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

NCT03581006 | Completed

• 1 other identifier: 17-00127
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

World Trade Center; Firefighters; FDNY; 9/11; Metabolomics; FIREHOUSE

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• 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

Study Arms (2)

Intervention Group

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.

Dietary Supplement: Low-Calorie Mediterranean Diet; Combination Product: Technology based monitoring and behavioral participation

Control (Usual care) Group

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.

Other: Usual care group

Interventions

Low-Calorie Mediterranean Diet DIETARY_SUPPLEMENT

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

Also known as: LoCalMed

Intervention Group

Technology based monitoring and behavioral participation COMBINATION_PRODUCT

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

Also known as: LoCalMed

Intervention Group

Usual care group OTHER

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

Also known as: Control group

Control (Usual care) Group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Gender Eligibility Details: Male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.

You may qualify if:

• Age 21-90.
• Born male sex and currently identify as genetic male
• FDNY rescue and recovery worker.
• Documented WTC exposure.
• Enrolled in the FDNY WTC Health Program
• Subjects are willing and able to consent for themselves to study enrollment
• Subjects are willing and able to participate in study procedures
• Are able to perform their activities of daily living independently
• Are either light duty or retired FDNY Firefighters
• Have an FEV1 less than the LLN of predicted for age/sex/weight documented at any time after 9/11/2001.
• Have a BMI\>27 kg/m2 and \<50kg/m2
• Willing and able to modify their diet and activity level.
• Subjects who have a spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY
• Demonstrate minimal proficiency using a smart phone
• Have means to accommodate transportation to/from in-person visits

You may not qualify if:

• Have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
• Concomitant use of interfering medication(s) or devices currently or within the month prior to enrollment, including anti-retrovirals, human monoclonal antibodies, supplemental daytime oxygen, and insulin pumps.
• Severe gastrointestinal issues or illnesses that would prevent adherence to the proposed diets.
• Severe kidney disease requiring dialysis
• Severe liver disease requiring frequent medical intervention
• Participating in other diet modification studies.
• High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
• Life-expectancy \< 6 months
• BMI ≥50 kg/m2 or ≤27 kg/m2
• Recent significant intentional or unintentional weight loss, defined as over 5% reduction in total body weight over the last month. (Blackburn Criteria).
• Significant or severe alcohol abuse disorder

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

FEV1\<LLN to define WTC-LI; resistant subjects had an FEV1\>= LLN at all timepoints post 9/11.

MeSH Terms

Conditions

Lung Injury

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anna Nolan, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 10, 2018
• Study Start: November 12, 2018
• Primary Completion: March 4, 2021
• Study Completion: March 4, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

US (1)