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

NCT ID: NCT03581006

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-12

Study Completion Date

2021-03-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Injury Particulate Matter Inhalation Injury

Keywords

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World Trade Center Firefighters FDNY 9/11 Metabolomics FIREHOUSE

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Low-Calorie Mediterranean Diet

Intervention Type 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

Technology based monitoring and behavioral participation

Intervention Type COMBINATION_PRODUCT

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

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.

Usual care group

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Technology based monitoring and behavioral participation

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

Intervention Type COMBINATION_PRODUCT

Usual care group

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

Intervention Type OTHER

Other Intervention Names

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LoCalMed LoCalMed Control group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Nolan, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-00127

Identifier Type: -

Identifier Source: org_study_id