An interventional study of Lifestyle Coaching in Obesity and Obesity-related Medical Conditions, sponsored by Cambridge Health Alliance. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 50 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Major cardiovascular disease event (e.g., myocardial infarction, cardiac arrest, cerebrovascular accident) Cancer (excluding non-melanoma skin cancer) Abnormal liver function (aminotransferase, , or alkaline phosphatase ≥3× the ) Renal dysfunction (estimated ≤30 mL/min/1.73 m²)
Unwillingness to adhere to potential intervention assignments
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
Mean change in body mass index
Body Mass Index (kg/m-squared)
Time frame: 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
Time frame: From the start of the intervention to its conclusion at nine months.
Mean change in waist circumference
Waist circumference (cm)
Time frame: 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)
Time frame: From the start of the intervention to its conclusion at nine months.
Prevalence of Metabolic Syndrome
Number (%) of participants with 3 or more metabolic syndrome components
Time frame: From the start of the intervention to its conclusion at nine months.
Push-up capacity
1-minute push-up capacity
Time frame: From the start of the intervention to its conclusion at nine months.
Sit/stand capacity
1-munute sit to stand completions
Time frame: 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
Time frame: 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.
Time frame: From the start of the intervention to its conclusion at nine months.
Plan to share: No — IPD will not be shared due to privacy concerns and data-use restrictions
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Oct 2026, 6 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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