Improving Health Outcomes in African Americans With Type 2 Diabetes: A Culturally Tailored, Resilience-Based Diabetes Self-Management Education (RB-DSME) Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Texas at Austin
- Enrollment
- 284
- Locations
- 1
- Primary Endpoint
- Change from baseline in glycosylated hemoglobin (A1C) at 6 months
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
Type 2 diabetes mellitus (T2DM) costs the U.S. $327 billion annually, representing a 26% increase from 2012 to 2017. African Americans (AAs) are twice as likely to have T2DM as non-Hispanic Whites, have worse health outcomes, and are less likely to engage in self-management behaviors. Interventions addressing these disparities are urgently needed. Among AAs, T2DM-associated stress is often compounded by general life stress, which further constrains diabetes self-management and is associated with poor glucose control (A1C) and complications such as depression. The impact of stress on diabetes self-management and health outcomes may be attenuated by resilience: a resolve to succeed despite adversities. Even with evidence supporting resilience resources benefiting other health outcomes, there is a dearth of evidence-based T2DM resilience interventions. Building on our promising pilot work, this study uses our culturally tailored, theory-derived Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention to help participants manage the psychosocial and behavioral demands of the disease. The study is designed as a 24-month, 2-arm, cluster randomized clinical trial and involves assigning AA churches to the RB-DSME or a standard DSME condition. Both groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions. To investigate the efficacy of RB-DSME, we compare RB-DSME to DSME on T2DM physical and mental health outcomes. To inform more targeted future interventions, we examine indirect effects of RB-DSME (vs DSME) on resilience resources, such as stress and coping. We also examine indirect effects of resilience resources on T2DM health outcomes through self-management behaviors, such as diet and exercise. The specific aims of the study are: Aim 1: To compare T2DM physical health outcomes (primary outcome: A1C) and T2DM mental health outcomes (primary outcome: depressive symptoms) in the RB-DSME group vs DSME group at 6, 12, and 24 months. H1: Compared with DSME, RB-DSME will have improved T2DM physical health outcomes. H2: Compared with DSME, RB-DSME will have improved T2DM mental health outcomes. Aim 2: To test indirect effects of RB-DSME (vs DSME) on T2DM physical and mental health outcomes via resilience resources, self-management behaviors, and HPA axis function. H3: RB-DSME (vs DSME) will improve resilience resources at 6 and 12 months, which will improve T2DM physical and mental health outcomes at 12 and 24 months. H4: RB-DSME (vs DSME) driven improvements in resilience resources at 6 months will improve self-management and HPA axis function at 12 months, which will improve T2DM outcomes at 24 months. The project will provide crucial guidance for addressing the T2DM burden among AAs by establishing the efficacy of the RB-DSME and identifying behavioral and biological mechanisms by which the program affects T2DM health outcomes. The long-term goal is to enable AAs to effectively manage T2DM and thus avoid its serious consequences, via RB-DSME interventions in a range of community settings.
Investigators
Mary Steinhardt
Principal Investigator (MPI)
University of Texas at Austin
Eligibility Criteria
Inclusion Criteria
- •Participants must:
- •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.
Exclusion Criteria
- •Individuals will be excluded if they:
- •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.
Outcomes
Primary Outcomes
Change from baseline in glycosylated hemoglobin (A1C) at 6 months
Time Frame: Baseline and 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.
Change from baseline in depressive symptoms at 12 months
Time Frame: Baseline and 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.
Change from baseline in glycosylated hemoglobin (A1C) at 24 months
Time Frame: Baseline and 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.
Change from baseline in glycosylated hemoglobin (A1C) at 12 months
Time Frame: Baseline and 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.
Change from baseline in depressive symptoms at 6 months
Time Frame: Baseline and 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.
Change from baseline in depressive symptoms at 24 months
Time Frame: Baseline and 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.
Secondary Outcomes
- Change from baseline in physical activity at 6 months(Baseline and 6 months)
- Change from baseline in dietary intake at 6 months(Baseline and 6 months)
- Change from baseline in fasting blood glucose levels at 6 months(Baseline and 6 months)
- Change from baseline in cholesterol levels at 12 months(Baseline and 12 months)
- Change from baseline in cholesterol levels at 24 months(Baseline and 24 months)
- Change from baseline in physiological stress (HPA axis function) at 6 months(Baseline and 6 months)
- Change from baseline in physiological stress (HPA axis function) at 12 months(Baseline and 12 months)
- Change from baseline in fasting blood glucose levels at 12 months(Baseline and 12 months)
- Change from baseline in diabetes self-care at 6 months(Baseline and 6 months)
- Change from baseline in diabetes self-care at 12 months(Baseline and 12 months)
- Change from baseline in waist circumference at 24 months(Baseline and 24 months)
- Change from baseline in dietary intake at 12 months(Baseline and 12 months)
- Change from baseline in fasting blood glucose levels at 24 months(Baseline and 24 months)
- Change from baseline in triglycerides at 6 months(Baseline and 6 months)
- Change from baseline in body mass index (BMI) at 6 months(Baseline and 6 months)
- Change from baseline in blood pressure at 24 months(Baseline and 24 months)
- Change from baseline in sleep quantity and quality at 6 months(Baseline and 6 months)
- Change from baseline in physical activity at 12 months(Baseline and 12 months)
- Change from baseline in cholesterol levels at 6 months(Baseline and 6 months)
- Change from baseline in diabetes distress at 24 months(Baseline and 24 months)
- Change from baseline in finding positive meaning at 12 months(Baseline and 12 months)
- Change from baseline in triglycerides at 12 months(Baseline and 12 months)
- Change from baseline in triglycerides at 24 months(Baseline and 24 months)
- Change from baseline in body mass index (BMI) at 12 months(Baseline and 12 months)
- Change from baseline in body mass index (BMI) at 24 months(Baseline and 24 months)
- Change from baseline in waist circumference at 6 months(Baseline and 6 months)
- Change from baseline in waist circumference at 12 months(Baseline and 12 months)
- Change from baseline in diabetes distress at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 24 months(Baseline and 24 months)
- Change from baseline in spiritual coping at 12 months(Baseline and 12 months)
- Change from baseline in adaptive coping strategies at 12 months(Baseline and 12 months)
- Change from baseline in blood pressure at 6 months(Baseline and 6 months)
- Change from baseline in blood pressure at 12 months(Baseline and 12 months)
- Change from baseline in general perceived stress at 6 months(Baseline and 6 months)
- Change from baseline in self-efficacy at 6 months(Baseline and 6 months)
- Change from baseline in finding positive meaning at 6 months(Baseline and 6 months)
- Change from baseline in adaptation to stress at 12 months(Baseline and 12 months)
- Change from baseline in diabetes distress at 6 months(Baseline and 6 months)
- Change from baseline in sleep quantity and quality at 12 months(Baseline and 12 months)
- Change from baseline in spiritual coping at 6 months(Baseline and 6 months)
- Change from baseline in self-efficacy at 12 months(Baseline and 12 months)
- Change from baseline in adaptive coping strategies at 6 months(Baseline and 6 months)
- Change from baseline in adaptation to stress at 6 months(Baseline and 6 months)
- Change from baseline in coping with discrimination at 6 months(Baseline and 6 months)
- Change from baseline in coping with discrimination at 12 months(Baseline and 12 months)
- Change from baseline in emotional regulation at 6 months(Baseline and 6 months)
- Change from baseline in emotional regulation at 12 months(Baseline and 12 months)
- Change from baseline in social support at 6 months(Baseline and 6 months)
- Change from baseline in social support at 12 months(Baseline and 12 months)