Clinical trial NCT04971889: Diabetes Medical Nutrition Therapy in Southeastern African American Women
Official title: Diabetes Medical Nutrition Therapy in Southeastern African American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Matthew Walker Comprehensive Health Center
name: Vanderbilt University
First posted: 2021-07-22
Enrollment: 291
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HbA1c
timeFrame: Baseline
measure: Change from Baseline HbA1c
timeFrame: 3 months
measure: Change from Baseline HbA1c
timeFrame: 6 months
measure: Change from Baseline HbA1c
timeFrame: 12 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline
measure: Change from Baseline Body Mass Index
timeFrame: 3 months
measure: Change from Baseline Body Mass Index
timeFrame: 6 months
measure: Change from Baseline Body Mass Index
timeFrame: 12 months
measure: LDL Cholesterol
timeFrame: Baseline
measure: Change from baseline LDL Cholesterol
timeFrame: 3 months
measure: Change from baseline LDL Cholesterol
timeFrame: 6 months
measure: Change from baseline LDL Cholesterol
timeFrame: 12 months
measure: Systolic Blood Pressure
timeFrame: Baseline
measure: Change from baseline Systolic Blood Pressure
timeFrame: 3 months
measure: Change from baseline Systolic Blood Pressure
timeFrame: 6 months
measure: Change from baseline Systolic Blood Pressure
timeFrame: 12 months
Other outcomes:
measure: Carbohydrate Management Attitude Scale
timeFrame: Baseline
measure: Change from baseline Carbohydrate Management Attitude Scale
timeFrame: 3 months
measure: Change from baseline Carbohydrate Management Attitude Scale
timeFrame: 6 months
measure: Change from baseline Carbohydrate Management Attitude Scale
timeFrame: 12 months
measure: Fat Management Attitude Scale
timeFrame: Baseline
measure: Change from baseline Fat Management Attitude Scale
timeFrame: 3 months
measure: Change from baseline Fat Management Attitude Scale
timeFrame: 6 months
measure: Change from baseline Fat Management Attitude Scale
timeFrame: 12 months
measure: Diabetes Empowerment Scale
timeFrame: Baseline
measure: Change from baseline Diabetes Empowerment Scale
timeFrame: 3 months
measure: Change from baseline Diabetes Empowerment Scale
timeFrame: 6 months
measure: Change from baseline Diabetes Empowerment Scale
timeFrame: 12 months
measure: Problem Areas in Diabetes Scale Questionnaire
timeFrame: Baseline
measure: Change from baseline Problem Areas in Diabetes Scale Questionnaire
timeFrame: 3 months
measure: Change from baseline Problem Areas in Diabetes Scale Questionnaire
timeFrame: 6 months
measure: Change from baseline Problem Areas in Diabetes Scale Questionnaire
timeFrame: 12 months
measure: Situational Obstacles to Dietary Adherence Questionnaire
timeFrame: Baseline
measure: Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
timeFrame: 3 months
measure: Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
timeFrame: 6 months
measure: Change from baseline Situational Obstacles to Dietary Adherence Questionnaire
timeFrame: 12 months
Locations:
city: Nashville
country: United States
facility: Matthew Walker Comprehensive Health Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
References:
citation: Miller ST, Akohoue SA, Murry VM, Tabatabai M, Wilus D, Foxx A. SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women. Contemp Clin Trials. 2023 Feb;125:107052. doi: 10.1016/j.cct.2022.107052. Epub 2022 Dec 13.