A Clinical Trial of the "Exploradores de Sabores" Intervention to Improve Food Variety and Nutritional Status in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Food Variety
研究概览
简要总结
The goal of this randomized, single-blind clinical trial is to evaluate the effectiveness of the Exploradores de Sabores parent-mediated nutrition intervention in reducing food selectivity and improving dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms among children aged 4 to 11 years with Autism Spectrum Disorder (ASD). The intervention consists of a standardized 15-week parent training program that combines nutrition education, behavioral feeding strategies, sensory-based approaches, and structured food exposure activities implemented by caregivers at home.
The main questions it aims to answer are:
- Does the Exploradores de Sabores intervention improve food selectivity and dietary variety in children with Autism Spectrum Disorder compared with Education as Usual (EAU)?
- Does the intervention improve mealtime behaviors, nutritional status, and gastrointestinal symptoms compared with Education as Usual (EAU)?
Researchers will compare participants assigned to the Exploradores de Sabores intervention with those receiving Education as Usual (EAU) to determine whether the intervention results in greater improvements in food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms.
Participants will:
- Complete study assessments at baseline and immediately after completion of the 15-week intervention.
- Be randomly assigned to either the Exploradores de Sabores intervention or the Education as Usual (EAU) control group.
- If assigned to the intervention group, caregivers will participate in a standardized 15-week parent training program and implement structured home-based feeding activities using the intervention manual and educational materials.
- If assigned to the Education as Usual (EAU) control group, caregivers will receive 15-week parent training in general recomendations that include healthy meal planning, hydration, and general guidance for promoting balanced eating habits. Children will undergo assessments of food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms at each study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to participants' group assignment throughout data collection and outcome assessment. Due to the nature of the parent-mediated behavioral intervention, participants, caregivers, and intervention providers cannot be blinded.
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with Autism Spectrum Disorder (ASD) requiring support levels 1, 2, or 3, without cognitive impairment.
- •Primary caregivers with sufficient availability to participate in and implement the intervention.
- •Children with or without mild functional gastrointestinal symptoms.
- •Children experiencing difficulties with the introduction or acceptance of new foods.
- •Children with clinically significant food selectivity, as determined by AUT-EAT
- •Children with malnutrition.
排除标准
- •Current use of medications known to substantially affect appetite or feeding behavior (e.g., cyproheptadine, clonidine, or other appetite-modifying medications).
- •Syndromic Autism Spectrum Disorder (ASD).
- •Clinically significant gastrointestinal disorders requiring active medical treatment.
- •Medical conditions that significantly affect nutritional status, growth, or feeding behavior (e.g., phenylketonuria, cystic fibrosis, inflammatory bowel disease, endocrine disorders, or eating disorders).
- •Cases in which the parent or legal guardian attending the training sessions is not the individual responsible for implementing the intervention activities with the child at home.
结局指标
主要结局
Food Variety
时间窗: Baseline, mid-intervention, and immediately after completion of the 15-week intervention.
Dietary variety will be assessed using the Food Variety Questionnaire developed by the Food and Agriculture Organization (FAO). The questionnaire records foods consumed from predefined food groups over a specified reference period. A dietary variety score is calculated based on the number of different food groups consumed, Scores range from 0 to 16, corresponding to the number of food groups consumed. Higher scores indicate greater dietary variety and a better dietary outcome.The questionnaire will be completed by the child's primary caregiver.
Nutritional status
时间窗: From enrollment to the end of treatment at 15 weeks
Nutritional status will be assessed using the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP). STAMP evaluates nutritional risk based on the child's clinical diagnosis, recent nutritional intake, weight and height measurements, and anthropometric indicators. Scores range from 0 to 9. A score of 0-1 indicates low nutritional risk, 2-3 indicates medium risk, and ≥4 indicates high nutritional risk. Higher scores indicate a greater risk of malnutrition and therefore a worse outcome. Higher scores indicate a greater risk of malnutrition.
Food Neophobia
时间窗: Baseline and immediately after completion of the 15-week intervention.
Food neophobia will be assessed using the Food Neophobia Test Tool, a validated caregiver-reported questionnaire that measures children's reluctance to try unfamiliar foods. The instrument uses a 7 Likert-type scale ranging from "Strongly disagree" to "Strongly agree," The total score ranges from 10 to 70, obtained by summing the responses to the 10 items after reverse-scoring the appropriate items. Higher scores indicate greater food neophobia and therefore a worse outcome.
次要结局
- Food Selectivity(Baseline and immediately after completion of the 15-week intervention.)
- Gastrointestinal health(Baseline and immediately after completion of the 15-week intervention.)
- Caregiver Satisfaction with the Intervention(At the end of the intervention, week 15)
研究者
Connie Johanne Lopez Verdugo
Doctoral Candidate
Universidad Autonoma de Baja California