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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Matthew Walker Comprehensive Health Center | UNKNOWN |
| Vanderbilt University | OTHER |
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A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes MNT plus MI | Active Comparator | --Group-based dietary/dietary motivation intervention |
|
| Diabetes MNT | Active Comparator | -Group-based dietary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes MNT | Behavioral | Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples. | Baseline |
| Change from Baseline HbA1c | Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples. | 3 months |
| Change from Baseline HbA1c | Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples. | 6 months |
| Change from Baseline HbA1c | Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Calculated measure of body max index from height/weight measures | Baseline |
| Change from Baseline Body Mass Index | Calculated measure of body max index from height/weight measures |
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrate Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management. | Baseline |
| Change from baseline Carbohydrate Management Attitude Scale |
Inclusion Criteria:
Exclusion Criteria:
--Observed or diagnosed psychotic disorders
Self-identification
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matthew Walker Comprehensive Health Center | Nashville | Tennessee | 37208 | United States | ||
| Meharry Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36526256 | Background | Miller ST, Akohoue SA, Murry VM, Tabatabai M, Wilus D, Foxx A. SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women. Contemp Clin Trials. 2023 Feb;125:107052. doi: 10.1016/j.cct.2022.107052. Epub 2022 Dec 13. |
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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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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Motivational Interviewing | Behavioral | Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise |
|
| 3 months |
| Change from Baseline Body Mass Index | Calculated measure of body max index from height/weight measures | 6 months |
| Change from Baseline Body Mass Index | Calculated measure of body max index from height/weight measures | 12 months |
| LDL Cholesterol | Standard enzymatic laboratory procedures will be used to assess total cholesterol, HDL cholesterol, and triglycerides from whole blood. LDL will be calculated based on total cholesterol and HDL values. | Baseline |
| Change from baseline LDL Cholesterol | Standard enzymatic laboratory procedures will be used to assess total cholesterol, HDL cholesterol, and triglycerides from whole blood. LDL will be calculated based on total cholesterol and HDL values. | 3 months |
| Change from baseline LDL Cholesterol | Standard enzymatic laboratory procedures will be used to assess total cholesterol, HDL cholesterol, and triglycerides from whole blood. LDL will be calculated based on total cholesterol and HDL values. | 6 months |
| Change from baseline LDL Cholesterol | Standard enzymatic laboratory procedures will be used to assess total cholesterol, HDL cholesterol, and triglycerides from whole blood. LDL will be calculated based on total cholesterol and HDL values. | 12 months |
| Systolic Blood Pressure | A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated. | Baseline |
| Change from baseline Systolic Blood Pressure | A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated. | 3 months |
| Change from baseline Systolic Blood Pressure | A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated. | 6 months |
| Change from baseline Systolic Blood Pressure | A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated. | 12 months |
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
| 3 months |
| Change from baseline Carbohydrate Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management. | 6 months |
| Change from baseline Carbohydrate Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management. | 12 months |
| Fat Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management. | Baseline |
| Change from baseline Fat Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management. | 3 months |
| Change from baseline Fat Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management. | 6 months |
| Change from baseline Fat Management Attitude Scale | Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management. | 12 months |
| Diabetes Empowerment Scale | Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care. | Baseline |
| Change from baseline Diabetes Empowerment Scale | Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care. | 3 months |
| Change from baseline Diabetes Empowerment Scale | Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care. | 6 months |
| Change from baseline Diabetes Empowerment Scale | Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care. | 12 months |
| Problem Areas in Diabetes Scale Questionnaire | Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills. | Baseline |
| Change from baseline Problem Areas in Diabetes Scale Questionnaire | Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills. | 3 months |
| Change from baseline Problem Areas in Diabetes Scale Questionnaire | Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills. | 6 months |
| Change from baseline Problem Areas in Diabetes Scale Questionnaire | Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills. | 12 months |
| Situational Obstacles to Dietary Adherence Questionnaire | Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options. | Baseline |
| Change from baseline Situational Obstacles to Dietary Adherence Questionnaire | Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options. | 3 months |
| Change from baseline Situational Obstacles to Dietary Adherence Questionnaire | Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options. | 6 months |
| Change from baseline Situational Obstacles to Dietary Adherence Questionnaire | Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options. | 12 months |
| Nashville |
| Tennessee |
| 37208 |
| United States |
| D004700 | Endocrine System Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |