Lifestyle Intervention in Obese Arab Women
October 27, 2008 updated by: Sheba Medical Center
The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 month),group 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 min/week.Evaluation 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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tel-Hashomer, Ramat-Gan, Israel, 52621
- Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 54 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Obesity (BMI: 30-40 kg/squared meter)
- Female Gender
- Being 35-54 years old
Exclusion Criteria:
- Diabetic
A contraindication for physical activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Moderate lifestyle intervention
Moderate lifestyle intervention including two group sessions and one individual counselling session with a nutritionist, at recruitment.
Individual sessions with a nutritionist after 6 and 12 months on follow-up.
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Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
Other Names:
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Experimental: Intensive lifestyle intervention
Intensive lifestyle intervention, including bi-monthly group sessions with a physical activity instructor; a monthly group session with a nutritionist, and a monthly individual session with a nutritionist.
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A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parameters of the metabolic syndrome
Time Frame: At baseline, and after 6 and 12 months
|
At baseline, and after 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: At baseline, and after 12 months
|
At baseline, and after 12 months
|
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Attainment of weight reduction and physical activity targets
Time Frame: At baseline, and after 6 and 12 months
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At baseline, and after 6 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ofra Kalter - Leibovici, M.D., Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
January 5, 2006
First Submitted That Met QC Criteria
January 5, 2006
First Posted (Estimate)
January 9, 2006
Study Record Updates
Last Update Posted (Estimate)
October 29, 2008
Last Update Submitted That Met QC Criteria
October 27, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-04-3335-OK-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.