Diabetes Medical Nutrition Therapy in Southeastern African American Women

Purpose

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.

Condition

  • Type 2 Diabetes

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Diabetes MNT plus MI 		--Group-based dietary/dietary motivation intervention
  • 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
Active Comparator
Diabetes MNT 		-Group-based dietary intervention
  • 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

Recruiting Locations

Meharry Medical College
Nashville 4644585, Tennessee 4662168 37208
Contact:
Stephania Miller-Hughes, PhD, MS, MSCI
smiller@mmc.edu

More Details

Status
Recruiting
Sponsor
Meharry Medical College

Study Contact

Stephania Miller-Hughes, PhD
16153275666
smiller@mmc.edu