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

Clalit Health Services

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Lifestyle counseling by applying a modified PACE protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00827424

CMC-07-0054CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 35 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

This arm will receive Lifestyle counseling by applying a modified PACE protocol

Treatment:

Behavioral: Lifestyle counseling by applying a modified PACE protocol

2

No Intervention group

Description:

Subject in this arm will be recruited but will receive no intervention