Diabetes Medical Nutrition Therapy in Southeastern African American Women

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Diabetes MNT; Behavioral: Motivational Interviewing

• Study Type: Interventional
• Enrollment (Anticipated): 291
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephania Miller-Hughes, PhD; Phone Number: 16153275666; Email: smiller@mmc.edu

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • Recruiting
      • Meharry Medical College
      • Contact: Stephania Miller-Hughes, PhD, MS, MSCI; Email: smiller@mmc.edu
    • Nashville, Tennessee, United States, 37208
      • Not yet recruiting
      • Matthew Walker Comprehensive Health Center
      • Contact: Katina Beard, MSPH; Email: kbeard@mwchc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	Baseline
Change from Baseline HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	3 months
Change from Baseline HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	6 months
Change from Baseline HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Calculated measure of body max index from height/weight measures	Baseline
Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	3 months
Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	6 months
Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	12 months
LDL Cholesterol	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.	Baseline
Change from baseline LDL Cholesterol	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.	3 months
Change from baseline LDL Cholesterol	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.	6 months
Change from baseline LDL Cholesterol	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.	12 months
Systolic Blood Pressure	A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.	Baseline
Change from baseline Systolic Blood Pressure	A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.	3 months
Change from baseline Systolic Blood Pressure	A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.	6 months
Change from baseline Systolic Blood Pressure	A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	Baseline
Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	3 months
Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	6 months
Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	12 months
Fat Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.	Baseline
Change from baseline Fat Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.	3 months
Change from baseline Fat Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.	6 months
Change from baseline Fat Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.	12 months
Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	Baseline
Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	3 months
Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	6 months
Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	12 months
Problem Areas in Diabetes Scale Questionnaire	Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.	Baseline
Change from baseline Problem Areas in Diabetes Scale Questionnaire	Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.	3 months
Change from baseline Problem Areas in Diabetes Scale Questionnaire	Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.	6 months
Change from baseline Problem Areas in Diabetes Scale Questionnaire	Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.	12 months
Situational Obstacles to Dietary Adherence Questionnaire	Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options.	Baseline
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire	Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options.	3 months
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire	Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options.	6 months
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire	Uses a Likert question (n=6) format and assesses self-efficacy in adhering to dietary recommendations and managing situations that make adherence challenging (e.g., social activities including few healthy food options.	12 months

Collaborators and Investigators

• Sponsor: Meharry Medical College
• Collaborators: Patient-Centered Outcomes Research Institute; Vanderbilt University; Matthew Walker Comprehensive Health Center

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 21-02-1069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No