Autism Spectrum DisorderNCT07884097
Individualized Parent-Based Nutrition Education in Preschool Children With Autism Spectrum Disorder
A study testing Individualized Parent-Based Nutrition Education Programme in people with Autism Spectrum Disorder, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Feeding difficulties, such as food selectivity and refusal to try new foods, are common among preschool children with autism spectrum disorder (ASD). These difficulties may affect children's dietary intake, eating habits, and daily activities. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Individualized Parent-Based Nutrition Education Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-6 years.
- For the ASD intervention and control groups: a diagnosis of autism spectrum disorder (ASD), with mild to moderate symptom severity assessed using the Childhood Autism Rating Scale (CARS).
- For the typically developing comparison group: children without an ASD diagnosis who exhibited typical development.
- Written informed consent provided by a parent or legal guardian.
Who cannot join
- Children outside the specified age range.
- For the ASD groups: severe ASD symptom severity according to the CARS assessment.
- Children whose parents or legal guardians did not provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Autism Research and Application Center
Ankara, Ankara, 06290
About this study
Official title: Effects of Individualized Parent-Based Nutrition Education on Feeding, Lifestyle, and Health Outcomes in Preschool Children With Autism Spectrum Disorder: A Randomized Controlled Trial
Feeding difficulties, such as food selectivity and refusal to try new foods, are common among preschool children with autism spectrum disorder (ASD). These difficulties may affect children's dietary intake, eating habits, and daily activities.
The aim of this study was to evaluate whether an individualized nutrition education programme delivered to parents could improve feeding behaviours, dietary intake, sleep habits, physical activity, and quality of life in preschool children with ASD.
Read more
The study included 45 children aged 3-6 years, including 30 children with ASD and 15 typically developing children. Children with ASD were randomly assigned to either a nutrition education group or a control group. Parents in the education group received eight individual nutrition education sessions over 16 weeks, supported by weekly telephone counselling. The typically developing children participated as a separate comparison group and were not randomly assigned.
The researchers assessed children's dietary intake, feeding behaviours, sleep habits, growth, physical activity, and screen time before and after the 16-week study period. Parent-reported quality of life was also evaluated.
Read the detailed description
Feeding and eating difficulties are frequently observed in children with autism spectrum disorder (ASD), particularly during the preschool years. These difficulties may include food selectivity, refusal of unfamiliar foods, limited dietary variety, and challenging mealtime behaviours. Such problems may affect dietary adequacy, growth, family mealtime routines, and overall well-being. Parent involvement is considered an important component of nutritional interventions because parents play a central role in children's food choices, eating environments, and daily feeding practices.
This study was designed to evaluate the effects of an individualized, parent-based nutrition education programme on dietary intake, feeding behaviours, sleep habits, physical activity, screen time, anthropometric indicators, and quality of life among preschool children with ASD.
The study used a randomized controlled design with an additional non-randomized comparison group of typically developing children. Children with mild to moderate ASD were randomly assigned to either an intervention group or an ASD control group. A separate group of typically developing children was included for comparison.
The intervention consisted of a 16-week individualized nutrition education programme delivered to parents of children with ASD. Parents received eight individual education sessions and weekly telephone counselling. The programme focused on supporting healthy eating habits, addressing feeding difficulties, improving dietary variety, and helping parents establish appropriate feeding practices and mealtime routines.
Assessments were conducted at baseline and at the end of the 16-week study period. Dietary intake was evaluated using three-day food records, while standardized questionnaires were used to assess feeding behaviours, sleep habits, and quality of life. Anthropometric measurements, physical activity, screen time, and gastrointestinal symptoms were also evaluated.
The study aimed to provide evidence on the potential role of individualized, parent-based nutrition education in supporting nutritional and behavioural outcomes in preschool children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Individualized Parent-Based Nutrition Education Programme
- Keywords
- Autism Spectrum Disorder Nutrition Education Parent-Based Intervention Feeding Behavior Dietary Intake Preschool Children Sleep Habits Quality of Life
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Parent-Based Nutrition Education ProgrammeBehavioural
The intervention consisted of a 16-week individualized, parent-based nutrition education programme for preschool children with autism spectrum disorder (ASD). Parents received eight individual nutrition education sessions and weekly telephone counselling throughout the intervention period. The programme aimed to improve children's dietary intake and feeding behaviours by providing parents with practical guidance on healthy eating, dietary variety, food selectivity, and appropriate feeding practices. Educational content was tailored to each child's nutritional needs and feeding difficulties. Parents were encouraged to apply the recommended strategies in their children's daily eating routines.
| Study group | Role | What they receive |
|---|---|---|
| ASD Intervention Group | Experimental | Not described Receives: Behavioral: Individualized Parent-Based Nutrition Education Programme |
| ASD Control Group | No intervention | Not described |
| Typically Developing Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Feeding Behaviors Assessed by the Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Feeding behaviors were assessed using the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), a parent-reported questionnaire evaluating child feeding behaviors and parental responses to feeding difficulties. Changes in scores from baseline to Week 16 were evaluated. Higher scores indicate more problematic feeding behaviors.
Kopyala
Measured: Baseline and Week 16
Secondary outcomes (2)
Change in Dietary Intake
Dietary intake was assessed using three-day food records. Daily energy, macronutrient, fiber, vitamin, and mineral intakes were estimated from dietary records and compared between baseline and Week 16. Nutrient intakes were expressed in nutrient-specific units.
Measured: Baseline and Week 16
Change in Parental Quality of Life Assessed by the Quality of Life in Autism Questionnaire (QOLA-P)
Parental quality of life was assessed using the Quality of Life in Autism Questionnaire - Parent Version (QOLA-P). The questionnaire evaluates parents' overall quality of life and the perceived impact of their child's autism-related difficulties. Changes in scores from baseline to Week 16 were evaluated, with higher scores indicating better parental quality of life.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Dec 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Önal, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884097
- Sponsor's protocol ID
- AU-ASD-NUTR-2020-16-239
- Status last verified
- Sep 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Parent-Based Nutrition Education on Feeding, Lifestyle, and Health Outcomes in Preschool Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07884097
- Acronym / sponsor ID
- AU-ASD-NUTR-2020-16-239
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder Nutrition Education Parent-Based Intervention Feeding Behavior Dietary Intake Preschool Children Sleep Habits Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Feeding difficulties, such as food selectivity and refusal to try new foods, are common among preschool children with autism spectrum disorder (ASD). These difficulties may affect children's dietary intake, eating habits, and daily activities.
The aim of this study was to evaluate whether an individualized nutrition education programme delivered to parents could improve feeding behaviours, dietary intake, sleep habits, physical activity, and quality of life in preschool children with ASD.
The study included 45 children aged 3-6 years, including 30 children with ASD and 15 typically developing children. Children with ASD were randomly assigned to either a nutrition education group or a control group. Parents in the education group received eight individual nutrition education sessions over 16 weeks, supported by weekly telephone counselling. The typically developing children participated as a separate comparison group and were not randomly assigned.
The researchers assessed children's dietary intake, feeding behaviours, sleep habits, growth, physical activity, and screen time before and after the 16-week study period. Parent-reported quality of life was also evaluated.
Detailed description
Feeding and eating difficulties are frequently observed in children with autism spectrum disorder (ASD), particularly during the preschool years. These difficulties may include food selectivity, refusal of unfamiliar foods, limited dietary variety, and challenging mealtime behaviours. Such problems may affect dietary adequacy, growth, family mealtime routines, and overall well-being. Parent involvement is considered an important component of nutritional interventions because parents play a central role in children's food choices, eating environments, and daily feeding practices.
This study was designed to evaluate the effects of an individualized, parent-based nutrition education programme on dietary intake, feeding behaviours, sleep habits, physical activity, screen time, anthropometric indicators, and quality of life among preschool children with ASD.
The study used a randomized controlled design with an additional non-randomized comparison group of typically developing children. Children with mild to moderate ASD were randomly assigned to either an intervention group or an ASD control group. A separate group of typically developing children was included for comparison.
The intervention consisted of a 16-week individualized nutrition education programme delivered to parents of children with ASD. Parents received eight individual education sessions and weekly telephone counselling. The programme focused on supporting healthy eating habits, addressing feeding difficulties, improving dietary variety, and helping parents establish appropriate feeding practices and mealtime routines.
Assessments were conducted at baseline and at the end of the 16-week study period. Dietary intake was evaluated using three-day food records, while standardized questionnaires were used to assess feeding behaviours, sleep habits, and quality of life. Anthropometric measurements, physical activity, screen time, and gastrointestinal symptoms were also evaluated.
The study aimed to provide evidence on the potential role of individualized, parent-based nutrition education in supporting nutritional and behavioural outcomes in preschool children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD Intervention Group | Experimental | Behavioral: Individualized Parent-Based Nutrition Education Programme |
| ASD Control Group | No intervention | – |
| Typically Developing Control Group | No intervention | – |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3-6 years.
- For the ASD intervention and control groups: a diagnosis of autism spectrum disorder (ASD), with mild to moderate symptom severity assessed using the Childhood Autism Rating Scale (CARS).
- For the typically developing comparison group: children without an ASD diagnosis who exhibited typical development.
- Written informed consent provided by a parent or legal guardian.
Key exclusion criteria (3 listed)
- Children outside the specified age range.
- For the ASD groups: severe ASD symptom severity according to the CARS assessment.
- Children whose parents or legal guardians did not provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Parent-Based Nutrition Education ProgrammeThe intervention consisted of a 16-week individualized, parent-based nutrition education programme for preschool children with autism spectrum disorder (ASD). Parents received eight individual nutrition education sessions and weekly telephone counselling throughout the intervention period. The programme aimed to improve children's dietary intake and feeding behaviours by providing parents with practical guidance on healthy eating, dietary variety, food selectivity, and appropriate feeding practices. Educational content was tailored to each child's nutritional needs and feeding difficulties. Parents were encouraged to apply the recommended strategies in their children's daily eating routines. | Behavioural | ASD Intervention Group |
Primary outcome
Change in Feeding Behaviors Assessed by the Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Time frame: Baseline and Week 16
Feeding behaviors were assessed using the Behavioral Pediatrics Feeding Assessment Scale (BPFAS), a parent-reported questionnaire evaluating child feeding behaviors and parental responses to feeding difficulties. Changes in scores from baseline to Week 16 were evaluated. Higher scores indicate more problematic feeding behaviors. Kopyala
2 secondary outcomes
Change in Dietary Intake
Time frame: Baseline and Week 16
Change in Parental Quality of Life Assessed by the Quality of Life in Autism Questionnaire (QOLA-P)
Time frame: Baseline and Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Parent-Based Nutrition Education Programme in people with Autism Spectrum Disorder, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Feeding Behaviors Assessed by the Behavioral Pediatrics Feeding Assessment Scale (BPFAS) (time frame: Baseline and Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.