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To evaluate the effectiveness of the Farsi diabetes self-management education program on psychosocial, lifestyle, and clinical measures in people with newly diagnosed people with type 2 diabetes and those with already-diagnosed type two diabetes who had received little self-management education. The development of the program was guided by an innovative process of intervention planning: Intervention Mapping.
For designing the management program, we will use Intervention Mapping (IM) framework for systematically developing the theory and evidence based program.
Based on IM approach, this study will have seven phases:
Step 1: needs assessment (Development the problem analysis: health, quality of life, behavior, environment).
Step 2: We will develop proximal program objectives with a multidisciplinary expert panel of participants.
Step 3: After identification of the proximal program objectives, the next step will be to select theoretical methods and practical strategies based on evidence for alternative methods.
Step 4: The forth step of the program development will comprise of composing program materials and pre-testing these materials with a sample of patients at a diabetic outpatient clinic.
Step 5: By involving the future program facilitators (health care workers at outpatient clinics) a linkage system will be foreseen.
Step 6: planning for evaluation Step 7: Randomized Clinical Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDSME group | Experimental | In the FDSME group, sessions will be held interactive; and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. |
|
| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDSME group | Behavioral | In the intervention group, diabetes education sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | within 2 years | |
| BMI | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Audit of Diabetes-Dependent Quality of Life (ADDQOL) | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| FDSME | Behavioral | In the intervention group, sessions which are designed based on the "Intervention Mapping" will be interactive and reflection in between sessions will be encouraged. Group-based problem-solving exercises will be used during the sessions. Participants receive feedback from peers and healthcare professionals at the following sessions. |
|