Diabetes Medical Nutrition Therapy in Southeastern African American Women

Meharry Medical College

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Behavioral: Diabetes MNT; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT04971889

21-02-1069

Details and patient eligibility

About

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.

Enrollment: 291 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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291 participants in 2 patient groups

Diabetes MNT plus MI

Active Comparator group

Description:

--Group-based dietary/dietary motivation intervention

Treatment:

Behavioral: Motivational Interviewing

Behavioral: Diabetes MNT

Diabetes MNT

Active Comparator group

Description:

-Group-based dietary intervention

Treatment:

Behavioral: Diabetes MNT