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Completed

NCT Number: NCT00827424

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

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.

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Key information

Age range

35 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Haifa, 35024, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle counseling by applying a modified PACE protocol

Behavioral

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

Primary outcomes

  1. A significant change in BMI

    Time frame: every 3 months for 18 month

Secondary outcomes

  1. Patient's lifestyle habits: physical activity, eating habits

    Time frame: every 3 months for 18 month

  2. Patient's clinical measures: BP, Waist Circumference

    Time frame: every 3 months for 18 month

  3. Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)

    Time frame: every 3 months for 18 month

  4. Patient's readiness for change: Determined by the PACE score

    Time frame: every 3 months for 18 month

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Registry information

Official study 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)

Acronym: AWESOME

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2009
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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