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Lung InjuryNCT03581006

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

An observational study of Lung Injury and Particulate Matter Inhalation Injury, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years, men only
What is being tested?
Low-Calorie Mediterranean Diet and Technology based monitoring and behavioral participation
How many people
100 participants
Where
1 siteUnited States
Study dates
12 Nov 2018to 4 Mar 2021
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

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.

Read the detailed description

Investigators propose to measure metabolites on this expanded cohort with serum sampled before and after 6-month intervention with calorie restricted Mediterranean diet to: 1) determine the effects of a technology assisted calorie restricted diet on metabolic risk and lung function; 2) determine differences between usual care and intervention group using genomics and metabolomics that may be targetable markers for further evaluation; 3) quantify the metabolome and evaluate pre/post changes in BMI, FEV1, FeNo, vascular stiffness, and overall quality of life; and 4) explore dietary modification as treatment of WTC-LI. The biomarker profile of the cohort control will be useful for discovering biomarker associations with other disease manifestations such as: bronchial wall thickening on CT, obstruction on FEV1 /FVC ratio, bronchodilator response, methacholine reactivity, and other definitions of loss of FEV 1 . This cohort control will be an asset to future studies.

Being tested
Low-Calorie Mediterranean Diet, Technology based monitoring and behavioral participation, Usual care group
Keywords
World Trade Center, Firefighters, FDNY, 9/11, Metabolomics, FIREHOUSE
Medical subject headings
Lung Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Calorie Mediterranean DietDietary supplement

    Also called LoCalMed

    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

  • Technology based monitoring and behavioral participationCombination product

    Also called LoCalMed

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

  • Usual care groupOther

    Also called Control group

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

Study groups in NCT03581006
Study groupRoleWhat they receive
Intervention GroupThis 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.
Receives: Dietary Supplement: Low-Calorie Mediterranean Diet; Combination Product: Technology based monitoring and behavioral participation
Control (Usual care) GroupThis 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.
Receives: Other: Usual care group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 Years

Secondary outcomes (17)

  1. Pulmonary Function using FEV Measure

    Forced expiratory volume (FEV) using spirometer that measures the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

    Measured: 4 Years

  2. St. George's Respiratory Questionnaire (SGRQ)

    Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.

    Measured: 4 Years

  3. Electrocardiogram (EKG)

    Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest

    Measured: 4 years

  4. Fraction of exhaled nitrous oxide (FENO)

    Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.

    Measured: 4 years

  5. Pulse Wave Velocity (PWV)

    Non-invasive measurement to ascertain vascular stiffness, by measuring the velocity at which the blood pressure pulse propogates through the circulatory system. This is done using a simple non-invasive blood pressure cuff assessment at the carotid and femoral arteries. It is measured as a velocity, in meters/per second.

    Measured: 4 years

  6. Individual microbiome profile - stool sample

    Simple home collection of a stool sample using a sterile collection kit, provided to the human subject. Stool will be used to generate a microbiome profile unique to that individual, reported as bacterial species found in the gut flora, that may predict lung injury. There is no risk to the human subject aside that of providing a stool sample. All individual information is de-identified for personal protection.

    Measured: 4 years

  7. 6-minute walk test (6MWT)

    Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.

    Measured: 4 years

  8. Individual metabolomic profile - blood sample

    Routine blood testing via sterile phlebotomy to assess metabolic biomarkers that may or may not predict lung injury. These metabolites are generated in all individuals based on their dietary and exercise habits, underlying comorbidities, and unique metabolism. Measured in routine blood samples, and quantified based on unique chemical composition of that molecule. There is no additional risk to the human subject aside that of venipuncture.

    Measured: 4 years

  9. Individual genomic profile - saliva sample

    Simple home collection of sputum/saliva sample using a buccal swab kit, provided to the human subject. Saliva will be used to generate a genetic profile unique to that individual, reported as chromosomes, genes, and proteins that may predict lung injury. There is no risk to the human subject aside that of providing a sputum sample. All individual information is de-identified for personal protection.

    Measured: 4 years

  10. Short-form-36 (SF-36) questionnaire

    Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life

    Measured: 4 years

  11. Routine vital signs - Heart Rate

    Brief assessment of heart rate (pulse) measured in beats/per minute

    Measured: 4 years

  12. Routine vital signs - Blood Pressure

    Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.

    Measured: 4 years

  13. Routine vital signs - Body temperature

    Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit

    Measured: 4 years

  14. Neck circumference

    Assessment of neck circumference using basic measuring tape, recorded in centimeters

    Measured: 4 years

  15. Waist circumference

    Assessment of waist circumference using basic measuring tape, recorded in centimeters

    Measured: 4 years

  16. Bioelectrical impedance analysis (BIA)

    Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.

    Measured: 4 years

  17. Food Frequency Questionnaire

    Paper assessment of typical dietary intake over previous one month, multiple choice answers

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2018
  2. Study start12 Nov 2018
  3. Primary completion4 Mar 2021
  4. Study completion4 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03581006
Sponsor's protocol ID
17-00127
Status last verified
Dec 2021
First submitted
15 Jun 2018
Last updated
3 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Injury and Particulate Matter Inhalation Injury, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (BMI) (time frame: 4 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03581006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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