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Recruiting NCT06315140

Assessing and Addressing Community Exposures to Environmental Contaminants

No phase Interventional Environmental Exposure

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: Nutrition.
Who it may be relevant to
Registry conditions: Environmental Exposure. Basic parameters: 18 years — 80 years · 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 →
Official title

Building Food Sovereignty, Sustainability and Better Health in Environmentally-impacted Native Americans

Overview

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.

Interventions

  • Other Nutrition
    The intervention will build on the 11-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. Working with the Ramapough-leased Munsee Three Sisters Medicinal farm (growing produce/crops on clean soil) will provide the tribe with nutrition-rich foods and recipes for nutritious cooking. The interventions aims to return healthy soil on th

Primary outcome measures

  • Proportion of individuals with heavy metal contaminants in home water samples [Time frame: through study completion, an average 2 years]
  • Proportion of individuals with heavy metal and metalloid contaminations in blood biospecimens [Time frame: through study completion, an average 2 years]
  • Proportion of individuals with heavy metal and metalloid contaminations in urine biospecimens [Time frame: through study completion, an average 2 years]
  • Proportion of individuals with insufficient blood serum micronutrient levels [Time frame: through study completion, an average 2 years]
  • Proportion of individuals with health disorders [Time frame: through study completion, an average 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06315140 · 22-00248 · 1R01ES033545-01 · 5R01ES033545-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗