Diabetes Medical Nutrition Therapy in Southeastern African American Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Diabetes MNT plus MI --Group-based dietary/dietary motivation intervention |
Behavioral: Diabetes MNT
Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake
Behavioral: Motivational Interviewing
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
|
| Active Comparator: Diabetes MNT -Group-based dietary intervention |
Behavioral: Diabetes MNT
Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake
|
Outcome Measures
Primary Outcome Measures
- HbA1c [Baseline]
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
- Change from Baseline HbA1c [3 months]
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
- Change from Baseline HbA1c [6 months]
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
- Change from Baseline HbA1c [12 months]
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Secondary Outcome Measures
- Body Mass Index [Baseline]
Calculated measure of body max index from height/weight measures
- Change from Baseline Body Mass Index [3 months]
Calculated measure of body max index from height/weight measures
- Change from Baseline Body Mass Index [6 months]
Calculated measure of body max index from height/weight measures
- Change from Baseline Body Mass Index [12 months]
Calculated measure of body max index from height/weight measures
- LDL Cholesterol [Baseline]
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.
- Change from baseline LDL Cholesterol [3 months]
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.
- Change from baseline LDL Cholesterol [6 months]
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.
- Change from baseline LDL Cholesterol [12 months]
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.
- Systolic Blood Pressure [Baseline]
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
- Change from baseline Systolic Blood Pressure [3 months]
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
- Change from baseline Systolic Blood Pressure [6 months]
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
- Change from baseline Systolic Blood Pressure [12 months]
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Other Outcome Measures
- Carbohydrate Management Attitude Scale [Baseline]
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
- Change from baseline Carbohydrate Management Attitude Scale [3 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
- Change from baseline Carbohydrate Management Attitude Scale [6 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
- Change from baseline Carbohydrate Management Attitude Scale [12 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
- Fat Management Attitude Scale [Baseline]
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
- Change from baseline Fat Management Attitude Scale [3 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
- Change from baseline Fat Management Attitude Scale [6 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
- Change from baseline Fat Management Attitude Scale [12 months]
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
- Diabetes Empowerment Scale [Baseline]
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
- Change from baseline Diabetes Empowerment Scale [3 months]
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
- Change from baseline Diabetes Empowerment Scale [6 months]
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
- Change from baseline Diabetes Empowerment Scale [12 months]
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
- Problem Areas in Diabetes Scale Questionnaire [Baseline]
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
- Change from baseline Problem Areas in Diabetes Scale Questionnaire [3 months]
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
- Change from baseline Problem Areas in Diabetes Scale Questionnaire [6 months]
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
- Change from baseline Problem Areas in Diabetes Scale Questionnaire [12 months]
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
- Situational Obstacles to Dietary Adherence Questionnaire [Baseline]
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.
- Change from baseline Situational Obstacles to Dietary Adherence Questionnaire [3 months]
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.
- Change from baseline Situational Obstacles to Dietary Adherence Questionnaire [6 months]
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.
- Change from baseline Situational Obstacles to Dietary Adherence Questionnaire [12 months]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Matthew Walker Comprehensive Health Center | Nashville | Tennessee | United States | 37208 |
| 2 | Meharry Medical College | Nashville | Tennessee | United States | 37208 |
Sponsors and Collaborators
- Meharry Medical College
- Patient-Centered Outcomes Research Institute
- Matthew Walker Comprehensive Health Center
- Vanderbilt University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-02-1069