"F!reF!ghterF!t": a Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters

Phase

N/A

Condition

Diabetes Prevention

Obesity

Treatment

Lifestyle Coaching

Clinical Study ID

NCT06890975

CHA-IRB-23-24-340

Ages 18-60
Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

males aged 18-60 years who are currently active as volunteer or career firefighters,have a BMI of 30 kg/m² or greater based on self-reported height and weight, andexpress interest in participating in a study of clinical interventions aimed atimproving body composition (weight loss), metabolic status, and quality of life. Wewill recruit participants from Massachusetts, Rhode Island, and Southern NewHampshire, which are part of the Boston metro area.

Exclusion

Exclusion Criteria:

females*, BMI less than 30 kg/m² based on self-reported height and weight, activepsychosis, and a history or diagnosis during the RCT of a major CVD event (myocardial infarction, cardiac arrest, or cerebrovascular accident); cancer (exceptnon-melanoma skin cancer); abnormal liver function (aminotransferase, bilirubin, oralkaline phosphatase ≥3 times the upper limit of normal) or renal function (estimated glomerular filtration rate ≤30 mL/min per 1.73 m²); testosteronetreatment; use of anti-obesity (or obesogenic) drugs within the past 6 months; andunwillingness to follow the potential intervention assignments.
Because this is an exploratory study, the number of subjects is limited, andmen make up roughly 85% of the US fire service, the current proposal is limitedto men. In future studies, we will include women firefighters.

Study Design

Lifestyle Coaching

January 21, 2025

January 31, 2026

Study Description

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.

Connect with a study center

Cambridge Health Alliance
Sommerville, Massachusetts 02145
United States
Active - Recruiting

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