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The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavrioal Lifestyle modification | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behvarioal lifestyle modification | Behavioral | A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c% | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 6 months | |
| Body composition analysis | 6 months | |
| Lipid profile ( serum cholesterol, LDL, HDL, triglycerides) |
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Inclusion Criteria:
Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c > 7%.
Exclusion Criteria:
major physical activity disability that restricts participation in moderate physical activity.
serious heart condition like heart failure, heart attack, stroke within the last 3 months.
participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rashid Centre for Diabetes and Research | Ajman | United Arab Emirates |
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|
| 6 months |
| Blood presssure (systolic and diastolic) | 6 months |
| carbohydrates intake in grams | 6 months |
| physical exercise in minutes per day | 6 months |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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