Nutritional assessment and dietary intervention for children (3- 10 years) with Autism Spectrum Disorder
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Madhumita Rajendraprasad
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- 1. Change in ATEC score (total and domain-wise) before and after 3 months of dietary intervention.
概览
简要总结
This prospective interventional study aims to evaluate the impact of tailored dietary interventions on autism symptomatology and nutritional status in children aged 3 to 10 years diagnosed with Autism Spectrum Disorder. A total of 110 children will be enrolled. At baseline, participants will undergo comprehensive assessments, including anthropometric measurements, dietary intake analysis, biochemical parameters, and a clinical evaluation, to determine their nutritional status. Autism related behaviors will be assessed using standardized tools, such as the Autism Treatment Evaluation Checklist (ATEC) and the Brief Autism Mealtime Behavior Inventory (BAMBI). Food intolerances will be identified using an elimination diet approach, and individualized nutrition plans will be developed based on these findings. The intervention will be implemented over a period of 3 months after which post-intervention assessments will be conducted. The primary outcome is the change in ATEC scores before and after the dietary intervention reflecting the effect of nutrition on autism symptomatology. Secondary outcomes include changes in BAMBI scores, improvements in nutritional status, dietary adequacy, the incidence of Avoidant Restrictive Food Intake Disorder ARFID, and correlations between food intolerances and autism severity. Findings from the study aim to establish evidence based dietary strategies for children with ASD and promote knowledge transfer to caregivers and the broader community enabling sustainable nutrition management and improved quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)(—)
- 性别
- All
入选标准
- •Children diagnosed with ASD based on ISAA between the age group of 3-10 years Either gender Recruited with written informed consent.
排除标准
- •Diagnosis of Asperger syndrome, Rett syndrome or any other congenital disease Chronic seizures or an acute or chronic affective disease during the past three months.
结局指标
主要结局
1. Change in ATEC score (total and domain-wise) before and after 3 months of dietary intervention.
时间窗: 1. Time Points: Baseline and 3 months post-intervention
次要结局
- 1. Change in BAMBI scores indicating mealtime behavior improvement.(2. Incidence and pattern of food intolerances and ARFID among enrolled children.)
研究者
Madhumita Rajendraprasad
National Institute of Physical Medicine and Rehabilitation