An observational study in Autism Spectrum Disorder, sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Chinese University of Hong Kong · Observational
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).
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:
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.
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.
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.
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.
Mealtime behaviours
Mealtime behaviours measured using the Chinese version of the Brief Autism Mealtime Behaviour Inventory
Time frame: baseline
Gastrointestinal symptoms
Gastrointestinal symptoms measured using the Chinese version of the Questionnaire on Pediatric Gastrointestinal Symptoms - Rome III (QPGS-RIII)
Time frame: baseline
Gut microbiota profile
Gut microbiota profile measured using 16s sequencing
Time frame: baseline
Current diet quality
Current diet quality measured using 3-day diet record
Time frame: baseline
Usual diet quality
Usual diet quality measured using food frequency questionnaire
Time frame: baseline
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong