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| Name | Class |
|---|---|
| Ardmore Institute of Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Coaching | Behavioral | The schedule for the individual and group coaching sessions is summarized below:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Metabolic Syndrome | Number (%) of participants with 3 or more metabolic syndrome components | From the start of the intervention to its conclusion at nine months. |
| Push-up capacity |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance | Sommerville | Massachusetts | 02145 | United States |
IPD will not be shared due to privacy concerns and data-use restrictions
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Health Coaching versus written lifestyle instructions
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1-minute push-up capacity
| From the start of the intervention to its conclusion at nine months. |
| Sit/stand capacity | 1-munute sit to stand completions | 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 | 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. | From the start of the intervention to its conclusion at nine months. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |