- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00827424
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Haifa,, Israel, 35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
This arm will receive Lifestyle counseling by applying a modified PACE protocol
|
Lifestyle counseling by applying a modified PACE protocol to obese Arab women
|
|
Ingen inngripen: 2
Subject in this arm will be recruited but will receive no intervention
|
Hva måler studien?
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
|
every 3 months for 18 month
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Batya Kornboim, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- Hovedetterforsker: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMC-07-0054CTIL
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