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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diet with daily SpoonfulONE | Experimental | 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. |
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| Standard diet | No Intervention | Participants will feed on a standard diet only, with no intervention, and complete questionnaires |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpoonfulONE | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Beard | Contact | 919-660-5689 | claire.beard@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Institute | Recruiting | Durham | North Carolina | 27701 | United States |
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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 |