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

NCT06890975 | Not Yet Recruiting

• 1 other identifier: CHA-IRB-23-24-340
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Mean change in body mass index

  Body Mass Index (kg/m-squared)

  From the start of the intervention to its conclusion at nine months.

• Mean change in body fat

  Body fat percentage as measured by bioelectrical impedance

  From the start of the intervention to its conclusion at nine months.

• Mean change in waist circumference

  Waist circumference (cm)

  From the start of the intervention to its conclusion at nine months.

• Mean change in waist/hip ratio

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

  From the start of the intervention to its conclusion at nine months.

Secondary Outcomes (5)

• Prevalence of Metabolic Syndrome

  From the start of the intervention to its conclusion at nine months.

• Push-up capacity

  From the start of the intervention to its conclusion at nine months.

• Sit/stand capacity

  From the start of the intervention to its conclusion at nine months.

• Self-reported Healthy Lifestyle Score

  From the start of the intervention to its conclusion at nine months.

• Self-reported quality of life

  From the start of the intervention to its conclusion at nine months.

Study Arms (2)

Control/ General Written Health Instructions

NO INTERVENTION

Participants will receive standard lifestyle recommendations, consisting of two pages of written information summarized from the American Heart Association's 'Healthy for Good' webpages for the general public. These will include guidance on healthy diets, physical activity, healthy sleep, stress reduction, and avoiding tobacco, excess alcohol, and other harmful substances.

Individual & Group Lifestyle Medicine-based Coaching

ACTIVE COMPARATOR

This group will receive personal and group coaching sessions based on the six pillars of lifestyle medicine: 1) a plant- predominant eating pattern (consistent with the AIH "Full Plate Living" program); 2) physical movement; 3) restorative sleep; 4) management of stress; 5) avoidance of risky substances; and 6) positive social connections. Target goals for the participants assigned to Lifestyle Coaching will include the following: improving diet quality together with moderate caloric restriction; engaging in more physical activity with a goal of 150 minutes or more per week of at least moderate intensity (e.g. brisk walking); getting 7-8 hours of sleep nightly when possible and using short naps when work or other conditions interfere with getting at least 7 hours of sleep; increasing resilience and using positive social/family connections to manage/decrease stress.

Behavioral: Lifestyle Coaching

Interventions

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.

Individual & Group Lifestyle Medicine-based Coaching

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• Ardmore Institute of Health: collaborator

Study Sites (1)

Cambridge Health Alliance

Sommerville, Massachusetts, 02145, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Metabolic Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Health Coaching versus written lifestyle instructions

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: April 21, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)