1. Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial
- Author
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Mengling Liu, Mena Mikhail, Christine Nayar, Dean Ostrofsky, Mary Ann Sevick, David J. Prezant, George Crowley, Anna Nolan, Jessica Riggs, Isabel R. Young, Mary Lou Pompeii, Arul Veerappan, Rachel Zeig-Owens, Sophia Kwon, Maria Sunseri, Hilary L. Colbeth, Rachel Lam, Theresa Schwartz, and David E. St-Jules
- Subjects
Male ,Mediterranean diet ,Health, Toxicology and Mutagenesis ,lcsh:Medicine ,030204 cardiovascular system & hematology ,Diet, Mediterranean ,law.invention ,Eating ,0302 clinical medicine ,Quality of life ,Randomized controlled trial ,9/11 ,law ,Activities of Daily Living ,Outcome Assessment, Health Care ,030212 general & internal medicine ,Cardiopulmonary disease ,metabolomics ,humanities ,Adult ,medicine.medical_specialty ,New York ,Lung injury ,Pulse Wave Analysis ,complex mixtures ,Article ,metabolic syndrome ,03 medical and health sciences ,Young Adult ,Occupational Exposure ,medicine ,Humans ,lung injury ,particulate matter ,firefighters ,business.industry ,lcsh:R ,Public Health, Environmental and Occupational Health ,biomarkers ,medicine.disease ,World Trade Center ,Clinical trial ,Emergency medicine ,Quality of Life ,New York City ,Metabolic syndrome ,September 11 Terrorist Attacks ,business ,Body mass index - Abstract
Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV1). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI). We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI >, 27 kg/m2 will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)&mdash, an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions, or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV1, fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.
- Published
- 2020
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