The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (AWESOME)
The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (The AWESOME Study: Arab WomEn Study on Obesity Metabolism and Exercise)
Scientific background:
Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. The economic impact of obesity and overweight in terms of illness, disease and lost productivity is estimated to amount to 2-9% of the national health budget in countries with high GDP. Diabetics have medical expenditure that is 2.4 times higher than non diabetics per capita.
Lifestyle modification is an effective tool in reducing morbidity and health care expenditure but despite that most family practitioners usually treat the complications of obesity rather than preventing it.
PACE is a comprehensive health promotion guide in counseling patients to an active healthy lifestyle. PACE is designed to assist the primary health care providers to promote physical activity and dietary changes during routine office visits.
Objectives:
To asses the impact of PACE program on increasing the amount of physical activity, improving clinical and metabolic indices, increasing the documentation of lifestyle indices in the medical records and reducing health care expenditure and utilization.
Working hypothesis:
Implementing a modified PACE protocol can achieve this objectives in Arab women.
Methodology:
The investigators will conduct a structured, multidisciplinary and continuous primary care based intervention, assisted by trained health promoters and applying a locally adjusted PACE protocol.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Haifa,、以色列、35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
-
-
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:
- Arab women
- Age range 35-64
- Insured by Clalit Health Services (CHS)
- Residence in the target communities
- BMI > 30 kg/m2
- Signed informed consent
Exclusion Criteria:
- Failure in any of the inclusion criteria
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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:1
This arm will receive Lifestyle counseling by applying a modified PACE protocol
|
Lifestyle counseling by applying a modified PACE protocol to obese Arab women
|
|
无干预:2
Subject in this arm will be recruited but will receive no intervention
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
A significant change in BMI
大体时间:every 3 months for 18 month
|
every 3 months for 18 month
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Patient's lifestyle habits: physical activity, eating habits
大体时间:every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's clinical measures: BP, Waist Circumference
大体时间:every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
大体时间:every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's readiness for change: Determined by the PACE score
大体时间:every 3 months for 18 month
|
every 3 months for 18 month
|
合作者和调查者
调查人员
- 首席研究员:Batya Kornboim, MD、Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- 首席研究员:Uzi Milman, MD、Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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
与本研究相关的术语
关键字
其他研究编号
- CMC-07-0054CTIL
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.