Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Composite GHP outcomes health score
研究概览
简要总结
The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program.
The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S.
Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk.
The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.
详细描述
This culturally-tailored intervention program will take place over a 12-month period in the following four regions on the island:
- St. David's Parish
- St. Andrew's Parish
- St. George's Parish
- St. John's/St. Mark's Parish (combined ) •The program will involve approximately 400 randomized participants (100 from each region). Participants, aged 18-70, from each parish will be divided into one of two groups: Intervention Group arm (peer support) or Control Group arm (individual study).
The investigators will identify study participants previously enrolled in the Grenada Heart Project, with at least one vascular risk factor, as defined by the Adult Treatment Panel III guidelines which include: elevated BP, increased blood glucose level, increased waist circumference, minimal reported physical activity, minimally reported fruit and vegetable intake, or current smoking habits. Given a 10% refusal rate and 10% failure rate in the run-in phase, 120 participants from each site will be invited randomly, from the high risk group, to recruit for participation in the study.
All eligible participants are invited to attend an informational half-day session, during which a general overview of the program is presented and participants have an opportunity to have any questions answered. During this session, eligible and interested individuals complete the written consent forms. Upon consenting, participants are informed of their randomization arm (education intervention or group intervention) and entered into a run-in phase. All participants receive a notebook, as well as certain health literate materials, provided by the American Heart Association. The educational materials will promote management of risk factors and the notebook will provide an avenue for recording of lifestyle behaviors, such as health goals, BP values, and eating habits.
•Participants enrolled in the run-in phase will complete the following assessments at three time points (baseline, 6-months, and 12-months):
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resident of Grenada
- •One or more vascular risk factors:
- •Borderline to elevated blood pressure (defined as systolic blood pressure ≥120 mm Hg to SBP < 160 or diastolic blood pressure ≥ 80 and < 90 mm Hg)
- •Waist circumference of >40 inches for men and >35 inches for women
- •Smoking (active self-reported smoking, of any type of tobacco, at least daily)
- •Physical inactivity (reporting less than 120 min/week of activity)
- •Fasting glucose level > 100 mg/dl
- •Total Cholesterol >250 mg/dl, LDL > 130 mg/dl
- •Fruit/vegetable intake less than 2 servings daily
排除标准
- •Unable/unwilling to provide consent
- •Age of under 18 or more than 70 years old (inclusive) as of December 2012
- •Inability of self-monitoring
- •Pregnant women
- •Morbidly ill with expectation of death within a year
结局指标
主要结局
Composite GHP outcomes health score
时间窗: 12 months
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
次要结局
- Change in behavior(baseline and 12 months)
- Change in blood pressure(baseline and 12 months)
- Change in body weight(baseline and 12 months)
研究者
Valentin Fuster
Director, Mount Sinai Heart
Icahn School of Medicine at Mount Sinai