Diet Diversity, Infant Nutrition
Conditions
Brief summary
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.
Interventions
OTHERSpoonfulONE
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.
Sponsors
Duke Clinical Research Institute
Before Brands, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 4-6 months of age at time of consent 2. Provision of signed and dated informed consent form parent/guardian(s) 3. Parent/guardian(s) stated willingness to introduce within 12 months and feed the participant 5 common foods, including peanuts, cashew, egg, sesame, and cod 4. In good general health as evidenced by medical history reported by the parent/guardian(s) 5. No known allergy to any of the ingredients in the study intervention (SO), their components, or excipients
Exclusion criteria
1. Known physician confirmed allergies to any of the ingredients in SO at the time of consent 2. Gastroesophageal reflux disease (GERD) diagnosed by a physician and requiring treatment (i.e., pharmacological and/or non-pharmacological treatments such as a wedge) 3. Participant or parent/guardian unsuitable for the study, at the discretion of the investigator 4. Sibling in the home is already enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame) | 12 months | Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet diversity, score | 12 months | Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating |
| Mean age of participants when first introduced to various food groups, measured through a questionnaire | 12 months | Mean age of participants when first introduced to various food groups, measured through a questionnaire |
| Convenience, score through a questionnaire | 12 months | Convenience of using daily SpoonfulONE, measured through a questionnaire |
| Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score | Baseline | Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score |
| Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups | 12 months and 18 months | Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups |
| 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 | 12 months and 18 months | 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 |
| Proportion of participants compliant to daily feeding protocols, measured through a questionnaire | 12 months | Proportion of participants compliant to daily feeding protocols, measured through a questionnaire |
Countries
United States
Contacts
Primary ContactClaire Beard
Outcome results
None listed