Cambridge Health Alliance
Sommerville, Massachusetts, 02145, United States
NCT Number: NCT06890975
Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up & sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.
Trial opening soon.
Get Notified18 year–60 year
Male
Interventional
Not applicable
Sommerville, Massachusetts, 02145, United States
RATIONALE/GOALS: Obesity is a major health hazard in the US fire service. It contributes to excess cancer, cardiovascular disease and behavioral health issues. Obesity is negatively associated with 12/13 health priorities identified by the National Fallen Firefighter Foundation. Mitigating obesity is crucial to the fire service's goals of reducing chronic diseases and their adverse economic/operational impacts.
METHODS: At least 75 male firefighters self-reporting a body mass index (BMI) of >/= 30 kg/m2 AND interest in weight loss will complete a baseline health assessment including: lifestyle scores, body composition, metabolic/hormonal indices, physical fitness, and behavioral health screens, until 50 eligible firefighters have been consented and enrolled. After the initial clinical evaluation, 50 eligible firefighters will be randomized into the two study groups (about 25 firefighters to each arm): 1. General Health Instructions (CONTROL) and 2. Individual & Group Lifestyle Coaching based on the six pillars of Lifestyle Medicine & Full Plate Living. Participants will repeat the all health/fitness measures at 3-, 6- and 9-months post study entry. The two treatment groups will be compared on an intention to treat basis.
ANTICIPATED OUTCOMES: Compared to CONTROL, firefighters receiving the Lifestyle Coaching Intervention should achieve significantly greater improvements in body composition, metabolic & other health measures, as well as adopt healthy lifestyle behaviors.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Major cardiovascular disease event (e.g., myocardial infarction, cardiac arrest, cerebrovascular accident) Cancer (excluding non-melanoma skin cancer) Abnormal liver function (aminotransferase, bilirubin, or alkaline phosphatase ≥3× the upper limit of normal) Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m²)
The schedule for the individual and group coaching sessions is summarized below:
Time frame: From the start of the intervention to its conclusion at nine months.
Body Mass Index (kg/m-squared)
Time frame: From the start of the intervention to its conclusion at nine months.
Body fat percentage as measured by bioelectrical impedance
Time frame: From the start of the intervention to its conclusion at nine months.
Waist circumference (cm)
Time frame: From the start of the intervention to its conclusion at nine months.
Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)
Time frame: From the start of the intervention to its conclusion at nine months.
Number (%) of participants with 3 or more metabolic syndrome components
Time frame: From the start of the intervention to its conclusion at nine months.
1-minute push-up capacity
Time frame: From the start of the intervention to its conclusion at nine months.
1-munute sit to stand completions
Time frame: From the start of the intervention to its conclusion at nine months.
Score based on self-reported health behaviors from a standardized survey tool with validated component metrics
Time frame: From the start of the intervention to its conclusion at nine months.
Score based on the validated Short Form-12 Health Survey (SF-12). The SF-12 generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), each ranging from 0 to 100. Higher scores indicate better health-related quality of life.
Cambridge Health Alliance
Other
"F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
Acronym: FireFit
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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