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| Name | Class |
|---|---|
| Fundación Santos y de la Garza Evia I.B.P | UNKNOWN |
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This is an open, randomized, controlled trial to determine the impact of an integrative group program on metabolic control and wellbeing perception of patients with T2DM. The integrative group program consists of 6 in-person sessions directed by a health coach and occurring every other week, and 6 asynchronous educative sessions during a period of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Conventional treatment for T2DM + Integrative Group Program |
|
| Control Group | Active Comparator | Conventional treatment for T2DM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrative Group Program | Other | The integrative group program consists of 6 in-person sessions directed by a health coach and occurring every other week, and 6 asynchronous educative sessions during a period of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c levels (%) | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c levels (%) | Baseline to 12 weeks and 36 weeks | |
| Fasting insulin (mU/mL) | Baseline to 12 weeks and 36 weeks | |
| Fasting glucose (mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regina Moreno, MD | Contact | +52 33 367 668 77 | regina.moreno@tecsalud.mx |
| Name | Affiliation | Role |
|---|---|---|
| Tania Zertuche, MD | Director de Instituto de Bienestar y Prevención | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Zambrano Hellion, Fundación Santos y de la Garza Evia I.B.P, TecSalud | Recruiting | San Pedro Garza García | Nuevo León | 66278 | Mexico |
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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 treatment for T2DM | Other | Conventional medical treatment for T2DM |
|
| Baseline to 12 weeks and 36 weeks |
| Homeostatic Model Assessment (HOMA index) | Baseline to 12 weeks and 36 weeks |
| High-sensitivity C-reactive protein (hs-CRP, mg/dL) | Baseline to 12 weeks and 36 weeks |
| Change in lifestyle instrument | Instrument to measure diabetic lifestyles (IMEVID) total score | Baseline to 12 weeks and 36 weeks |
| Subjective sense of wellbeing instrument | Positive emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA-profiler) score | Baseline to 12 weeks and 36 weeks |
| Adherence to pharmacological interventions for T2DM | Adherence to Refill and Medication Scale (ARMS) score | Baseline to 12 weeks and 36 weeks |
| Change in dose of pharmacological interventions for T2DM | Baseline to 12 weeks and 36 weeks |
| Centro de Salud Integral, Fundación Santos y de la Garza Evia I.B.P, TecSalud | Recruiting | Santa Catarina | Nuevo León | 66369 | Mexico |
|
| D004700 | Endocrine System Diseases |