The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (AWESOME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00827424|
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : August 24, 2010
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.
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.
Implementing a modified PACE protocol can achieve this objectives in Arab women.
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Lifestyle counseling by applying a modified PACE protocol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||July 2010|
This arm will receive Lifestyle counseling by applying a modified PACE protocol
Behavioral: Lifestyle counseling by applying a modified PACE protocol
Lifestyle counseling by applying a modified PACE protocol to obese Arab women
No Intervention: 2
Subject in this arm will be recruited but will receive no intervention
- A significant change in BMI [ Time Frame: every 3 months for 18 month ]
- Patient's lifestyle habits: physical activity, eating habits [ Time Frame: every 3 months for 18 month ]
- Patient's clinical measures: BP, Waist Circumference [ Time Frame: every 3 months for 18 month ]
- Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG) [ Time Frame: every 3 months for 18 month ]
- Patient's readiness for change: Determined by the PACE score [ Time Frame: every 3 months for 18 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827424
|Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .|
|Haifa,, Israel, 35024|
|Principal Investigator:||Batya Kornboim, MD||Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .|
|Principal Investigator:||Uzi Milman, MD||Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .|