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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.