Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06266689

Conditions

Diet Habit

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Personalized Diet Information

Study Details

Brief summary:

This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation.

Conditions

Diet Habit

Study ID

NCT06266689

Start date

Feb 27, 2024

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

There will be no specific exclusions for this study. However, the following biospecimens will not be collected for research purposes from individuals who have a condition that, in the opinion of the site investigators and/or providers, would place the subject at unacceptable risk of injury or confound data interpretation; including but not limited to:

  • Health conditions that impact the infant feeding in a way that may confound interpretation of study results.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Intervention

Participants in this group will receive the standard infant dietary guidance packet via email or mail and will additionally be presented with their infant's own dietary DNA metabarcoding data from stool samples collected as part of Project HOPE 1000 and this study. Diet data will be returned via electronic report or a paper report mailed to the participant following the visit.

other: Control

Participants in this group will receive a dietary information packet via mail or email, which will consist of the sections of the DGA relevant to 12-24 month old children (Included as a supplemental document, "Standard dietary guidance"). This dietary guidance will also be provided at the 18- and 24-month visits. Please note that participants in this arm will receive their personalized diet information at the conclusion of the study.

Interventions

Personalized Diet Information

These participants will receive a report detailing their genomic food data based on the investigators' DNA metabarcoding technique in addition to standard dietary guidance to see if receiving the report modifies what they choose to feed their infant.

Primary outcome measure

  • Number of participants with diet improvement [ Time Frame: 12 months ]
  • Number of participants with increased dietary diversity [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

Duke University

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-01-29.