Clinical trial

"F!reF!ghterF!t": Lifestyle Coaching Interventions for Obese Firefighters (FireFit)

Opening soon · Not applicable · 1 countries · Registry ID NCT06890975

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexMale
Healthy volunteersNot accepted
ConditionObesity and Obesity-related Medical Conditions

Full registry criteria

Inclusion Criteria: * Male firefighters aged 18-60 years * Currently active as volunteer or career firefighters * Body mass index (BMI) ≥30 kg/m² based on self-reported height and weight * Express interest in participating in a clinical study aimed at improving body composition (weight loss), metabolic status, and quality of life * Residing and/or working in Massachusetts, Rhode Island, or Southern New Hampshire (Boston metro area) Exclusion Criteria: * Female sex\* * BMI \<30 kg/m² based on self-reported height and weight * Active psychosis * History or diagnosis (during the RCT) of any of the following: 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) * Current or recent (within 6 months) use of testosterone treatment or anti-obesity/obesogenic medications * Unwillingness to adhere to 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.

Treatments and study arms

Lifestyle Coaching

Behavioral

The schedule for the individual and group coaching sessions is summarized below: * Individual Coaching: Six one-on-one online sessions with a trained dietician, starting with an initial 30-minute session at baseline, followed by sessions at one month and then every other month. * Group Coaching: 60-minute group online sessions with up to 15 participants per group. Group sessions schedule: there will be a total of 13 group sessions. They will meet once a week for the first 4 weeks, twice monthly for the next 8 weeks of follow-up, and then monthly for the remaining follow-up until the 13th session.

Primary outcomes

Mean change in body mass indexFrom the start of the intervention to its conclusion at nine months.

Body Mass Index (kg/m-squared)

Mean change in body fatFrom the start of the intervention to its conclusion at nine months.

Body fat percentage as measured by bioelectrical impedance

Mean change in waist circumferenceFrom the start of the intervention to its conclusion at nine months.

Waist circumference (cm)

Mean change in waist/hip ratioFrom the start of the intervention to its conclusion at nine months.

Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cambridge Health Alliance🇺🇸 Sommerville, Massachusetts, United States
Patricia LenehanContact
Stefanos N Kales, MDPrincipal Investigator