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

Официальное название

"F!reF!ghterF!t": A Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Mean change in body mass index [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Mean change in body fat [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Mean change in waist circumference [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Mean change in waist/hip ratio [Срок оценки: From the start of the intervention to its conclusion at nine months.]

Вторичные конечные точки (5)

• Prevalence of Metabolic Syndrome [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Push-up capacity [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Sit/stand capacity [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Self-reported Healthy Lifestyle Score [Срок оценки: From the start of the intervention to its conclusion at nine months.]
• Self-reported quality of life [Срок оценки: From the start of the intervention to its conclusion at nine months.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cambridge Health Alliance — Sommerville

Идентификаторы

NCT: NCT06890975 · CHA-IRB-23-24-340

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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