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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Haifa,, Israel, 35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Ingen indgriben: 2
Subject in this arm will be recruited but will receive no intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
A significant change in BMI
Tidsramme: every 3 months for 18 month
|
every 3 months for 18 month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patient's lifestyle habits: physical activity, eating habits
Tidsramme: every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's clinical measures: BP, Waist Circumference
Tidsramme: every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Tidsramme: every 3 months for 18 month
|
every 3 months for 18 month
|
|
Patient's readiness for change: Determined by the PACE score
Tidsramme: every 3 months for 18 month
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every 3 months for 18 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Batya Kornboim, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- Ledende efterforsker: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMC-07-0054CTIL
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