Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

Not Applicable

• Conditions: Infant Nutrition; Diet Diversity
• Interventions: Other: SpoonfulONE

• Registration Number: NCT04803981
• Lead Sponsor: Before Brands, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Status Verified: 2021-04
• Study Start: 2021-04-09
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13
• Primary Completion: 2023-01-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard diet with daily SpoonfulONE	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 participants compliant to daily feeding protocols, measured through a questionnaire	12 months	Proportion of participants compliant to daily feeding protocols, measured through a questionnaire
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
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
Diet diversity, score	12 months	Diet diversity score measured through regular questionnaires where participants will indicate which foods they are eating

Trial Locations

Locations (1)

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States