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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lifestyle counseling by applying a modified PACE protocol
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring 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

Eligibility Criteria

35 Years - 64 Years (Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

A significant change in BMI

Secondary Outcome Measures

Patient's lifestyle habits: physical activity, eating habits
Patient's clinical measures: BP, Waist Circumference
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Patient's readiness for change: Determined by the PACE score

Full Information

First Posted
January 21, 2009
Last Updated
August 23, 2010
Sponsor
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00827424
Brief Title
The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women
Acronym
AWESOME
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

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Clalit Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
This arm will receive Lifestyle counseling by applying a modified PACE protocol
Arm Title
2
Arm Type
No Intervention
Arm Description
Subject in this arm will be recruited but will receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling by applying a modified PACE protocol
Intervention Description
Lifestyle counseling by applying a modified PACE protocol to obese Arab women
Primary Outcome Measure Information:
Title
A significant change in BMI
Time Frame
every 3 months for 18 month
Secondary Outcome Measure Information:
Title
Patient's lifestyle habits: physical activity, eating habits
Time Frame
every 3 months for 18 month
Title
Patient's clinical measures: BP, Waist Circumference
Time Frame
every 3 months for 18 month
Title
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Time Frame
every 3 months for 18 month
Title
Patient's readiness for change: Determined by the PACE score
Time Frame
every 3 months for 18 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Batya Kornboim, MD
Organizational Affiliation
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uzi Milman, MD
Organizational Affiliation
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
City
Haifa,
ZIP/Postal Code
35024
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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