Assessing and Addressing Community Exposures to Environmental Contaminants

NCT06315140 | Recruiting

• 3 other identifiers: 22-002481R01ES033545-015R01ES033545-02
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Environmental Exposure

Keywords

Ramapough Nation; metals; food; nutrition

Outcome Measures

Primary Outcomes (5)

• Proportion of individuals with heavy metal contaminants in home water samples

  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

  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

  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

  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

  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

Study Arms (1)

Ramapough Lunaape Nation

EXPERIMENTAL

The tribe will be provided with nutrition-rich foods and recipes for nutritious cooking.

Other: Nutrition

Interventions

Nutrition OTHER

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.

Ramapough Lunaape Nation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Judith Zelikoff, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith T. Zelikoff, PhD

CONTACT

646-754-9451; Judith.zelikoff@nyulangone.org

Erica Pratt

CONTACT

646-754-9447; erica.pratt@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: February 16, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)