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

Plain-language summary

This study compares a low-calorie Mediterranean diet with technology-based monitoring against usual care for the health of firefighters exposed to the World Trade Center site. Eligible participants are FDNY rescue and recovery workers aged 21-90 with documented exposure, reduced lung function and a body mass index between 27 and 50 kg/m². It was conducted as a study without a formal phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

NYU Langone Health

Intervention

Low-Calorie Mediterranean Diet, Technology based monitoring and behavioral participation, Usual care group

Start date

11/12/2018

Estimated completion

3/4/2021

Countries

United States

Related genes

Locations

• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. 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.
3. Severe gastrointestinal issues or illnesses that would prevent adherence to the proposed diets.
4. Severe kidney disease requiring dialysis
5. Severe liver disease requiring frequent medical intervention
6. Participating in other diet modification studies.
7. High dose steroid (\>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
8. Life-expectancy \< 6 months
9. BMI ≥50 kg/m2 or ≤27 kg/m2
10. Recent significant intentional or unintentional weight loss, defined as over 5% reduction in total body weight over the last month. (Blackburn Criteria).
11. Significant or severe alcohol abuse disorder