Clinical trial NCT06890975: "F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
Official title: "F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Keywords: obesity
firefighters
diabetes mellitus
coaching
healthy lifestyle
lifestyle medicine
metabolic syndrome
quality of life
mental health
physical fitness
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: Ardmore Institute of Health
First posted: 2025-03-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Health Coaching versus written lifestyle instructions
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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, and express interest in participating in a study of clinical interventions aimed at improving body composition (weight loss), metabolic status, and quality of life. We will recruit participants from Massachusetts, Rhode Island, and Southern New Hampshire, which are part of the Boston metro area.

Exclusion Criteria:

* females\*, BMI less than 30 kg/m² based on self-reported height and weight, active psychosis, and a history or diagnosis during the RCT of a major CVD event (myocardial infarction, cardiac arrest, or cerebrovascular accident); cancer (except non-melanoma skin cancer); abnormal liver function (aminotransferase, bilirubin, or alkaline phosphatase ≥3 times the upper limit of normal) or renal function (estimated glomerular filtration rate ≤30 mL/min per 1.73 m²); testosterone treatment; use of anti-obesity (or obesogenic) drugs within the past 6 months; and unwillingness to follow the potential intervention assignments.

  * Because this is an exploratory study, the number of subjects is limited, and men make up roughly 85% of the US fire service, the current proposal is limited to men. In future studies, we will include women firefighters.

Primary outcomes:
measure: Mean change in body mass index
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Mean change in body fat
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Mean change in waist circumference
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Mean change in waist/hip ratio
timeFrame: From the start of the intervention to its conclusion at nine months.
Secondary outcomes:
measure: Prevalence of Metabolic Syndrome
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Push-up capacity
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Sit/stand capacity
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Self-reported Healthy Lifestyle Score
timeFrame: From the start of the intervention to its conclusion at nine months.
measure: Self-reported quality of life
timeFrame: From the start of the intervention to its conclusion at nine months.
Other outcomes:
Locations:
city: Sommerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
References: