Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT) (INTENT)

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 Overview

• Status: Recruiting
• Conditions: Infant Nutrition; Diet Diversity
• Intervention / Treatment: Other: SpoonfulONE

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Beard; Phone Number: 919-660-5689; Email: claire.beard@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Recruiting
      • Duke Clinical Research Institute
      • Contact: Claire Beard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard diet with daily SpoonfulONE; 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.	Other: SpoonfulONE; 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.
No Intervention: Standard diet; Participants will feed on a standard diet only, with no intervention, and complete questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Before Brands, Inc
• Collaborators: Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SF-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No