Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

NCT ID: NCT04803981

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2023-07-01

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.

Conditions

Diet Diversity; Infant Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SpoonfulONE

Intervention Type: OTHER

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.

Standard diet

Participants will feed on a standard diet only, with no intervention, and complete questionnaires

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Before Brands, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke Clinical Research Institute

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claire Beard

Role: CONTACT

claire.beard@duke.edu

919-660-5689

Facility Contacts

Claire Beard

Role: primary

Other Identifiers

SF-003

Identifier Type: -

Identifier Source: org_study_id