RECRUITING

Project humAn dieTary daTa rEtuRN

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Diet Data Return on Human Dietary Patterns

Quick Facts

Study Start:2024-02-27
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06266689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 12 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant's parent/legal guardian is over age 18 and able to understand English
  2. * Plans to remain in the area for the next two years
  3. * Primary caregiver for infant less than 12 months old
  4. * Able to collect and ship the requested infant stool samples
  1. * Health conditions that impact the infant feeding in a way that may confound interpretation of study results.

Contacts and Locations

Study Contact

Lawrence A David, PhD
CONTACT
(919) 668-5388
lawrence.david@duke.edu
Veronica Carrion, B.S
CONTACT
9196607341
veronica.carrion@duke.edu

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-02-27
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Diet Habit