Assessing and Addressing Community Exposures to Environmental Contaminants

Environmental Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315140
• Other study ID #: 22-00248
• Secondary ID: 1R01ES033545-015
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: April 2027

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Judith T. Zelikoff, PhD
• Phone: 646-754-9451
• Email: Judith.zelikoff[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Environmental Exposure

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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