NCT04971889

Diabetes Medical Nutrition Therapy in Southeastern African American Women

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (estimated)
• Sponsor: Meharry Medical College · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-03
• Primary completion: 2025-10-31
• Completion: 2026-01-31
• First posted: 2021-07-22
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States