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

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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Lifestyle counseling by applying a modified PACE protocol

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa,, Israel, 35024
    • Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Clalit Health Services
• Investigators: 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 .

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: physical activity; obesity; diet; BMI reduction; physical activity (PA); life style modification; clinical and metabolic measure; health expenditure; improvement of patient readiness for lifestyle change
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CMC-07-0054CTIL