Firefighter Collaborative Research Project
FCRP
1 other identifier
interventional
1,500
1 country
7
Brief Summary
The goal of this research is to test interventions to reduce firefighter cardiovascular, cognitive, and overall disease risks, including but not limited to risks associated with Per- and Polyfluorinated Substances (PFAS) exposure. Approximately 1,500 - 2,000 firefighters will be enrolled in the Fire Fighter Cancer Cohort Study (FFCCS). Among these individuals, those that express interest will then be screened for eligibility for the Firefighter Collaborative Research Project (FCRP) using information they provided for the Fire Fighter Cancer Cohort Study. Firefighters enrolled in the study will provide an initial blood sample and urine sample. The blood sample will be analyzed to determine the participant's PFAS levels. Based upon serum PFAS levels and responses from the screening survey, eligible participants will be randomly assigned into one of the following interventions: 1. Blood Donation, or Plasma Donation or Blood/Plasma Control Group; 2. Zone 2 Training or Zone 2 Control; 3. Intermittent Fasting or Intermittent Fasting Control. Individuals participating in the blood donation, plasma donation or blood/plasma control group would donate blood every 12 weeks, plasma every 6 weeks, or not donate blood or plasma. Participants in this intervention arm would continue this for a 12-month period. Individuals in the zone 2 training, zone 2 training control, intermittent fasting or intermittent fasting control group would participate in their intervention or control for a 4-month period. After 4 to 12 months participating in an intervention or control group, participants will be asked to provide a final urine sample and blood draw to determine if and to what degree their PFAS levels or other cardiovascular disease and other health risks have changed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 4, 2025
January 1, 2025
2.5 years
April 24, 2023
May 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in concentration of PFAS levels in serum
PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample
12 months
Change in epigenetic age
Epigenetic age is a mathematically derived age estimators that are based on combinations of methylation values that change with age at specific CpGs in the genome.
4 months
Study Arms (7)
Blood Donation
ACTIVE COMPARATORPlasma Donation
ACTIVE COMPARATORBlood/Plasma Control
PLACEBO COMPARATORZone 2 Training
ACTIVE COMPARATORIntermittent Fasting
ACTIVE COMPARATORZone 2 Control
PLACEBO COMPARATORIntermittent Fasting Control
PLACEBO COMPARATORInterventions
Participants asked to donate whole blood at a donation facility from a list provided by the study.
Participants asked to donate plasma at a donation facility from a list provided by the study.
Participants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes.
Participants asked to engage in an intermittent fasting routine of a 16 hour fast followed by an 8 hour eating period at least 4 times a week.
Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data.
Eligibility Criteria
You may qualify if:
- Active firefighter (including emergency medical responder and all firefighter subgroups) with either a volunteer or career status
- Individual plans to remain in active service with their current agency for the next 2 years (not planning to retire or resign)
- years of age and older
- Fluently speak and write in English
- All sexes, races, and ethnicities
- Enrolled in the Fire Fighter Cancer Cohort Study (FFCCS) prior to enrolling in the Firefighter Collaborative Research Project (FCRP)
- Complete a signed and dated informed consent document that indicates the participant has been informed of all aspects of the study prior to enrollment
- Agree to avoid participating in FCRP intervention activities outside of their assigned intervention group for the duration of the study
- Able to comply with scheduled visits, laboratory tests and other study procedures
- BMI of 17.5 kg/m2 or greater and be greater than 115 pounds
- Must also be eligible to donate blood and blood-based products if randomized into the blood or plasmapheresis intervention groups
You may not qualify if:
- Not able to fluently speak or write in English
- Less than 18 years of age
- Currently a tobacco smoker or vaping (e.g. \>2 cigarettes or cigars, or incidents of vaping in the past month)
- Those with planned travel or extended leave (e.g. \>6 weeks) that would prevent their ability to participate in other interventions
- Those who are pregnant, breastfeeding, or have given birth within the past year
- Those with a history or diagnosis of any significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological disorders, severe injury or cancer that, in the opinion of the investigator, would potentially put the candidate at risk.
- Those with PFOS levels \<5 ng/ml
- Those with any medical contraindication (medical condition or medication) to blood donation
- Those that donated blood or plasma in the past three months
- Those knowing they have a condition indicative of levels of hemoglobin, hematocrit, red blood cells, or iron below the lower limit of normal levels
- Those with a history or diagnosis of diabetes, hypoglycemia thyroid disease, and/or an eating disorder
- Those who recently participated in intermittent fasting or Time Restricted Eating
- Those that recently used antidiabetic medication such as Semaglutide (sold as Ozempic, Wegovy, and Rybelsus) or Tirzepatide (sold as Mounjaro) for the treatment of type 2 diabetes or for weight loss will also be excluded from this group.
- Use of drugs that might affect intermittent fasting or eating behaviors
- Those outside of the state of Arizona
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Arizona State Universitycollaborator
Study Sites (7)
Gilbert Fire & Rescue Department
Gilbert, Arizona, 85295, United States
Green Valley Fire
Green Valley, Arizona, 85622, United States
Tucson Fire Department Headquarters
Tucson, Arizona, 85701, United States
Tucson Fire Department Station 9
Tucson, Arizona, 85711, United States
University of Arizona
Tucson, Arizona, 85719, United States
Northwest Fire District
Tucson, Arizona, 85743, United States
Drexel Heights Fire
Tucson, Arizona, 85746, United States
Related Publications (1)
Conner R, Porter C, Lutrick K, Beitel SC, Hollister J, Healy O, Kern KJ, Wardenaar F, Gulotta JJ, Jack K, Huentelman M, Burgess JL, Furlong M. Interventions to Reduce Serum Per- and Poly-Fluoroalkyl Substances Levels, Improve Cardiovascular Risk Profiles, and Improve Epigenetic Age Acceleration in US Firefighters: Protocol for Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 16;14:e67120. doi: 10.2196/67120.
PMID: 40239196DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 22, 2023
Study Start
June 22, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 4, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share