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

May 26, 2025 updated by: Aliya Haider, Dow University of Health Sciences

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan
        • Effort Welfare Trust
      • Karachi, Sindh, Pakistan
        • Markaz e Umeed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Caregivers of Children (5-18 years) with Autism enrolled in Autistic or specialized Schools.
  2. Caregivers able to communicate in English or Urdu or Sindhi.
  3. Caregiver of one child with Autism.
  4. Caregivers with smartphone/laptop/IPhone and internet facility.

Exclusion Criteria:

  1. Caregiver of child with Autism living with any known food allergies.
  2. Caregiver of child with Autism enrolled in any other trial.
  3. Caregiver of child with Autism and any other mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caregivers of children with Autism Spectrum Disorder (ASD)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of nutrition education on nutrition literacy
Time Frame: Including pre test, intervention and post test - will require 6 months (roughly).
Nutrition literacy Assessment Instrument (NLit) will be used to assess the nutrition literacy.
Including pre test, intervention and post test - will require 6 months (roughly).
Effect of nutrition education on diet diversity
Time Frame: Including pre test, intervention and post test - will require 6 months (roughly).
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.
Including pre test, intervention and post test - will require 6 months (roughly).
Effect of oral hygiene education on oral hygiene practices.
Time Frame: Including pre test, intervention and post test - will require 6 months (roughly).
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.
Including pre test, intervention and post test - will require 6 months (roughly).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of experience of caregivers of children with Autism
Time Frame: Including pre test, intervention and post test - will require 6 months (roughly).
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.
Including pre test, intervention and post test - will require 6 months (roughly).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Actual)

August 3, 2024

Study Completion (Actual)

September 21, 2024

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

May 6, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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