Diabetes Medical Nutrition Therapy in Southeastern African American Women

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Diabetes MNT; Behavioral: Motivational Interviewing

• Registration Number: NCT04971889
• Lead Sponsor: Meharry Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-22
• Study Start: 2021-08-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 291

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes MNT plus MI	Motivational Interviewing	--Group-based dietary/dietary motivation intervention
Diabetes MNT plus MI	Diabetes MNT	--Group-based dietary/dietary motivation intervention
Diabetes MNT	Diabetes MNT	-Group-based dietary intervention

Primary Outcome Measures

Name	Time	Method
HbA1c	Baseline	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Change from Baseline HbA1c	12 months	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.

Secondary Outcome Measures

Name	Time	Method
LDL Cholesterol	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.
Systolic Blood Pressure	Baseline	A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Body Mass Index	Baseline	Calculated measure of body max index from height/weight measures
Change from baseline LDL Cholesterol	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.
Change from Baseline Body Mass Index	12 months	Calculated measure of body max index from height/weight measures
Change from baseline Systolic Blood Pressure	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.

Trial Locations

Locations (2)

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States

Matthew Walker Comprehensive Health Center; 🇺🇸 Nashville, Tennessee, United States