Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Before Brands, Inc1 site in 1 country1,500 target enrollmentApril 9, 2021

ConditionsDiet Diversity Infant Nutrition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diet Diversity
Sponsor: Before Brands, Inc
Enrollment: 1500
Locations: 1
Primary Endpoint: Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 9, 2021

End Date

July 1, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Before Brands, Inc

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)

Time Frame: 12 months

Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)

Secondary Outcomes

Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups(12 months and 18 months)
Convenience, score through a questionnaire(12 months)
Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score(Baseline)
Proportion of participants compliant to daily feeding protocols, measured through a questionnaire(12 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(12 months and 18 months)
Mean age of participants when first introduced to various food groups, measured through a questionnaire(12 months)
Diet diversity, score(12 months)