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Diabetes Medical Nutrition Therapy in Southeastern African American Women

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes MNT
Motivational Interviewing
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Matthew Walker Comprehensive Health Center
  • Meharry Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Diabetes MNT plus MI

Diabetes MNT

Arm Description

--Group-based dietary/dietary motivation intervention

-Group-based dietary intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body Mass Index
Calculated measure of body max index from height/weight measures
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
Change from Baseline Body Mass Index
Calculated measure of body max index from height/weight measures
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 13, 2021
Last Updated
August 23, 2022
Sponsor
Meharry Medical College
Collaborators
Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04971889
Brief Title
Diabetes Medical Nutrition Therapy in Southeastern African American Women
Official Title
Diabetes Medical Nutrition Therapy in Southeastern African American Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meharry Medical College
Collaborators
Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
291 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes MNT plus MI
Arm Type
Active Comparator
Arm Description
--Group-based dietary/dietary motivation intervention
Arm Title
Diabetes MNT
Arm Type
Active Comparator
Arm Description
-Group-based dietary intervention
Intervention Type
Behavioral
Intervention Name(s)
Diabetes MNT
Intervention Description
Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
Primary Outcome Measure Information:
Title
HbA1c
Description
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Time Frame
Baseline
Title
Change from Baseline HbA1c
Description
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Time Frame
3 months
Title
Change from Baseline HbA1c
Description
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Time Frame
6 months
Title
Change from Baseline HbA1c
Description
Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Calculated measure of body max index from height/weight measures
Time Frame
Baseline
Title
Change from Baseline Body Mass Index
Description
Calculated measure of body max index from height/weight measures
Time Frame
3 months
Title
Change from Baseline Body Mass Index
Description
Calculated measure of body max index from height/weight measures
Time Frame
6 months
Title
Change from Baseline Body Mass Index
Description
Calculated measure of body max index from height/weight measures
Time Frame
12 months
Title
LDL Cholesterol
Description
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.
Time Frame
Baseline
Title
Change from baseline LDL Cholesterol
Description
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.
Time Frame
3 months
Title
Change from baseline LDL Cholesterol
Description
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.
Time Frame
6 months
Title
Change from baseline LDL Cholesterol
Description
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.
Time Frame
12 months
Title
Systolic Blood Pressure
Description
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Time Frame
Baseline
Title
Change from baseline Systolic Blood Pressure
Description
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Time Frame
3 months
Title
Change from baseline Systolic Blood Pressure
Description
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Time Frame
6 months
Title
Change from baseline Systolic Blood Pressure
Description
A sphygmometer will be assessed to assess systolic blood pressure fifteen minutes after participant is in a seated position with their arm elevated.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Carbohydrate Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
Time Frame
Baseline
Title
Change from baseline Carbohydrate Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
Time Frame
3 months
Title
Change from baseline Carbohydrate Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
Time Frame
6 months
Title
Change from baseline Carbohydrate Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.
Time Frame
12 months
Title
Fat Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
Time Frame
Baseline
Title
Change from baseline Fat Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
Time Frame
3 months
Title
Change from baseline Fat Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
Time Frame
6 months
Title
Change from baseline Fat Management Attitude Scale
Description
Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.
Time Frame
12 months
Title
Diabetes Empowerment Scale
Description
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
Time Frame
Baseline
Title
Change from baseline Diabetes Empowerment Scale
Description
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
Time Frame
3 months
Title
Change from baseline Diabetes Empowerment Scale
Description
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
Time Frame
6 months
Title
Change from baseline Diabetes Empowerment Scale
Description
Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.
Time Frame
12 months
Title
Problem Areas in Diabetes Scale Questionnaire
Description
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
Time Frame
Baseline
Title
Change from baseline Problem Areas in Diabetes Scale Questionnaire
Description
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
Time Frame
3 months
Title
Change from baseline Problem Areas in Diabetes Scale Questionnaire
Description
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
Time Frame
6 months
Title
Change from baseline Problem Areas in Diabetes Scale Questionnaire
Description
Uses a Likert question (n=20) format and assesses patients' problems in applying various self-care areas, including dietary self-care skills.
Time Frame
12 months
Title
Situational Obstacles to Dietary Adherence Questionnaire
Description
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.
Time Frame
Baseline
Title
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
Description
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.
Time Frame
3 months
Title
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
Description
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.
Time Frame
6 months
Title
Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-identification
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephania Miller-Hughes, PhD
Phone
16153275666
Email
smiller@mmc.edu
Facility Information:
Facility Name
Matthew Walker Comprehensive Health Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katina Beard, MSPH
Email
kbeard@mwchc.org
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephania Miller-Hughes, PhD, MS, MSCI
Email
smiller@mmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Medical Nutrition Therapy in Southeastern African American Women

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