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Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial

NCT03581006 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-12-03

No results posted yet for this study

Summary

This is a randomized-controlled unblinded clinical trial to investigate dietary intervention on metabolic biomarker assessment in World Trade Center (WTC) Lung Injury (LI) in firefighters. The purpose of this study is to evaluate biomarkers of metabolic dysregulation that have previously been found to predict WTC-LI in a case cohort study selected from the entire exposed firefighter cohort, and attempt to alter these metabolites using dietary intervention and a technology-supported behavioral modification program. Investigators will measure Pre/Post global metabolic expression in WTC-exposed, symptomatic firefighter serum sampled after 6-month intervention, as well as clinical outcomes of WTC-LI in the study group vs controls.

Conditions

  • Lung Injury
  • Particulate Matter Inhalation Injury

Interventions

DIETARY_SUPPLEMENT

Low-Calorie Mediterranean Diet

Participants in the intervention group will receive 6 months of education and behavioral counseling with self-monitoring to help them adopt a Mediterranean-style, calorie-restricted diet, and engage in physical activity

COMBINATION_PRODUCT

Technology based monitoring and behavioral participation

Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary

OTHER

Usual care group

Control group, who will receive no dietary or behavioral intervention during the trial

Sponsors & Collaborators

Principal Investigators

  • Anna Nolan, MD · NYU Langone Health

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2021-03-04
Completion
2021-03-04

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03581006 on ClinicalTrials.gov