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

NCT05860829 | Completed DMC

• 1 other identifier: DowUniHS
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Keywords

Oral hygiene; Nutrition literacy; Diet Diversity; Caregiver's experience; Telehealth; Caregiver

Outcome Measures

Primary Outcomes (3)

• Effect of nutrition education on nutrition literacy

  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

  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.

  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 Outcomes (1)

• Assessment of experience of caregivers of children with Autism

  Including pre test, intervention and post test - will require 6 months (roughly).

Study Arms (1)

Caregivers of children with Autism Spectrum Disorder (ASD)

EXPERIMENTAL

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.

Behavioral: Educational

Interventions

Educational BEHAVIORAL

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.

Caregivers of children with Autism Spectrum Disorder (ASD)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (2)

Effort Welfare Trust

Karachi, Sindh, Pakistan

Location

Markaz e Umeed

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: May 23, 2023
• Primary Completion: August 3, 2024
• Study Completion: September 21, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

PA (2)