NCT04803981

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

March 15, 2021

Last Update Submit

April 12, 2021

Conditions

Diet DiversityInfant Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

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

    Baseline

  • Diet diversity, score

    12 months

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

    12 months

  • Convenience, score through a questionnaire

    12 months

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

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Standard diet with daily SpoonfulONE

EXPERIMENTAL

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

Standard diet

NO INTERVENTION

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

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.

Standard diet with daily SpoonfulONE

Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27701, United States

RECRUITING

Central Study Contacts

Claire Beard

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 18, 2021

Study Start

April 9, 2021

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

US(1)