Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Before Brands, Inc1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,500

Conditions

Diet Diversity Infant Nutrition

Interventions

SpoonfulONEOTHER

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.

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke Clinical Research Institute

Durham, North Carolina, United States

RECRUITING

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

Secondary Outcomes

Parent/guardian comfort level of introducing food proteins into the participant's diet, Likert score

Time frame: Baseline

Diet diversity, score

Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating

Time frame: 12 months

Mean age of participants when first introduced to various food groups, measured through a questionnaire

Time frame: 12 months

Convenience, score through a questionnaire

Convenience of using daily SpoonfulONE, measured through a questionnaire

Time frame: 12 months

Proportion of participants compliant to daily feeding protocols, measured through a questionnaire

Time frame: 12 months

Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 9 common food groups

Central Contacts

Claire Beard

CONTACT

919-660-5689 claire.beard@duke.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.