Obesity and Obesity-related Medical ConditionsFireFitNCT06890975
"F!reF!ghterF!t": Lifestyle Coaching Interventions for Obese Firefighters (FireFit)
A study testing Lifestyle Coaching in people with Obesity and Obesity-related Medical Conditions, run by Cambridge Health Alliance at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Lifestyle Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cambridge Health Alliance
Sommerville, Massachusetts, 02145
Patricia Lenehan, 617-665-1580, elidoriki@challiance.org
Stefanos N Kales, MD
About this study
Official title: "F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
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.
Read the 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.
- Being tested
- Lifestyle Coaching
- Keywords
- obesity, firefighters, diabetes mellitus, coaching, healthy lifestyle, lifestyle medicine, metabolic syndrome, quality of life, mental health, physical fitness
- Medical subject headings
- Obesity, Diabetes Mellitus, Metabolic Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in body mass index
Body Mass Index (kg/m-squared)
Measured: 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
Measured: From the start of the intervention to its conclusion at nine months.
Mean change in waist circumference
Waist circumference (cm)
Measured: 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)
Measured: From the start of the intervention to its conclusion at nine months.
Secondary outcomes (5)
Prevalence of Metabolic Syndrome
Number (%) of participants with 3 or more metabolic syndrome components
Measured: From the start of the intervention to its conclusion at nine months.
Push-up capacity
1-minute push-up capacity
Measured: From the start of the intervention to its conclusion at nine months.
Sit/stand capacity
1-munute sit to stand completions
Measured: From the start of the intervention to its conclusion at nine months.
Self-reported Healthy Lifestyle Score
Score based on self-reported health behaviors from a standardized survey tool with validated component metrics
Measured: From the start of the intervention to its conclusion at nine months.
Self-reported quality of life
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.
Measured: From the start of the intervention to its conclusion at nine months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start21 Apr 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Health Coaching versus written lifestyle instructions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Ardmore Institute of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890975
- Sponsor's protocol ID
- CHA-IRB-23-24-340
- Acronym
- FireFit
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and data-use restrictions
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
- ClinicalTrials.gov ID
- NCT06890975
- Acronym / sponsor ID
- FireFit / CHA-IRB-23-24-340
- Keywords
- obesity, firefighters, diabetes mellitus, coaching, healthy lifestyle, lifestyle medicine, metabolic syndrome, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- Ardmore Institute of Health
- Study start
- 21 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Health Coaching versus written lifestyle instructions
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Lifestyle CoachingThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle CoachingThe 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. | Behavioural | Individual & Group Lifestyle Medicine-based Coaching |
Primary outcome
Mean change in body mass index
Time frame: From the start of the intervention to its conclusion at nine months.
Body Mass Index (kg/m-squared)
Mean change in body fat
Time frame: From the start of the intervention to its conclusion at nine months.
Body fat percentage as measured by bioelectrical impedance
Mean change in waist circumference
Time frame: From the start of the intervention to its conclusion at nine months.
Waist circumference (cm)
Mean change in waist/hip ratio
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)
5 secondary outcomes
Prevalence of Metabolic Syndrome
Time frame: From the start of the intervention to its conclusion at nine months.
Push-up capacity
Time frame: From the start of the intervention to its conclusion at nine months.
Sit/stand capacity
Time frame: From the start of the intervention to its conclusion at nine months.
Self-reported Healthy Lifestyle Score
Time frame: From the start of the intervention to its conclusion at nine months.
Self-reported quality of life
Time frame: From the start of the intervention to its conclusion at nine months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and data-use restrictions
Related trials for Obesity and Obesity-related Medical Conditions
Recruiting
Transition to Ambulatory Bariatric Surgery (TABS) Trial
Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Active, not recruitingEarly Phase 1
Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Obesity and Obesity-related Medical Conditions
Recruiting
A Wearable Device and AI-Supported Diet and Exercise Intervention
Obesity and Obesity-related Medical Conditions
Recruiting
Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)
Appetite, Obesity and Obesity-related Medical Conditions
Active, not recruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
Obesity and Obesity-related Medical Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Coaching in people with Obesity and Obesity-related Medical Conditions, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in body mass index (time frame: From the start of the intervention to its conclusion at nine months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.