The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (AWESOME)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Lifestyle counseling by applying a modified PACE protocol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- A significant change in BMI [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
- Patient's lifestyle habits: physical activity, eating habits [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
- Patient's clinical measures: BP, Waist Circumference [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
- Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG) [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
- Patient's readiness for change: Determined by the PACE score [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Eligibility| Ages Eligible for Study: | 35 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Israel | |
| 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 . |
More Information
No publications provided
| Responsible Party: | Batya Kornboim MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District |
| ClinicalTrials.gov Identifier: | NCT00827424 History of Changes |
| Other Study ID Numbers: | CMC-07-0054CTIL |
| Study First Received: | January 21, 2009 |
| Last Updated: | August 23, 2010 |
| Health Authority: | Israel: Clalit Health services |
Keywords provided by Clalit Health Services:
|
physical activity (PA) obesity life style modification physical activity diet |
BMI reduction clinical and metabolic measure health expenditure improvement of patient readiness for lifestyle change |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Cisplatin Cyclophosphamide Doxorubicin Etoposide Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antibiotics, Antineoplastic Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013