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

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)

Patrocinadores

Patrocinador principal: Clalit Health Services

Fuente Clalit Health Services
Resumen breve

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.

Estado general Completed
Fecha de inicio December 2008
Fecha de Terminación July 2010
Fecha de finalización primaria May 2010
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
A significant change in BMI every 3 months for 18 month
Resultado secundario
Medida Periodo de tiempo
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
Inscripción 100
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Lifestyle counseling by applying a modified PACE protocol

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

Etiqueta de grupo de brazo: 1

Elegibilidad

Criterios:

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

Género: Female

Edad mínima: 35 Years

Edad máxima: 64 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Ubicación
Instalaciones: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Ubicacion Paises

Israel

Fecha de verificación

August 2010

Fiesta responsable

Nombre Titulo: Batya Kornboim MD

Organización: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: 1

Tipo: Experimental

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

Etiqueta: 2

Tipo: No Intervention

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

Acrónimo AWESOME
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov