Assessing and Addressing Community Exposures to Environmental Contaminants

January 27, 2026 updated by: NYU Langone Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

This study aims to recruit individuals from the Ramapough Lenape Tribe to ensure that the benefits and burdens of research participation are distributed towards the intended community. Other non-Native residents in the Ringwood and Mahwah area will be Non-Hispanic Whites, given the demographics of the area.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramapough Lunaape Nation
The tribe will be provided with nutrition-rich foods and recipes for nutritious cooking.
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 the farm allowing for healthy plant production.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of individuals with heavy metal contaminants in home water samples
Time Frame: through study completion, an average 2 years
Outcome measures will be collected using home water samples.
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
Outcomes measures will be evaluated using blood samples from the Ramapough Lunaape Tribe.
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
Outcomes measures will be evaluated using urine samples from the Ramapough Lunaape Tribe.
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
Outcome measures will be evaluated using blood serum from the Ramapough Lunaape tribe.
through study completion, an average 2 years
Proportion of individuals with health disorders
Time Frame: through study completion, an average 2 years
Health status will be assessed using anthropometric measures including blood pressure, body weight, waist circumference, height and Body Mass Index (BMI).
through study completion, an average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Judith Zelikoff, PhD, NYU Langone Health

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 Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-00248
  • 1R01ES033545-01 (U.S. NIH Grant/Contract)
  • 5R01ES033545-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Judith.zelikoff@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Judith.zelikoff@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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