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

This study has been completed.
Sponsor:
Information provided by:
Clalit Health Services
ClinicalTrials.gov Identifier:
NCT00827424
First received: January 21, 2009
Last updated: August 23, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Lifestyle counseling by applying a modified PACE protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • A significant change in BMI [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's lifestyle habits: physical activity, eating habits [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
  • Patient's clinical measures: BP, Waist Circumference [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
  • Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG) [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]
  • Patient's readiness for change: Determined by the PACE score [ Time Frame: every 3 months for 18 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827424

Locations
Israel
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Haifa,, Israel, 35024
Sponsors and Collaborators
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 .
  More Information

No publications provided

Responsible Party: Batya Kornboim MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District
ClinicalTrials.gov Identifier: NCT00827424     History of Changes
Other Study ID Numbers: CMC-07-0054CTIL
Study First Received: January 21, 2009
Last Updated: August 23, 2010
Health Authority: Israel: Clalit Health services

Keywords provided by Clalit Health Services:
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cisplatin
Cyclophosphamide
Doxorubicin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014