跳至主要内容
临床试验/NCT00827424
NCT00827424已完成不适用

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)

Clalit Health Services2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
A significant change in BMI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Arab women
  • Age range 35-64
  • Insured by Clalit Health Services (CHS)
  • Residence in the target communities
  • BMI > 30 kg/m2
  • Signed informed consent

排除标准

  • Failure in any of the inclusion criteria

结局指标

主要结局

A significant change in BMI

时间窗: every 3 months for 18 month

次要结局

  • Patient's clinical measures: BP, Waist Circumference(every 3 months for 18 month)
  • Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)(every 3 months for 18 month)
  • Patient's readiness for change: Determined by the PACE score(every 3 months for 18 month)
  • Patient's lifestyle habits: physical activity, eating habits(every 3 months for 18 month)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验

The Impact of the PACE Program Implementation on... | 临床试验