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临床试验/NCT02760628
NCT02760628已完成不适用

A Clinic and Tech-Based Diet and Fitness Intervention for Volunteer Firefighters

National Development and Research Institutes, Inc.4 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2015年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
198
试验地点
4
主要终点
Body Fat

研究概览

简要总结

The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and practices. The program was designed by FFs with backgrounds in tactical fitness, marketing and program development professionals, and nutrition and exercise scientists. Preliminary data suggests the program is well-received by FFs and results in significant improvement in body composition and physical fitness. One innovative approach for the eventual dissemination of TF20 to VFFs is through their fitness-for duty medical exams. The synergy created by linking the TF20 intervention components, feedback to the VFFs from their medical exam, and health messages from their physician is predicted to maximize the impact of this much-needed intervention. The goal of the proposed project is to tailor TF20 for use in a clinic based setting (CB-TF20) for VFFs and to pilot test it in comparison to the American Heart Association's Life's Simple 7 (LS7), a web-based diet and physical activity knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative research with key stakeholders in the VFF community (e.g., physicians, department leadership, VFFs) to determine best practices for implementing a clinic-based, web-mobile health and wellness program with VFFs and medical providers; 2) Develop a clinic-based version of TF20 (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm, pilot cluster (i.e., department) randomized clinical trial (PCRCT) to determine the comparative effectiveness of the revised CB-TF20 to LS7 on body composition, Framingham Risk Scores, and diet/physical activity knowledge and behaviors among VFF with BMI >25.0kg/m2; and conduct an evaluation of the CB-TF20 materials and technology. This innovative R34 study is a critical step in providing a much needed intervention for VFFs and those providing their annual examinations.

详细描述

The US fire service serves as the front line of defense against any domestic emergency and volunteer firefighters comprise the majority of firefighters, often with negative consequences for the health of personnel. While rates of overweight and obesity remain high among firefighters and cardiovascular disease remains the leading cause of line of duty deaths, few resources tailored to the unique culture and needs of firefighters are available to help occupational medicine physicians who provide their fitness for duty examinations. By engaging firefighters and occupational medicine clinicians in tailoring an internet/mobile intervention and pilot testing the program with a sample of volunteer firefighters, the investigators will be poised to implement a full-scale clinical trial with the developed program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to complete all assessments
  • Internet accessibility via computer, tablet or smartphone and ability to use devices appropriately
  • Medically cleared to participate in the program through clinicians
  • ≥18 years

排除标准

  • Not meeting inclusion criteria

研究组 & 干预措施

The First Twenty (TF20)

Experimental

Participants in TF20 will be provided an online wellness program focused on fitness and nutrition tailored to firefighters. TF20 is interactive and involves health coaching.

干预措施: The First Twenty (TF20) (Behavioral)

Life Simple Seven (LS7)

Placebo Comparator

Participants assigned to the LS7 arm will be directed to a website that contains information about health and wellness from the American Heart Association that was developed for the general population. No health coaching is present and the site is not tailored for the fire service.

干预措施: Life Simple 7 (LS7) (Behavioral)

结局指标

主要结局

Body Fat

时间窗: 6 months

Body fat as measured by foot-to-foot bio-electrical impedance

次要结局

  • Framingham Risk Score(6 months)
  • Body Mass Index (BMI)(6 months)
  • Waist circumference(6 months)

研究者

发起方
National Development and Research Institutes, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (4)

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