Clinical trial NCT00827424: The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: 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
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: A significant change in BMI
timeFrame: every 3 months for 18 month
Secondary outcomes:
measure: Patient's lifestyle habits: physical activity, eating habits
timeFrame: every 3 months for 18 month
measure: Patient's clinical measures: BP, Waist Circumference
timeFrame: every 3 months for 18 month
measure: Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
timeFrame: every 3 months for 18 month
measure: Patient's readiness for change: Determined by the PACE score
timeFrame: every 3 months for 18 month
Other outcomes:
Locations:
city: Haifa,
country: Israel
facility: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Study officials:
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
name: Batya Kornboim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
name: Uzi Milman, MD
role: PRINCIPAL_INVESTIGATOR
References: