Diabetes Medical Nutrition Therapy in Southeastern African American Women

Study Overview
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Brief Summary
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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.

Official Title
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Diabetes Medical Nutrition Therapy in Southeastern African American Women

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Diabetes MNT
* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American Female Clinical diagnosis of type 2 diabetes for at least 6 months At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0% AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30). Exclusion Criteria: --Observed or diagnosed psychotic disorders

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diabetes MNT plus MI<br>--Group-based dietary/dietary motivation intervention | Behavioral: Diabetes MNT<br>* Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake<br>Behavioral: Motivational Interviewing<br>* Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise<br>|
| Active Comparator: Diabetes MNT<br>-Group-based dietary intervention | Behavioral: Diabetes MNT<br>* Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |