Nutrition therapy for African American women with type 2 diabetes
Diabetes Medical Nutrition Therapy in Southeastern African American Women
This study is testing whether adding motivational support to nutrition therapy helps African American women with type 2 diabetes manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 291 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Meharry Medical College Academic / other |
| Locations | 2 sites (Nashville, Tennessee and 1 other locations) |
| Trial ID | NCT04971889 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a two-arm randomized controlled design focusing on African American women with type 2 diabetes who are at risk for complications. Participants will be divided into two groups: one receiving diabetes medical nutrition therapy (MNT) and the other receiving MNT along with motivational interviewing (MI). The intervention includes six biweekly group sessions over three months, followed by a maintenance session and a six-month inactive period. The study aims to assess the effectiveness of culturally-adapted MI in enhancing the outcomes of diabetes management.
Who should consider this trial
Good fit: Ideal candidates are African American women diagnosed with type 2 diabetes for at least six months and at risk for complications.
Not a fit: Patients with observed or diagnosed psychotic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diabetes management and reduce complications among African American women.
How similar studies have performed: Other studies have shown success with similar approaches in diabetes management, particularly with culturally tailored interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nashville, Tennessee and 1 other locations
- Matthew Walker Comprehensive Health Center — Nashville, Tennessee, United States (Not_yet_recruiting)
- Meharry Medical College — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Stephania Miller-Hughes, PhD
- Email: smiller@mmc.edu
- Phone: 16153275666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.