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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 18 months

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

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age cutoff for participants exceed 25 years old?

"This research project is seeking participants who are between 4 and 6 months of age."

Answered by AI

What criteria must individuals meet to qualify for this research endeavor?

"Eligible participants must have a varied diet and be at least 4 months old, but no older than 6. In total, 1500 individuals are being recruited for the trial."

Answered by AI

Is the enrollment process available for the experiment still ongoing?

"At this time, clinicaltrials.gov reveals that the study is recruiting for participants. This investigation was first advertised on April 9th 2021 and had a follow up edit on April 12th of the same year."

Answered by AI

To what extent are individuals participating in this research endeavor?

"Affirmative. The clinicaltrials.gov website confirms that this medical trial, initially posted on April 9th 2021, is still recruiting participants to join the study. 1500 patients have been allocated one location for their participation in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)

2021. "Infancy to Toddlerhood: Early Nutrition & Tolerance (INTENT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803981.