Clinical trial NCT06315140: Assessing and Addressing Community Exposures to Environmental Contaminants
Official title: Building Food Sovereignty, Sustainability and Better Health in Environmentally-impacted Native Americans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Environmental Exposure
Keywords: Ramapough Nation
metals
food
nutrition
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2024-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following:

* Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions.
* Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers.
* Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach.


Eligibility criteria: Inclusion Criteria:

* Male or female between the age of 18 - 80 years old at the time of enrollment
* Living on the streets of Halifax Road, Orange Turnpike, Ramapo Ave, 1st-7th Streets, Mountain Avenue and Fox Hollow Road in Hillburn, NY; Peter's Mine Road, Canon Mine Road, Pipeline Road, Milligan Drive, Cable House Road and Van Dunk Lane in Ringwood, NJ; Stag Hill Road, and Ramapo Brae Lane in Mahwah, NJ
* Willing and able to provide consent

Exclusion Criteria:

* Pregnant women and individuals under 18 or over 80 years old
* Do not live in the identified streets above and/or have lived there for less than 2 years will be excluded from the study

Primary outcomes:
measure: Proportion of individuals with heavy metal contaminants in home water samples
timeFrame: through study completion, an average 2 years
measure: Proportion of individuals with heavy metal and metalloid contaminations in blood biospecimens
timeFrame: through study completion, an average 2 years
measure: Proportion of individuals with heavy metal and metalloid contaminations in urine biospecimens
timeFrame: through study completion, an average 2 years
measure: Proportion of individuals with insufficient blood serum micronutrient levels
timeFrame: through study completion, an average 2 years
measure: Proportion of individuals with health disorders
timeFrame: through study completion, an average 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Judith Zelikoff, PhD
role: PRINCIPAL_INVESTIGATOR
References: