The Effects of Nutritional Counseling on Maternal Quality of Life of Children With Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
研究概览
简要总结
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with FA, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult mother of a patient <12 years of age diagnosed with FA
排除标准
- •Mother's age <18 years
- •Mother unable to understand Italian
- •Mother suffering from chronic diseases
- •Mother suffering from epilepsy
- •Mother suffering from neoplasms
- •Mother suffering from immunodeficiencies
- •Mother suffering from chronic infections
- •Mother suffering from autoimmune diseases
- •Mother suffering from inflammatory bowel diseases
- •Mother suffering from functional gastrointestinal disorders
- •Mother suffering from celiac disease
- •Mother suffering from genetic-metabolic diseases
- •Mother suffering from tuberculosis
- •Mother suffering from congenital heart disease
- •Mother suffering from tuberculosis
- •Mother suffering from cystic fibrosis
- •Mother suffering from other chronic pulmonary diseases
- •Mother suffering from major malformations
- •Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract
- •Mother suffering from diabetes
- •Mother suffering from neuropsychiatric and neurological disorders
- •Mother suffering from eosinophilic disorders of the gastrointestinal tract
- •Mother not living with her child with FA
- •Concomitant presence in the child with FA of chronic diseases
- •Concomitant presence in the child with FA of epilepsy
- •Concomitant presence in the child with FA of neoplasms
- •Concomitant presence in the child with FA of immunodeficiencies
- •Concomitant presence in the child with FA of chronic infections
- •Concomitant presence in the child with FA of autoimmune diseases
- •Concomitant presence in the child with FA of inflammatory bowel diseases
- •Concomitant presence in the child with FA of functional gastrointestinal disorders
- •Concomitant presence in the child with FA of celiac disease
- •Concomitant presence in the child with FA of genetic-metabolic diseases
- •Concomitant presence in the child with FA of tuberculosis
- •Concomitant presence in the child with FA of congenital heart disease
- •Concomitant presence in the child with FA of tuberculosis
- •Concomitant presence in the child with FA of cystic fibrosis
- •Concomitant presence in the child with FA of other chronic lung diseases
- •Concomitant presence in the child with FA of major malformations
- •Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract
- •Concomitant presence in the child with FA of diabetes
- •Concomitant presence in the child with FA of neuropsychiatric and neurological disorders
- •Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract
- •Concomitant presence in the child with FA of allergic diseases other than FA.
研究组 & 干预措施
Mothers of children with food allergy diagnosed by a multidisciplinary team
Mothers of children with food allergy diagnosed by a multidisciplinary team (Group 1) already followed for at least 6 months by the Tertiary Center of Pediatric Allergology..
Mothers of children with food allergy diagnosed by a non-multidisciplinary team
Mothers of children with food allergy diagnosed by a non-multidisciplinary team who plan to visit for the first time the Tertiary Center of Pediatric Allergology.
干预措施: Personalized Nutritional Counseling by a multidisciplinary team (Behavioral)
结局指标
主要结局
FASE-P diagnosed by a multidisciplinary team (Group 1) or diagnosed by a non-multidisciplinary team (Group 2).
时间窗: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FASE-P questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
FAQL-PB
时间窗: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQL-PB questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
FAQLQ-PF
时间窗: baseline
To explore potential differences at baseline (T0) in the quality of life, provided by the FAQLQ-PF questionnaire, of mothers of children with food allergy diagnosed by a multidisciplinary team already followed for at least 6 months by the Tertiary Center of Pediatric Allergology (University Federico II) (Group 1) and of mothers of children with food allergy diagnosed for at least 6 months (by a non-multisciplinary team) who plan to visit for the first time the same Center (Group 2).
次要结局
- FASE-P at 6 months Group 2 versus Group 1(6 months)
- Z-score length for age Group 2 versus Group 1(At baseline and at 6 months)
- Z-score weight for age Group 2(At baseline and at 6 months)
- FASE-P Group 2(6 months)
- FAQL-PB Group 2(6 months)
- FAQLQ-PF Group 2(6 months)
- Z-score length for age Group 2(At baseline and at 6 months)
- Z-score weight for age Group 2 versus Group 1(At baseline and at 6 months)
- FAQLQ-PF Group 2 versus Group 1(6 months)
- Z-score BMI for age Group 2(At baseline and at 6 months)
- FAQL-PB Group 2 versus Group 1(6 months)
- Z-score BMI for age Group 2 versus Group 1(At baseline and at 6 months)
研究者
Roberto Berni Canani, MD, PhD
Associate professor- Chief of the Pediatric Allergy Program at the Department of Traslational Medical Science
Federico II University