- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Haifa,, Israel, 35024
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Inget ingripande: 2
Subject in this arm will be recruited but will receive no intervention
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
A significant change in BMI
Tidsram: every 3 months for 18 month
|
every 3 months for 18 month
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Patient's lifestyle habits: physical activity, eating habits
Tidsram: every 3 months for 18 month
|
every 3 months for 18 month
|
Patient's clinical measures: BP, Waist Circumference
Tidsram: every 3 months for 18 month
|
every 3 months for 18 month
|
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Tidsram: every 3 months for 18 month
|
every 3 months for 18 month
|
Patient's readiness for change: Determined by the PACE score
Tidsram: every 3 months for 18 month
|
every 3 months for 18 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Batya Kornboim, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
- Huvudutredare: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CMC-07-0054CTIL
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Kliniska prövningar på Fetma
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SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark