Heartmatters Challenge - First Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of this protocol is to observe whether providing the first responder population with a multi-tiered therapeutic lifestyle modification program, including regular blood testing, diet and telephonic lifestyle coaching, daily food journaling using web-based tools and smartphone apps can lead to positive changes in behavior, resulting in improvements in blood based markers of risk of cardiovascular disease (CVD) as well as improvements in weight and waist circumference.
详细描述
A cluster randomization of first responder communities in the metro Boston and metro Phoenix areas was performed. First responders attended a one hour lecture on the specific risks of CVD in that population and then qualified intervention candidates were enrolled into a lifestyle program, consisting of telephone-based coaching sessions with a registered dietitian and an online/app based food journaling program. Both groups had blood test draws at baseline, 3, 6 and 12 months. The intervention group met with the team practitioner to review results and progress after each blood draw. The test panel comprised blood-based markers of CVD risk associated with lipid metabolism, metabolics, inflammation and basic liver and kidney function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low apolipoprotein A-1 (apoA-1) levels in the very large alpha-1 HDL particle (<20 mg/dL for men, <30 mg/dL for women) OR increased waist size (at least 40 inches for men or 35 inches for women).
- •Internet access
- •14 day food log completed prior to initiating the study intervention (or 3-day food log for the control group).
排除标准
- •No insulin-requiring diabetes
- •No pregnancy or plans to get pregnant in next 12 months
- •Unable or unwilling to follow protocol
- •Unavailable for duration of study
- •Planning to change jobs during study term
结局指标
主要结局
Weight loss
时间窗: 12 months
Change in weight from baseline measurement
Increase in large HDL subparticles
时间窗: 12 months
Change in concentration of large HDL particles measured by 2Dimensional gel electrophoresis
Reduction in waist circumference
时间窗: 12 months
Change in waist circumference from baseline measurement
次要结局
- Improvements in blood based markers of CVD risk(12 months)