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

NCT00827424 | Completed

• 1 other identifier: CMC-07-0054CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• A significant change in BMI

  every 3 months for 18 month

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Lifestyle counseling by applying a modified PACE protocol

2

NO INTERVENTION

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

Interventions

Lifestyle counseling by applying a modified PACE protocol BEHAVIORAL

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

1

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Arab women
• Age range 35-64
• Insured by Clalit Health Services (CHS)
• Residence in the target communities
• BMI \> 30 kg/m2
• Signed informed consent

Sponsors & Collaborators

• Clalit Health Services: lead

Study Sites (1)

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

Haifa, 35024, Israel

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• 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 .

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 24, 2010

Record last verified: 2010-08

Locations

IL (1)