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SpoonfulONE for Infant Nutrition (INTENT Trial)

N/A
Waitlist Available
Research Sponsored by Before Brands, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months and 18 months
Awards & highlights

INTENT Trial Summary

This trial is designed to study how best to introduce complementary foods to infants, either with or without eczema. Parents will use a mobile app to track their experiences and progress in feeding their infants.

Eligible Conditions
  • Infant Nutrition
  • Diet Variety

INTENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of foods tolerated by participants, measured through a feeding questionnaire, of 5 common foods (peanut, egg, cashew, cod, and sesame)
Secondary outcome measures
Convenience, score through a questionnaire
Diet diversity, score
Mean age of participants when first introduced to various food groups, measured through a questionnaire
+4 more

INTENT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard diet with daily SpoonfulONEExperimental Treatment1 Intervention
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 II: Standard dietActive Control1 Intervention
Participants will feed on a standard diet only, with no intervention, and complete questionnaires

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Who is running the clinical trial?

Before Brands, IncLead Sponsor
Duke Clinical Research InstituteOTHER
63 Previous Clinical Trials
240,032 Total Patients Enrolled
~367 spots leftby Jun 2025
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