Clinical trial NCT04803981: Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
Official title: Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet Diversity
Infant Nutrition
Lead sponsor: Before Brands, Inc
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2021-03-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
timeFrame: 12 months
Secondary outcomes:
measure: Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score
timeFrame: Baseline
measure: Diet diversity, score
timeFrame: 12 months
measure: Mean age of participants when first introduced to various food groups, measured through a questionnaire
timeFrame: 12 months
measure: Convenience, score through a questionnaire
timeFrame: 12 months
measure: Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
timeFrame: 12 months
measure: Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups
timeFrame: 12 months and 18 months
measure: 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
timeFrame: 12 months and 18 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
References: