Diabetes Medical Nutrition Therapy in Southeastern African American Women

December 9, 2025 updated by: Stephania T. Miller-Hughes, Meharry Medical College
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
291

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Stephania Miller-Hughes, PhD
  • Phone Number: 16153275666
  • Email: smiller@mmc.edu

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37208
        • Matthew Walker Comprehensive Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Baseline
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 months
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.
6 months
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Baseline
Calculated measure of body max index from height/weight measures
Baseline
Change from Baseline Body Mass Index
Time Frame: 3 months
Calculated measure of body max index from height/weight measures
3 months
Change from Baseline Body Mass Index
Time Frame: 6 months
Calculated measure of body max index from height/weight measures
6 months
Change from Baseline Body Mass Index
Time Frame: 12 months
Calculated measure of body max index from height/weight measures
12 months
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.
Baseline
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.
3 months
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.
6 months
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.
12 months
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.
Baseline
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.
3 months
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.
6 months
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.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Carbohydrate Management Attitude Scale
Time Frame: Baseline
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
Baseline
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 months
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.
6 months
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.
12 months
Fat Management Attitude Scale
Time Frame: Baseline
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
Baseline
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.
3 months
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.
6 months
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.
12 months
Diabetes Empowerment Scale
Time Frame: Baseline
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
Baseline
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.
3 months
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.
6 months
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.
12 months
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.
Baseline
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.
3 months
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.
6 months
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.
12 months
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.
Baseline
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.
3 months
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.
6 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meharry Medical College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Vanderbilt University
Matthew Walker Comprehensive Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-02-1069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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