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

Obesity Clinical Trial

— AWESOME  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827424
• Other study ID #: CMC-07-0054CTIL
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: August 23, 2010
• Start date: December 2008
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Lifestyle counseling by applying a modified PACE protocol
Lifestyle counseling by applying a modified PACE protocol to obese Arab women

Locations

Country	Name	City	State
Israel	Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .	Haifa,

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A significant change in BMI		every 3 months for 18 month	No
Secondary	Patient's lifestyle habits: physical activity, eating habits		every 3 months for 18 month	No
Secondary	Patient's clinical measures: BP, Waist Circumference		every 3 months for 18 month	No
Secondary	Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)		every 3 months for 18 month	No
Secondary	Patient's readiness for change: Determined by the PACE score		every 3 months for 18 month	No