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| Name | Class |
|---|---|
| D-Cure, Israel | INDUSTRY |
| Chief Scientist, The Israel Ministry of Science | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate lifestyle intervention | Active Comparator | 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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| Intensive lifestyle intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Lifestyle Intervention | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of the metabolic syndrome | At baseline, and after 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | At baseline, and after 12 months | |
| Attainment of weight reduction and physical activity targets | At baseline, and after 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
A contraindication for physical activity
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| Name | Affiliation | Role |
|---|---|---|
| Ofra Kalter - Leibovici, M.D. | Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center | Tel-Hashomer, Ramat-Gan | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20548010 | Derived | Kalter-Leibovici O, Younis-Zeidan N, Atamna A, Lubin F, Alpert G, Chetrit A, Novikov I, Daoud N, Freedman LS. Lifestyle intervention in obese Arab women: a randomized controlled trial. Arch Intern Med. 2010 Jun 14;170(11):970-6. doi: 10.1001/archinternmed.2010.103. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Intensive lifestyle intervention | Other | A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |