跳至主要内容
临床试验/NCT02941757
NCT02941757已完成不适用

Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits and Improve Cardiovascular Risk Profiles

Harvard School of Public Health (HSPH)2 个研究点 分布在 1 个国家目标入组 486 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
486
试验地点
2
主要终点
Changes in Mediterranean diet scale

研究概览

简要总结

The purpose of this study is to modify the food culture of the fire service by motivating firefighters and their families to incorporate Mediterranean diet principles at work and home through behavior change strategies that involve education, participation and incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting more firefighters and their families to adopt and incorporate the healthy eating principles behind the Mediterranean diet.

详细描述

Aims and hypothesis:

Recognizing the benefits and safety of the Mediterranean diet in CVD prevention, the investigators seek to develop behavioral change strategies in the fire service to modify the existing food culture based on key principles of the Mediterranean diet. Using education, participation and incentives, the investigators propose to motivate firefighters and their families to incorporate Mediterranean diet principles at work and home. The research design will allow us to measure the effectiveness of our Mediterranean Nutrition Interventions (MDNIs) in the "field settings" of the fire services for changing eating behavior and modifying CVD risk. Additionally, the cost-effectiveness of these strategies for future wider implementation will be examined. Specifics aims are:

  1. Develop a multi-pronged, MDNI behavior change strategies including: diet/lifestyle education; discounted access to key Mediterranean diet foods; electronic education platforms and reminders; and targeted incentives. MDNI components will be refined via surveys, literature review and local/national firefighter input including labor/management and fire service focus groups.

Hypothesis (1). Cost-effective, fire-service MDNIs will be developed for the career randomized controlled trial (RCT). 2. Cluster Randomized Diet Intervention-Phase I- the Indianapolis Fire Department (IFD) has over 1,000 members. All 45 IFD firehouses will be cluster randomized into two groups and then individual members will be consented regarding study participation. Group 1 will receive an active 12-month MDNI, while Group 2 will receive no intervention. 3. Cluster Randomized Diet Intervention -Phase II: Group 1 will cross-over to "self-sustained continuation" for 12 months to examine persistence of behavior change during this less intense, self-directed maintenance diet intervention. Group 2 will cross-over to receive the MDNI for 6 months (assessing a shorter MDNI), followed by a final 6 months of self-sustained continuation. Our existing modified Mediterranean diet score (mMDS) will be further integrated with other validated scores and nutrition questionnaires. Questionnaires, mMDS and clinical data will be collected longitudinally throughout both phases of the RCT.

Hypotheses (2-3). Both MDNI lengths will improve mMDS, reduce weight, and improve Cardiovascular Disease (CVD) risk profiles in career firefighters. The 12 month MDNI will produce greater persistence of adherence than a 6 month MDNI. Cost-effective methods that combine messaging and discounts for improving firefighters' diets will be developed and validated, and these low cost methods will be adaptable for widespread translation and implementation throughout the career fire service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • those permanently assigned to one of the 45 IFD stations
  • with a fire department-provided medical exam in the last two years
  • at least 18 years of age
  • full duty status at the time of consent

排除标准

  • those without a recorded fire department exam in the last two years
  • less than 18 years of age
  • restrictions on duty at the time of consent.

结局指标

主要结局

Changes in Mediterranean diet scale

时间窗: 6, 12, and 24 months

12 months change in the MD scores as well as 12- and 24 month change in group 1; and 6 and 12 month change from baseline to follow up in group 2.

次要结局

  • Changes in biomarkers(6 months)
  • Changes in lipids(24 months)
  • Changes in inflammatory markers(24 months)
  • Changes in BMI (m2/kg)(24 months)
  • Changes in waist circumference (cm)(24 months)
  • Changes in weight (kg)(24 months)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kales Stefanos

Associate Professor

Harvard School of Public Health (HSPH)

研究点 (2)

Loading locations...

相似试验