Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALDiabetes 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
BEHAVIORALMotivational Interviewing
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
Sponsors
Patient-Centered Outcomes Research Institute
Matthew Walker Comprehensive Health Center
Vanderbilt University
Meharry Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Body Mass Index | 3 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. |
| 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 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. |
| Body Mass Index | Baseline | Calculated measure of body max index from height/weight measures |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Carbohydrate Management Attitude Scale | Baseline | Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management. |
| 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 Carbohydrate Management Attitude Scale | 3 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed