Diabetes Medical Nutrition Therapy in Southeastern African American Women
1 other identifier
interventional
291
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Aug 2021
Longer than P75 for not_applicable type-2-diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedStudy Start
First participant enrolled
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedDecember 17, 2025
December 1, 2025
4.2 years
July 13, 2021
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Baseline
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
3 months
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
6 months
Change from Baseline HbA1c
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
12 months
Secondary Outcomes (12)
Body Mass Index
Baseline
Change from Baseline Body Mass Index
3 months
Change from Baseline Body Mass Index
6 months
Change from Baseline Body Mass Index
12 months
LDL Cholesterol
Baseline
- +7 more secondary outcomes
Other Outcomes (20)
Carbohydrate Management Attitude Scale
Baseline
Change from baseline Carbohydrate Management Attitude Scale
3 months
Change from baseline Carbohydrate Management Attitude Scale
6 months
- +17 more other outcomes
Study Arms (2)
Diabetes MNT plus MI
ACTIVE COMPARATOR--Group-based dietary/dietary motivation intervention
Diabetes MNT
ACTIVE COMPARATOR-Group-based dietary intervention
Interventions
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Observed or diagnosed psychotic disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meharry Medical Collegelead
- Patient-Centered Outcomes Research Institutecollaborator
- Matthew Walker Comprehensive Health Centercollaborator
- Vanderbilt Universitycollaborator
Study Sites (2)
Matthew Walker Comprehensive Health Center
Nashville, Tennessee, 37208, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Related Publications (1)
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.
PMID: 36526256BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 22, 2021
Study Start
August 3, 2021
Primary Completion
October 31, 2025
Study Completion
January 31, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share