Type 2 DiabetesNCT04971889
Diabetes Medical Nutrition Therapy in Southeastern African American Women
A study testing Diabetes MNT and Motivational Interviewing in people with Type 2 Diabetes, run by Meharry Medical College at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Diabetes MNT and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2021to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- --Observed or diagnosed psychotic disorders
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Matthew Walker Comprehensive Health Center
Nashville, Tennessee, 37208
Meharry Medical College
Nashville, Tennessee, 37208
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Diabetes MNT, Motivational Interviewing
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes MNTBehavioural
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 InterviewingBehavioural
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
| Study group | Role | What they receive |
|---|---|---|
| Diabetes MNT plus MI | Active comparator | --Group-based dietary/dietary motivation intervention Receives: Behavioral: Diabetes MNT; Behavioral: Motivational Interviewing |
| Diabetes MNT | Active comparator | -Group-based dietary intervention Receives: Behavioral: Diabetes MNT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Measured: Baseline
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Measured: 3 months
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Measured: 6 months
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Measured: 12 months
Secondary outcomes (12)
Body Mass Index
Calculated measure of body max index from height/weight measures
Measured: Baseline
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
Measured: 3 months
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
Measured: 6 months
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start3 Aug 2021
- Primary completion31 Oct 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University
- Responsible party
- Principal investigator, Stephania T. Miller-Hughes, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971889
- Sponsor's protocol ID
- 21-02-1069
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller ST, Akohoue SA, Murry VM, Tabatabai M, Wilus D, Foxx A. SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women. Contemp Clin Trials. 2023 Feb;125:107052. doi: 10.1016/j.cct.2022.107052. Epub 2022 Dec 13.
PubMed 36526256
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Medical Nutrition Therapy in Southeastern African American Women
- ClinicalTrials.gov ID
- NCT04971889
- Acronym / sponsor ID
- 21-02-1069
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes MNT plus MI | Active comparator | Behavioral: Diabetes MNT, Behavioral: Motivational Interviewing--Group-based dietary/dietary motivation intervention |
| Diabetes MNT | Active comparator | Behavioral: Diabetes MNT-Group-based dietary intervention |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- --Observed or diagnosed psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes MNTGroup-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake | Behavioural | Diabetes MNT, Diabetes MNT plus MI |
| Motivational InterviewingGroup-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise | Behavioural | Diabetes MNT plus MI |
Primary outcome
HbA1c
Time frame: Baseline
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
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.
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.
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 secondary outcomes
Body Mass Index
Time frame: Baseline
Change from Baseline Body Mass Index
Time frame: 3 months
Change from Baseline Body Mass Index
Time frame: 6 months
Change from Baseline Body Mass Index
Time frame: 12 months
LDL Cholesterol
Time frame: Baseline
Change from baseline LDL Cholesterol
Time frame: 3 months
Change from baseline LDL Cholesterol
Time frame: 6 months
Change from baseline LDL Cholesterol
Time frame: 12 months
Systolic Blood Pressure
Time frame: Baseline
Change from baseline Systolic Blood Pressure
Time frame: 3 months
Change from baseline Systolic Blood Pressure
Time frame: 6 months
Change from baseline Systolic Blood Pressure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 36526256Miller ST, Akohoue SA, Murry VM, Tabatabai M, Wilus D, Foxx A. SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women. Contemp Clin Trials. 2023 Feb;125:107052. doi: 10.1016/j.cct.2022.107052. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes MNT and Motivational Interviewing in people with Type 2 Diabetes, run by Meharry Medical College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.