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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Haifa,、イスラエル、35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし:2
Subject in this arm will be recruited but will receive no intervention
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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A significant change in BMI
時間枠:every 3 months for 18 month
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every 3 months for 18 month
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Patient's lifestyle habits: physical activity, eating habits
時間枠: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
時間枠: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)
時間枠: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
時間枠:every 3 months for 18 month
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every 3 months for 18 month
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Batya Kornboim, MD、Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- 主任研究者:Uzi Milman, MD、Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CMC-07-0054CTIL
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。