Feasibility of next-generation weaning nuts recipes by multidisciplinary (Toward the revision of the guide for breastfeeding and weaning)

UMIN ID: UMIN000055657

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Infants who will be 5 months to 1.5 years old at the start of this study
• Date of first enrollment: 2024/10/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Nutritionists and medical staff developed baby food recipes for walnuts, cashews, peanuts, hazelnuts, and almonds. We will recruit study candidates through our website, social networking sites, posters, and pamphlets through our online form. Candidates come to the National Center for Child Health and Development, and we obtain informed consent for the study participants' caregivers and register them. After the study registration, we provide recipes to the caregivers. We evaluated the recipes using an electronic questionnaire to the participants' caregivers after the registration and two months later.

Outcome(s)

• Primary Outcome: Feasibility. Evaluate simplicity, reproducibility, continuation, and satisfaction at the time of first intake and after 2 months, based on parents' reports through questionnaires: The total score obtained for the 5-point evaluation question is considered feasible if the total score is at least 3 points for the evaluation item x 3 points or more.
• Secondary Outcome: Adverse events related to the recipe food (allergic symptoms, aspiration, etc.; evaluated by a health care provider during face-to-face contact and contacted when adverse events occur during home consumption) Intake of nuts 2 months after recipe was provided (evaluated by questionnaire after 2 months)

Key inclusion & exclusion criteria

• Age minimum: 5months-old
• Age maximum: 18months-old
• Gender: Male and Female
• Exclude criteria: 1. Infants with complications or history of atopic dermatitis 2. Infants with food allergy history 3. Infants who have not ingested wheat yet 4. Infants who are unable to take baby food in a form suitable for their age group due to swallowing problems 5. Infants whose caregivers cannot communicate adequately in Japanese 6. Infants who suffer from a disease that would interfere with the study 7. Caregivers who are unable to comply with the prohibition of disclosure of the contents of this study and the recipes 8. Physicians determines to be unsuitable for the study

Related Information

• Primary Sponsor: National Center for Child Health and Development
• Source(s) of Monetary Support: Japan Science and Technology Agency