The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Lifestyle counseling by applying a modified PACE protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This arm will receive Lifestyle counseling by applying a modified PACE protocol | Behavioral: Lifestyle counseling by applying a modified PACE protocol<br>* Lifestyle counseling by applying a modified PACE protocol to obese Arab women<br>|
| No Intervention: 2<br>Subject in this arm will be recruited but will receive no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A significant change in BMI |  | every 3 months for 18 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's lifestyle habits: physical activity, eating habits |  | every 3 months for 18 month | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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