Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273572
Status:
COMPLETED
Last Update Posted:
2008-10-29
First Post:
2006-01-05
Brief Title:
Lifestyle Intervention in Obese Arab Women
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese non-diabetic Arab women
Detailed Description:
200 obese non-diabetic Arab women 35-54 years old with one or more parameters of the metabolic syndrome NCEP-III criteria will be randomized to either conventional or intensive treatment The intensive intervention arm will include group meetings with physical education instructor twice a monthgroup meetings with a dietician once per month and personal dietary counselling once per month The targets to be achieved will be at least 7 reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 minweekEvaluation before enrollment and at the end of the trial will include information on dietary and physical activity habits quality of life parameters anthropometric and blood pressure measurement blood lipid profile and fasting and post oral glucose load blood glucose and insulin levels Duration of the intervention 12 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None