Sponsor study identifier
observational
100
1 country
1
Study Start
November 12, 2018
Actual (reported)Primary Completion
March 4, 2021
Actual (reported)Study Completion
March 4, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 4, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2018
Actual (reported)July 10, 2018
Actual (reported)November 12, 2018
Actual (reported)March 4, 2021
Actual (reported)March 4, 2021
Actual (reported)Body mass index (BMI)
Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m\^2
4 Years
Pulmonary Function using FEV Measure
4 Years
St. George's Respiratory Questionnaire (SGRQ)
4 Years
Electrocardiogram (EKG)
4 years
Fraction of exhaled nitrous oxide (FENO)
4 years
Pulse Wave Velocity (PWV)
4 years
This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function. This intervention group will undergo technology based monitoring and behavioral participation in a dietary and exercise program with the intent of weight loss and compliance with a low-calorie Mediterranean diet.
This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function. This group will receive no dietary or behavioral intervention. They will continue usual care with their home physicians.
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
FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.
New York University School of Medicine
New York, New York, 10016, United States
FEV1\<LLN to define WTC-LI; resistant subjects had an FEV1\>= LLN at all timepoints post 9/11.
Anna Nolan, MD
NYU Langone Health
100 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2018
First Posted
July 10, 2018
Study Start
November 12, 2018
Actual (reported)Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary
Control group, who will receive no dietary or behavioral intervention during the trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 4, 2021
Actual (reported)Study Completion
March 4, 2021
Actual (reported)Last Updated
December 3, 2021
Record last verified: 2021-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: