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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Haifa,, Israel, 35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Kein Eingriff: 2
Subject in this arm will be recruited but will receive no intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
A significant change in BMI
Zeitfenster: every 3 months for 18 month
|
every 3 months for 18 month
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Patient's lifestyle habits: physical activity, eating habits
Zeitfenster: every 3 months for 18 month
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every 3 months for 18 month
|
|
Patient's clinical measures: BP, Waist Circumference
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: every 3 months for 18 month
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every 3 months for 18 month
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Batya Kornboim, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- Hauptermittler: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CMC-07-0054CTIL
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