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The study will compare two different programs for lifestyle intervention in type 2 diabetes:
The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief lifestyle program | Experimental | 3-session lifestyle group intervention program focussed on physical activity and eating habits, using interactive methods and a behavioral approach |
|
| Traditional lifestyle longer program | Active Comparator | 6-session lifestyle group intervention program focussed on physical activity and eating habits, using traditional lessons and interactive methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief lifestyle program | Behavioral | 3-session program for modification of lifestyle habits (exercise and diet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at 6 months | 6 months | |
| Treatment success at 6 months | HbA1c within predefined target without any increase in pharmacological therapy | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success at 24 months | HbA1c within predefined target without any increase in pharmacological therapy | 24 months |
| HbA1c at 24 months | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mattreo Monami, MD | Contact | 3384027484 | matteo.monami@unifi.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetologia AOU Careggi | Recruiting | Florence | 50134 | Italy |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Conventional lifestyle program | Behavioral | 6-session program for modification of lifestyle habits (exercise and diet) |
|
| MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores | 14-item questionnaire with scores ranging from 0 (low adherence) to 18 (high adherence) | 24 months |
| International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores | 7-item questionnaire with scores ranging from 0 (no activity) to 7 (high activity) | 24 months |
| Well-being Enquiry in Diabetics (WED) questionnaire total score | 50-item questionnaire measuring diabetes-specific health-related quality of life, with scores ranging from 0 (low) to 50 (high). Only total score will be used in analysis 1. Mannucci E, et al., Diabetes Nutr Metab 9: 89-102, 1996). | 24 months |
| Body Mass Index | 6 months |
| Waist circumference | 6 months |
| Body Mass Index | 24 months |
| Waist circumference | 24 months |
| D004700 | Endocrine System Diseases |