Project humAn dieTary daTa rEtuRN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Diet Information.
- Who it may be relevant to
- Registry conditions: Diet Habit. Basic parameters: up to 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Diet Data Return on Human Dietary Patterns
Overview
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.
Interventions
- Behavioral 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 measures
- Number of participants with diet improvement [Time frame: 12 months]
- Number of participants with increased dietary diversity [Time frame: 12 months]
Secondary outcome measures (1)
- Number of participants with changes in the composition and function of the gut microbiome [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT06266689 · Pro00112671