Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Trial
Condition: Lung Injury; Particulate Matter Inhalation Injury
MeSH terms: Lung Injury; Wounds and Injuries
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): Low-Calorie Mediterranean Diet; Technology based monitoring and behavioral participation; Usual care group
Intervention type(s): Dietary Supplement; Combination Product; Other
Intervention description(s): 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 participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary; Control group, who will receive no dietary or behavioral intervention during the trial
Other intervention name(s): LoCalMed; LoCalMed; Control group
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry
        criteria.
      
Biospecimen description: 
      FEV1<LLN to define WTC-LI; resistant subjects had an FEV1>= LLN at all timepoints post 9/11.
    
Keywords: World Trade Center; Firefighters; FDNY; 9/11; Metabolomics; FIREHOUSE