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The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.
Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Usual Care that the Type 2 Diabetes Patients usually receive at the health centers. | |
| 2 | Experimental | Cognitive Behavioral Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Intervention | Behavioral | The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is improvement in metabolic control (HbA1c). | The primary outcome was evaluated at 4- and 12-months following randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the intervention | 4- and 12-months following the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milagros C Rosal, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northgate Medical Center | Springfield | Massachusetts | 01103 | United States | ||
| Brightwood Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25547339 | Derived | Wang ML, Gellar L, Nathanson BH, Pbert L, Ma Y, Ockene I, Rosal MC. Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes. J Acad Nutr Diet. 2015 Jun;115(6):898-906. doi: 10.1016/j.jand.2014.10.012. Epub 2014 Dec 26. | |
| 20003208 | Derived | Rosal MC, White MJ, Restrepo A, Olendzki B, Scavron J, Sinagra E, Ockene IS, Thompson M, Lemon SC, Candib LM, Reed G. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-income Latinos: Latinos en Control. BMC Med Res Methodol. 2009 Dec 9;9:81. doi: 10.1186/1471-2288-9-81. |
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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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|
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| Springfield |
| Massachusetts |
| 01107 |
| United States |
| High Street Health Center | Springfield | Massachusetts | 01199 | United States |
| Plumley Village | Worcester | Massachusetts | 01608 | United States |
| Family Health Center | Worcester | Massachusetts | 01610 | United States |
| D004700 | Endocrine System Diseases |