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NCT Number: NCT04971889

Diabetes Medical Nutrition Therapy in Southeastern African American Women

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Matthew Walker Comprehensive Health Center, Nashville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Motivational Interviewing

Behavioral

Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise

Primary outcomes

  1. HbA1c

    Time frame: Baseline

    Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.

  2. Change from Baseline HbA1c

    Time frame: 3 months

    Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.

  3. Change from Baseline HbA1c

    Time frame: 6 months

    Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.

  4. Change from Baseline HbA1c

    Time frame: 12 months

    Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.

Secondary outcomes

  1. Body Mass Index

    Time frame: Baseline

    Calculated measure of body max index from height/weight measures

  2. Change from Baseline Body Mass Index

    Time frame: 3 months

    Calculated measure of body max index from height/weight measures

  3. Change from Baseline Body Mass Index

    Time frame: 6 months

    Calculated measure of body max index from height/weight measures

  4. Change from Baseline Body Mass Index

    Time frame: 12 months

    Calculated measure of body max index from height/weight measures

  5. LDL Cholesterol

    Time frame: 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.

  6. Change from baseline LDL Cholesterol

    Time frame: 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.

  7. Change from baseline LDL Cholesterol

    Time frame: 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.

  8. Change from baseline LDL Cholesterol

    Time frame: 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.

  9. Systolic Blood Pressure

    Time frame: Baseline

    A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.

  10. Change from baseline Systolic Blood Pressure

    Time frame: 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.

  11. Change from baseline Systolic Blood Pressure

    Time frame: 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.

  12. Change from baseline Systolic Blood Pressure

    Time frame: 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 outcomes

  1. Carbohydrate Management Attitude Scale

    Time frame: Baseline

    Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.

  2. Change from baseline Carbohydrate Management Attitude Scale

    Time frame: 3 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.

  3. Change from baseline Carbohydrate Management Attitude Scale

    Time frame: 6 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.

  4. Change from baseline Carbohydrate Management Attitude Scale

    Time frame: 12 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.

  5. Fat Management Attitude Scale

    Time frame: Baseline

    Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.

  6. Change from baseline Fat Management Attitude Scale

    Time frame: 3 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.

  7. Change from baseline Fat Management Attitude Scale

    Time frame: 6 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.

  8. Change from baseline Fat Management Attitude Scale

    Time frame: 12 months

    Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.

  9. Diabetes Empowerment Scale

    Time frame: Baseline

    Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.

  10. Change from baseline Diabetes Empowerment Scale

    Time frame: 3 months

    Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.

  11. Change from baseline Diabetes Empowerment Scale

    Time frame: 6 months

    Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.

  12. Change from baseline Diabetes Empowerment Scale

    Time frame: 12 months

    Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.

  13. Problem Areas in Diabetes Scale Questionnaire

    Time frame: Baseline

    Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.

  14. Change from baseline Problem Areas in Diabetes Scale Questionnaire

    Time frame: 3 months

    Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.

  15. Change from baseline Problem Areas in Diabetes Scale Questionnaire

    Time frame: 6 months

    Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.

  16. Change from baseline Problem Areas in Diabetes Scale Questionnaire

    Time frame: 12 months

    Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.

  17. Situational Obstacles to Dietary Adherence Questionnaire

    Time frame: 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.

  18. Change from baseline Situational Obstacles to Dietary Adherence Questionnaire

    Time frame: 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.

  19. Change from baseline Situational Obstacles to Dietary Adherence Questionnaire

    Time frame: 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.

  20. Change from baseline Situational Obstacles to Dietary Adherence Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Meharry Medical College

Other

Collaborators

  • Matthew Walker Comprehensive Health Center
  • Patient-Centered Outcomes Research Institute
  • Vanderbilt University

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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