- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03581006
Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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
Other Names:
Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary
Other Names:
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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. |
Control group, who will receive no dietary or behavioral intervention during the trial
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index (BMI)
Time Frame: 4 Years
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Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m^2
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4 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary Function using FEV Measure
Time Frame: 4 Years
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Forced expiratory volume (FEV) using spirometer that measures the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
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4 Years
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St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 4 Years
|
Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.
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4 Years
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Electrocardiogram (EKG)
Time Frame: 4 years
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Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest
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4 years
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Fraction of exhaled nitrous oxide (FENO)
Time Frame: 4 years
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Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.
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4 years
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Pulse Wave Velocity (PWV)
Time Frame: 4 years
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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.
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4 years
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Individual microbiome profile - stool sample
Time Frame: 4 years
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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.
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4 years
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6-minute walk test (6MWT)
Time Frame: 4 years
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Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.
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4 years
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Individual metabolomic profile - blood sample
Time Frame: 4 years
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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.
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4 years
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Individual genomic profile - saliva sample
Time Frame: 4 years
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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.
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4 years
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Short-form-36 (SF-36) questionnaire
Time Frame: 4 years
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Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life
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4 years
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Routine vital signs - Heart Rate
Time Frame: 4 years
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Brief assessment of heart rate (pulse) measured in beats/per minute
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4 years
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Routine vital signs - Blood Pressure
Time Frame: 4 years
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Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.
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4 years
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Routine vital signs - Body temperature
Time Frame: 4 years
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Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit
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4 years
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Neck circumference
Time Frame: 4 years
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Assessment of neck circumference using basic measuring tape, recorded in centimeters
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4 years
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Waist circumference
Time Frame: 4 years
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Assessment of waist circumference using basic measuring tape, recorded in centimeters
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4 years
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Bioelectrical impedance analysis (BIA)
Time Frame: 4 years
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Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.
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4 years
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Food Frequency Questionnaire
Time Frame: 4 years
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Paper assessment of typical dietary intake over previous one month, multiple choice answers
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4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Nolan, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-00127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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