Diabetes Medical Nutrition Therapy in Southeastern African American Women

Type 2 Diabetes Clinical Trial

Official title:

Diabetes Medical Nutrition Therapy in Southeastern African American Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971889
• Other study ID #: 21-02-1069
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Meharry Medical College
• Contact: Stephania Miller-Hughes, PhD
• Phone: 16153275666
• Email: smiller[@]mmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 291
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

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
• Motivational Interviewing
Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise

Locations

Country	Name	City	State
United States	Matthew Walker Comprehensive Health Center	Nashville	Tennessee
United States	Meharry Medical College	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
Meharry Medical College	Matthew Walker Comprehensive Health Center, Patient-Centered Outcomes Research Institute, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	Baseline
Other	Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	3 months
Other	Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	6 months
Other	Change from baseline Carbohydrate Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for carbohydrate management.	12 months
Other	Fat Management Attitude Scale	Uses a Likert question format (n=12) and assesses attitudes and motivation for dietary fat management.	Baseline
Other	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
Other	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
Other	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
Other	Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	Baseline
Other	Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	3 months
Other	Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	6 months
Other	Change from baseline Diabetes Empowerment Scale	Uses a Likert question format (n=8) and assesses motivation for overall diabetes self-care.	12 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	Baseline
Primary	Change from Baseline HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	3 months
Primary	Change from Baseline HbA1c	Widely-utilized high performance liquid chromatography methods will be used to measure glycemic control from whole blood samples.	6 months
Primary	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	Body Mass Index	Calculated measure of body max index from height/weight measures	Baseline
Secondary	Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	3 months
Secondary	Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	6 months
Secondary	Change from Baseline Body Mass Index	Calculated measure of body max index from height/weight measures	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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