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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle counseling by applying a modified PACE protocol

• Registration Number: NCT00827424
• Lead Sponsor: Clalit Health Services

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lifestyle counseling by applying a modified PACE protocol	This arm will receive Lifestyle counseling by applying a modified PACE protocol

Primary Outcome Measures

Name	Time	Method
A significant change in BMI	every 3 months for 18 month

Secondary Outcome Measures

Name	Time	Method
Patient's readiness for change: Determined by the PACE score	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 lifestyle habits: physical activity, eating habits	every 3 months for 18 month

Trial Locations

Locations (1)

Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .; 🇮🇱 Haifa,, Israel