of child with Autism living with any known food allergies. Caregiver of child with Autism enrolled in any other trial. Caregiver of child with Autism and any other mental disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aliya Haider, MPH
    Phone
    +92 333 3666493
    Email
    drtoothaliyahaider@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sumaira Nasim, Ph.D.
    Phone
    +923352618247
    Email
    sumaira.nasim@duhs.edu.pk

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Study

    We'll reach out to this number within 24 hrs