The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (AWESOME)
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)
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Haifa,, 이스라엘, 35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
This arm will receive Lifestyle counseling by applying a modified PACE protocol
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Lifestyle counseling by applying a modified PACE protocol to obese Arab women
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간섭 없음: 2
Subject in this arm will be recruited but will receive no intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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A significant change in BMI
기간: every 3 months for 18 month
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every 3 months for 18 month
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Patient's lifestyle habits: physical activity, eating habits
기간: every 3 months for 18 month
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every 3 months for 18 month
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Patient's clinical measures: BP, Waist Circumference
기간: every 3 months for 18 month
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every 3 months for 18 month
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Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
기간: every 3 months for 18 month
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every 3 months for 18 month
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Patient's readiness for change: Determined by the PACE score
기간: every 3 months for 18 month
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every 3 months for 18 month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Batya Kornboim, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- 수석 연구원: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CMC-07-0054CTIL
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