Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Study Overview
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Brief Summary
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This is a randomized, controlled, open-label, pragmatic, direct-to-participant trial designed for infants. The study will be conducted using a mobile application platform to engage parents with healthy infants and parents with infants with eczema in introducing complementary feeding in line with new feeding guidelines for diet diversity, gather parental experiences of feeding, support early introduction of different food proteins and support feeding of SpoonfulONE.

Official Title
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Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Conditions
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Diet Diversity, Infant Nutrition

Intervention / Treatment
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* Other: SpoonfulONE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 4-6 months of age at time of consent Provision of signed and dated informed consent form parent/guardian(s) Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod In good general health as evidenced by medical history reported by the parent/guardian(s) No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients Exclusion Criteria: Known physician confirmed allergies to any of the ingredients in SO at the time of consent Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge) Participant or parent/guardian unsuitable for the study, at the discretion of the investigator Sibling in the home is already enrolled in the study

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard diet with daily SpoonfulONE<br>Participants will receive one serving of SO (one of three possible forms of SO: mix-ins, puffs, or crackers) daily in addition to a standard diet. The SO form fed on a given day will be at the discretion of the parent/guardian. | Other: SpoonfulONE<br>* SpoonfulONE is a line of nutritional food products designed to help improve diet diversity starting in early infancy. SpoonfulONE covers a wide range of food proteins. Each product contains 30 mg of peanuts, milk, shellfish (shrimp), tree nuts (almond, cashew, hazelnut, pecan, pistachio, and walnut), egg, fish (cod and salmon), grains (wheat and oat), soy, and sesame.<br>|
| No Intervention: Standard diet<br>Participants will feed on a standard diet only, with no intervention, and complete questionnaires | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame) | Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score | Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score | Baseline | 
| Diet diversity, score | Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating | 12 months | 
| Mean age of participants when first introduced to various food groups, measured through a questionnaire | Mean age of participants when first introduced to various food groups, measured through a questionnaire | 12 months | 
| Convenience, score through a questionnaire | Convenience of using daily SpoonfulONE, measured through a questionnaire | 12 months | 
| Proportion of participants compliant to daily feeding protocols, measured through a questionnaire | Proportion of participants compliant to daily feeding protocols, measured through a questionnaire | 12 months | 
| Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups | Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups | 12 months and 18 months | 
| Proportion of participants on SpoonfulONE compared to the proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire | Proportion of participants on SpoonfulONE compared to proportion of participants on the non-intervention arm who tolerated each individual food groups of the 9 selected food groups, measured through a questionnaire | 12 months and 18 months |