"F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in body mass index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Control/ General Written Health Instructions
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
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.
干预措施: Lifestyle Coaching (Behavioral)
结局指标
主要结局
Mean change in body mass index
时间窗: From the start of the intervention to its conclusion at nine months.
Body Mass Index (kg/m-squared)
Mean change in body fat
时间窗: 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
时间窗: From the start of the intervention to its conclusion at nine months.
Waist circumference (cm)
Mean change in waist/hip ratio
时间窗: From the start of the intervention to its conclusion at nine months.
Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)
次要结局
- 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.)