Early Introduction and Sustained Ingestion (EISI) Using Two Educational Opportunities - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Compare the allergenic food intake frequency.
研究概览
简要总结
The objective of the study is to see whether early feeding of potentially allergic foods can be increased with educational materials alone or with educational materials and additional in-person support opportunities. This study will help guide what types of support pediatricians and allergists give to new parents.
详细描述
This 6 month feasibility pilot study will randomly assign caretaker/child dyads into two groups stratified by age; 50% will be assigned to the intervention group, the other 50% to the standard-of-care group (SOC). Using the foods of each families home and culture, participants in the standard-of-care group will be instructed through 3 educational packets in early introduction and infant nutrition metered one month apart. The content includes scientifically supported written, audio and video materials that are widely available to the general public. The SOC group has the option to come to the clinical research unit and introduce known allergenic foods under clinician supervision. The intervention group will receive the same 3 educational materials at the same time points as the SOC group. Both groups will complete the same quiz following each educational set of materials to evaluate the helpfulness and understanding of each educational module. The intervention group will additionally have in-person or live-stream opportunities instructing further about the same materials and provide the opportunity for participants to ask questions of the research team. The intervention group will be required to return to the research unit for at least one feeding introduction of a known allergenic food during the first 3 months of the study with clinicians present to supervise the feeding. The SOC group has the option to return to the clinic for at least one feeding introduction of a known allergenic food with clinical supervision. If a SOC participant had not consumed any known allergenic foods by the end of 3 months study enrollment, they will be required to come to the research clinic for a feeding introduction of a known allergenic food of their choice. Both groups will record the intake of known allergenic foods for the first 3 months. The second half of the study, intake of allergenic foods, diet diversity, fiber and fermented foods will be assessed by a validated food frequency questionnaire. Both infant groups will undergo a blood draw, skin tape strips, transepidermal water loss measurements and stool collections on the first and last visits. Mothers who are lactating will provide a nipple swab and have the option to collect a breast milk sample. Both groups will complete a pre and post study anxiety surveys and early introduction knowledge questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for both Infant and Caregiver/Parent Participants
- •Born term (37 weeks - 41 weeks gestation)
- •Infants with or without a family history of allergic disease
- •Infants with or without mild to moderate eczema
- •Infants who have not yet started consuming known allergenic foods (excluding cow's milk or soy if it is in their infant formula)
- •Parent or caregiver ≥ 18 years of age
- •Agree to infant blood draw (two)
- •Agree to participate in the 6 month research study
排除标准
- •Infants with a physician confirmed food allergy
- •Infants who do not eat fully by an oral route such as tube-fed or tube-supplemented babies
- •Infants with developmental delay
- •Infants with severe eczema
- •Infants who are already consuming known allergenic foods
- •Infants participating in another study looking at diet, oral immunotherapy or the use of a biological agent
研究组 & 干预措施
Standard of Care
The participants in the standard-of-care (SOC) group will be provided with three sets of nonsynchronous educational materials or modules to learn about early introduction of known food allergens and infant nutrition. A quiz will follow each educational module. Participants have the option to come to the research clinic to introduce known allergenic foods under clinician supervision. If none of the 9 most common known allergenic foods in the US (peanut, tree nut, hen's egg, cow's milk, soy, sesame, finned fish, shell fish, wheat) have been fed to the infant by the end of 3 months study enrollment the participant will be required to return to the research clinic for an introductory feeding of a known allergenic food of their choice under clinical supervision. The oral feeding will last approximately 1 hour.
Enhanced Educational Opportunities
The participants in the experimental group will be provided with the same three sets of educational materials or modules as the SOC group to learn about early introduction of food allergens and infant nutrition. Experimental participants will also attend 3 in-person or live video conferencing education sessions paired with each of the 3 educational modules. The educational classes last 30 minutes and are meant to enhance the information and allow opportunities for questions. The same quiz as the SOC group will follow each educational module. This arm will be required to return to the research clinic for at least one introductory feeding of a known allergenic food (peanut, tree nut, egg, milk, soy, sesame, finned fish, shell fish, wheat) during the first three months of the study under clinician supervision. The oral feeding will last approximately 1 hour.
干预措施: Education and Opportunities on Early Introduction (Behavioral)
Enhanced Educational Opportunities
The participants in the experimental group will be provided with the same three sets of educational materials or modules as the SOC group to learn about early introduction of food allergens and infant nutrition. Experimental participants will also attend 3 in-person or live video conferencing education sessions paired with each of the 3 educational modules. The educational classes last 30 minutes and are meant to enhance the information and allow opportunities for questions. The same quiz as the SOC group will follow each educational module. This arm will be required to return to the research clinic for at least one introductory feeding of a known allergenic food (peanut, tree nut, egg, milk, soy, sesame, finned fish, shell fish, wheat) during the first three months of the study under clinician supervision. The oral feeding will last approximately 1 hour.
干预措施: Clinician Supervised Feeding of Known Allergenic Food (Behavioral)
结局指标
主要结局
Compare the allergenic food intake frequency.
时间窗: At the start of intervention and month 1, month 2, month 3, month 4, and month 6.
Characterize diet diversity between the standard of care arm and the experimental arm.
Compare the infant age at which allergenic foods were introduced
时间窗: Baseline up to six months.
Compare the number of known allergenic foods introduced and sustained in the diet for 3 months in each study arm.
Compare the allergenic food intake frequency.
时间窗: At the start of intervention and month 1, month 2, month 3, month 4, month 5 and month 6.
The participants will self report how many times they took a particular allergenic food each month. This outcome will be compared between the two groups.
Compare the quantity of allergenic foods consumed.
时间窗: At the start of intervention and month 4, month 5 and month 6.
The participants will measure the amount of allergenic foods consumed daily as either: a taste, ≤ 1 teaspoon, 1 - 2 teaspoons or ≥ 3 tablespoons. The total amount of food consumed in a month will be compared between the two groups.
次要结局
未报告次要终点
研究者
R. Sharon Chinthrajah
Professor of Medicine, Pulmonary Allergy and Critical Care Medicine
Stanford University