Eating Behaviours, Diet and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders

July 28, 2019 updated by: Ruth Chan, Chinese University of Hong Kong

Eating Behaviours, Diet Quality and Gastrointestinal Symptoms in Children With Autism Spectrum Disorders and Typically Developing Children: a Case-control Study

This case-control study aims to compare the differences in eating behaviours, nutritional status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years with autism spectrum disorders (ASD) (n=65) and typically developing children (TDC) (n=65).

Study Overview

Status

Completed

Detailed Description

Objective: To compare the differences in eating behaviours, nutritional status, diet quality and gastrointestinal (GI) health between Chinese children aged 3-6 years with autism spectrum disorders (ASD) and typically developing children (TDC).

Hypotheses:

  1. Children with ASD will show more problematic mealtime behaviours as represented by higher scores of 'limited variety' and 'food refusal' domains of the BAMBI compared to typically developing children
  2. Children with ASD will have more GI symptoms, in particular constipation and diarrhea compared to typically developing children
  3. Children with ASD will have a lower ratio of Bacteroidetes to Firmicutes than the typical control children
  4. Children with ASD will have less desirable diet quality in terms of lower dietary index, lower dietary diversity score and lower intake of fibre, iron, calcium, zinc and vitamin C compared to typically developing children
  5. A better diet quality will be associated with a more favourable gut microbial composition in children with and without ASD

Design and subjects: Case-control study including 65 families with children of ASD and 65 families with TDC matched by child's age and sex.

Outcomes: The primary outcomes will be the difference in mean scores of 'limited variety' and 'food refusal' domains of the Chinese version of BAMBI between children with ASD and typically developing children. The secondary outcomes will be the difference in the occurrence of GI symptoms in terms of constipation and diarrhea, as well as the difference in the gut microbiota profile in terms of the Bacteroidetes to Firmicutes ratio between children with ASD and typically developing children. The tertiary outcome will be the difference in the diet quality in terms of lower dietary index, lower dietary diversity score and lower intake of fibre, iron, calcium, zinc and vitamin C in children with ASD and typically developing children.

Study Type

Observational

Enrollment (Actual)

130

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

      • Hong Kong, China
        • Chinese University of Hong Kong

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

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sixty five families with children of ASD of Chinese origin aged between 3 and 6 years and 65 control families with typically developing children matched by child's age (within 6 months) and sex will be recruited through invitation letters using a convenience sampling method in nurseries and kindergartens, in particular those with integrated programmes for ASD children. Some other possible channels for recruiting families with ASD children will include non-governmental organizations (NGOs) and some ASD family supporting groups.

Description

Inclusion Criteria for Cases:

Families with their children diagnosed with ASD by paediatrician or clinical psychologist according to the standard of the fourth or fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-V) will be included.

Exclusion Criteria for Cases:

Families will be excluded if their children have the following conditions.

  • Diagnosed with chronic seizures
  • Suffered from recent infection 1-month prior to data and sample collection
  • With diseases or disorders that affect dietary/physical activity habits (e.g. diabetes, cystic fibrosis, cerebral palsy)
  • Usage of antibiotics and antifungal medications 1-month prior to data and sample collection
  • Currently participating or have recently participated (i.e. 1-month prior to data and sample collection) in any trials or dietary intervention programs
  • With other major medical or psychological illness, as judged by the investigators as ineligible to participate

Inclusion Criteria for Controls:

Families with typically developing children matched by child's age (i.e. within 6 months of age) and sex will be included. Children without ASD, delays in motor and language development, as well as behaviors as reported by their parents, and those do not have first-degree relatives with ASD will be included. Parents will also be asked to complete the Chinese validated version of Social Responsiveness Scale (SRS). For children who are screened with positive results, they will be further assessed by a developmental pediatrician to ascertain the autistic status. Only those who are screened negative, or those who are screened positive but subsequently ascertained by the developmental pediatrician being free from autistic symptoms will be included.

Exclusion Criteria for Controls:

The exclusion criteria will be same as those for the families with children of ASD.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mealtime behaviours
Time Frame: baseline
Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms
Time Frame: baseline
Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)
baseline
Gut microbiota profile
Time Frame: baseline
Gut microbiota profile measured using 16s sequencing
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Current diet quality
Time Frame: baseline
Current diet quality measured using 3-day diet record
baseline
Usual diet quality
Time Frame: baseline
Usual diet quality measured using food frequency questionnaire
baseline

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)

November 4, 2017

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 28, 2019

Last Verified

July 1, 2019

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

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.

Clinical Trials on Autism Spectrum Disorder

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