Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans

NCT04282395 | Active Not Recruiting DMC

• 1 other identifier: R01DK123146
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

African Americans are twice as likely to have type 2 diabetes as non-Hispanic Whites and are less likely to engage in effective diabetes self-management. There is a critical need for intensive lifestyle interventions that address the distress inherent in having the disease and the unique stressors faced by African Americans that may worsen diabetes-related health outcomes. Our program, Resilience-Based Diabetes Self-Management Education and Support, integrates resilience resources with diabetes self-management skills to enable African-American patients to manage the daily demands of the disease and improve long-term adherence to healthy lifestyle choices, thereby reducing the negative health burden of diabetes.

Conditions

Type 2 Diabetes

Keywords

Diabetes self-management; Church setting; African Americans; Health disparities; Resilience

Outcome Measures

Primary Outcomes (6)

• Change from baseline in glycosylated hemoglobin (A1C) at 6 months

  Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.

  Baseline and 6 months

• Change from baseline in glycosylated hemoglobin (A1C) at 12 months

  Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.

  Baseline and 12 months

• Change from baseline in glycosylated hemoglobin (A1C) at 24 months

  Glycosylated hemoglobin (A1C) provides a 3-month average of blood glucose levels and is used to determine changes in blood glucose levels over time. A blood sample is obtained through finger prick capillary blood collection and measured using the A1C Now Self Check (PTS Diagnostics, Indianapolis, IN). The A1C Now Self Check is a commercially available kit designed for home use and requires a finger prick similar to testing blood glucose with a handheld glucometer. The kit is a National Glycohemoglobin Standardization Program certified test that provides results in 5 minutes.

  Baseline and 24 months

• Change from baseline in depressive symptoms at 6 months

  The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.

  Baseline and 6 months

• Change from baseline in depressive symptoms at 12 months

  The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.

  Baseline and 12 months

• Change from baseline in depressive symptoms at 24 months

  The primary mental health outcome, Depressive Symptoms, is measured with the Patient Health Questionnaire-9 (PHQ-9; Cronbach's alpha reliability = .86), which measures the frequency and severity of depressive symptoms. The scale contains 9 items, each of which is rated on a 0-3 scale; higher scores indicate higher levels of depression.

  Baseline and 24 months

Secondary Outcomes (50)

• Change from baseline in dietary intake at 6 months

  Baseline and 6 months

• Change from baseline in dietary intake at 12 months

  Baseline and 12 months

• Change from baseline in physical activity at 6 months

  Baseline and 6 months

• Change from baseline in physical activity at 12 months

  Baseline and 12 months

• Change from baseline in diabetes self-care at 6 months

  Baseline and 6 months

Study Arms (2)

Resilience-Based Diabetes Self-Management Education

EXPERIMENTAL

The RB-DSME structure involves 8 weekly classes, 8 bimonthly support group sessions, and 2 booster sessions. The RB-DSME builds on foundational resilience resources (e.g., self-efficacy, social support), infusing novel resilience resources (e.g., adaptation to stress, finding positive meaning, spiritual coping) into the RB-DSME curriculum.

Behavioral: Resilience-Based Diabetes Self-Management Education

Standard Diabetes Self-Management Education

ACTIVE COMPARATOR

The scope and sequence of the standard diabetes self-management education (DSME) curriculum are aligned with national standards of the American Diabetes Association. DSME groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions.

Behavioral: Standard Diabetes Self-Management Education

Interventions

Resilience-Based Diabetes Self-Management Education BEHAVIORAL

During the group sessions led by professional nurses, participants are provided information and group activities to enable them to more effectively manage their personal diabetes challenges. During the support group sessions, participants discuss personal challenges and solutions to diabetes self-management, using a more informal approach. Booster sessions are held to refresh participants' understanding of how resilience resources can sustain self-management behaviors and maintain improved T2DM health outcomes. The RB-DSME also incorporates cultural characteristics and preferences of African Americans (AAs), to include: * the location in community-based church settings, * recognition of cultural dietary preferences, and * emphasis on cultural/historical significance of resilience in AAs.

Also known as: RB-DSME

Resilience-Based Diabetes Self-Management Education

Standard Diabetes Self-Management Education BEHAVIORAL

Control group sessions, led by professional nurses, cover topics such as: * causes and symptoms of type 2 diabetes, * glucose self-monitoring, * models for and principles of healthy eating, grocery shopping and dining out, * physical activity, * diabetes medications, * managing sick days and stress, and * community resources.

Also known as: DSME

Standard Diabetes Self-Management Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be African American;
• be diagnosed with T2DM;
• be 18 years of age or older;
• have an A1C of 6.5 or higher; and
• not be currently participating in another T2DM management program.

You may not qualify if:

• are pregnant/lactating;
• have medical conditions for which changes in diet and/or physical activity would be contraindicated (e.g., hospitalization for heart disease during the past 6 months, diagnosed heart failure, kidney failure, or peripheral vascular disease requiring special diets and/or restricted physical activity severe enough to preclude walking three times per week, or active tuberculosis); or
• use glucocorticoid containing medication.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Woo J, Lehrer HM, Tabibi D, Cebulske L, Tanaka H, Steinhardt M. The Association of Multidimensional Sleep Health With HbA1c and Depressive Symptoms in African American Adults With Type 2 Diabetes. Psychosom Med. 2024 May 1;86(4):307-314. doi: 10.1097/PSY.0000000000001298.

  PMID: 38724038 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mary A. Steinhardt, EdD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All study participants receive a behavioral intervention that is aimed at managing their diabetes condition, either a standard diabetes self-management education intervention or the experimental resilience-based diabetes self-management education intervention. Due to the nature of behavioral interventions, we are only able to mask the participants, care providers, and dietary recall outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MPI)

Model Details: The primary goal of the project is to test the efficacy of a resilience-based diabetes self-management education intervention (RB-DSME) using a longitudinal, randomized control group design. Thirty-two AA churches are randomly assigned to the RB-DSME experimental group or a standard diabetes self-management education (DSME) control group, run in 8 cohorts over a 5-year period. Each cohort includes 4 churches (2 intervention, 2 control) with 10 participants in each group, run concurrently. Experimental and control groups participate in 8 weekly 1.5-hour classes, followed by 8 bimonthly (every other week) 1.5-hour support group sessions, followed by 2 every other month 1.5-hour booster sessions. Data are collected at baseline and also at 6 and 12 months post study entry; the specific diabetes-related outcomes are also measured at 24 months. During the in-person pause in research due to the pandemic, the intervention groups are held via Zoom and will continue in that format.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 24, 2020
• Study Start: January 25, 2020
• Primary Completion: April 26, 2025
• Study Completion: April 26, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)