Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors (GHP CHANGE)
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.
研究概览
详细说明
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):
- Anthropometric measurements
- GHP data collection form
- International physical activity questionnaire (iPAQ)
- Lifestyle Assessment [modified SF-36 questionnaire tailored to the Grenadian population]
- Point-of-care testing using an LDX analyzer (solely for the 12 month assessment).
The investigators have developed a "GHP Health outcomes Score" which captures a person's health profile on a 0-to-3 point scale related to smoking habits, overweight, sedentary lifestyle, and hypertension During the run-in phase, participants will attend a series of core lifestyle and risk factor education workshops related to motivation for change, nutrition (two sessions), smoking cessation, physical education and BP control. Only those participants who attend 4 of the 6 sessions will be eligible for randomization.
Eligible participants will be randomized to the intervention arm or to the control arm, stratified by parish. In the group intervention arm a group leader will be selected internally within the support groups, who will receive additional training from the research team in regards to group motivation and facilitation. Those randomized into the Intervention arm will be organized into peer groups of approximately 10 persons.
The specific aims of this study are:
Specific Aim 1: Hypothesis: Individuals will show an improvement of health-related behaviors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 2: Hypothesis: Individuals will show an improvement in their quality of life through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 3: Hypothesis: Individuals will show an improvement in cardiovascular risk factors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
St. George's、格林纳达
- St. George's University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Peer Groups
Individuals in Intervention Group Arm will attend biweekly or monthly peer support groups (approximately 10 people per group) for evaluating changes and promoting mutual support.
12-month duration.
|
The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.
|
|
无干预：Control Arm
The control arm, will attend the initial educational group lectures at baseline assessment and will receive no intervention thereafter.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite GHP outcomes health score
大体时间：baseline
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
baseline
|
|
Composite GHP outcomes health score
大体时间：6 months
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
6 months
|
|
Composite GHP outcomes health score
大体时间：12 months
|
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in blood pressure
大体时间：baseline and 12 months
|
Change in blood pressure at 12 months as compared to baseline
|
baseline and 12 months
|
|
Change in body weight
大体时间：baseline and 12 months
|
Change in body weight at 12 months as compared to baseline
|
baseline and 12 months
|
|
Change in behavior
大体时间：baseline and 12 months
|
Change in behavior as 12 months as compared to baseline
|
baseline and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Valentin Fuster, MD、Icahn School of Medicine at Mount Sinai
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.