Actively Recruiting

Phase Not Applicable
Age: 0 - 12Months
All Genders
Healthy Volunteers
ID06266689

Effects of Diet Data Return on Human Dietary Patterns in Infants and Children

Led by Duke University · Updated on 2026-01-29

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how returning personalized diet data affects eating habits, gut microbiome structure and function, and overall health. The study includes infants, children, and adults, focusing especially on infants participating in Project HOPE 1000, which follows mothers and infants from pregnancy through early childhood. The goal is to see if receiving diet data based on stool sample analysis encourages healthier eating patterns. Participants are randomly assigned to one of two groups. One group receives standard infant dietary guidance plus a report on their infant's dietary DNA data from stool samples, delivered electronically or by mail. The other group gets only the standard dietary guidance for children aged 12-24 months via mail or email, with personalized diet information provided only at the study's end. Stool samples are collected before and after the intervention to assess dietary changes. During the study, caregivers collect and ship infant stool samples for diet analysis. Researchers measure improvements in diet and increases in dietary diversity at 12 months, as well as changes in the gut microbiome's composition and function. Participants will be followed for up to 12 months, with data collected through reports and sample assessments. The study poses minimal risk beyond potential privacy concerns.

CONDITIONS

Brief Title

Project humAn dieTary daTa rEtuRN

Who Can Participate

Age: 0 - 12Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant's parent/legal guardian is over age 18 and able to understand English
  • Plans to remain in the area for the next two years
  • Primary caregiver for infant less than 12 months old
  • Able to collect and ship the requested infant stool samples
Not Eligible

You will not qualify if you...

  • Health conditions that impact the infant feeding in a way that may confound interpretation of study results
  • Conditions that place the infant at unacceptable risk of injury or confound data interpretation, as determined by investigators or providers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Outpatient Treatment

Duration - Up to 24 months

Participants receive standard infant dietary guidance, with some receiving additional personalized diet information based on their infant's dietary DNA data to see if it influences feeding choices.

Visits at 12, 18, and 24 months

Long-term Monitoring

Duration - Up to 12 months following intervention

Participants are observed to assess changes in infant dietary patterns and gut microbiome composition over time.

Follow-up visits aligned with outpatient treatment visits

Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

L

Lawrence A David, PhD

K

Kirsten Jenkins, B.S

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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