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

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ClinicalTrials.gov Identifier: NCT04282395
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Mary Steinhardt, University of Texas at Austin

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, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Resilience-Based Diabetes Self-Management Education Behavioral: Standard Diabetes Self-Management Education Not Applicable

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 3, 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 3, 6, and 12 months, which will improve T2DM physical and mental health outcomes at 6, 12, and 24 months.

H4: RB-DSME (vs DSME) driven improvements in resilience resources at 3 and 6 months will improve self-management and HPA axis function at 6 and 12 months, which will improve T2DM outcomes at 12 and 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 2-hour classes, followed by 8 bimonthly (every other week) 2-hour support group sessions, followed by 2 every other month 2-hour booster sessions. Data are collected at baseline and also at 3, 6, and 12 months post study entry; the specific diabetes-related outcomes are also measured at 24 months.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Improving Health Outcomes in African Americans With Type 2 Diabetes: A Culturally Tailored, Resilience-Based Diabetes Self-Management Education (RB-DSME) Intervention
Actual Study Start Date : January 25, 2020
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resilience-Based Diabetes Self-Management Education
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

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.
Other Name: RB-DSME

Active Comparator: Standard Diabetes Self-Management Education
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

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.
Other Name: DSME




Primary Outcome Measures :
  1. Change from baseline in glycosylated hemoglobin (A1C) at 3 months [ Time Frame: Baseline and 3 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 on a DCA Vantage Analyzer (Siemens, Tarrytown, NY). This method meets the National Glycohemoglobin Standardization Program certification criteria for a total coefficient of variation <3% in the clinically relevant range.

  2. 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 on a DCA Vantage Analyzer (Siemens, Tarrytown, NY). This method meets the National Glycohemoglobin Standardization Program certification criteria for a total coefficient of variation <3% in the clinically relevant range.

  3. 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 on a DCA Vantage Analyzer (Siemens, Tarrytown, NY). This method meets the National Glycohemoglobin Standardization Program certification criteria for a total coefficient of variation <3% in the clinically relevant range.

  4. 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 on a DCA Vantage Analyzer (Siemens, Tarrytown, NY). This method meets the National Glycohemoglobin Standardization Program certification criteria for a total coefficient of variation <3% in the clinically relevant range.

  5. Change from baseline in depressive symptoms at 3 months [ Time Frame: Baseline and 3 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.

  6. 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.

  7. 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.

  8. 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 Outcome Measures :
  1. Change from baseline in dietary intake at 3 months [ Time Frame: Baseline and 3 months ]
    Dietary intake is measured by trained interviewers who collect two 24-hour dietary recalls using the multiple pass technique by telephone (ensuring data for 1 weekend and 1 weekday) within 10 days of each data collection session (baseline, 3, 6, 12 months). All recall data will be analyzed using the Nutrition Data System for Research (NDS-R; 2012, University of Minnesota). The NDS-R calculates key dietary variables including energy, macronutrients, total and added sugar, fiber, glycemic index, food/beverages servings/day, and a Healthy Eating Index (HEI).

  2. Change from baseline in dietary intake at 6 months [ Time Frame: Baseline and 6 months ]
    Dietary intake is measured by trained interviewers who collect two 24-hour dietary recalls using the multiple pass technique by telephone (ensuring data for 1 weekend and 1 weekday) within 10 days of each data collection session (baseline, 3, 6, 12 months). All recall data will be analyzed using the Nutrition Data System for Research (NDS-R; 2012, University of Minnesota). The NDS-R calculates key dietary variables including energy, macronutrients, total and added sugar, fiber, glycemic index, food/beverages servings/day, and a Healthy Eating Index (HEI).

  3. Change from baseline in dietary intake at 12 months [ Time Frame: Baseline and 12 months ]
    Dietary intake is measured by trained interviewers who collect two 24-hour dietary recalls using the multiple pass technique by telephone (ensuring data for 1 weekend and 1 weekday) within 10 days of each data collection session (baseline, 3, 6, 12 months). All recall data will be analyzed using the Nutrition Data System for Research (NDS-R; 2012, University of Minnesota). The NDS-R calculates key dietary variables including energy, macronutrients, total and added sugar, fiber, glycemic index, food/beverages servings/day, and a Healthy Eating Index (HEI).

  4. Change from baseline in physical activity at 3 months [ Time Frame: Baseline and 3 months ]
    Physical activity is measured with accelerometers (wGT3X-BT, Actigraph LLC, Pensacola, FL). Physical activity is measured for 7 days in the same week as the in-person data collection session and the dietary recalls (baseline, 3, 6, 12 months). All accelerometer data are immediately downloaded and wear time assessed. If the participant does not have at least 4 days with ≥8 hours of wear time, the accelerometer is re-issued to the participant. The following data from all acceptable days are available: minutes and percent time spent in light physical activity, moderate to vigorous physical activity, and sedentary behavior. Adult cutoffs are used to quantify and classify accelerometry data.

  5. Change from baseline in physical activity at 6 months [ Time Frame: Baseline and 6 months ]
    Physical activity is measured with accelerometers (wGT3X-BT, Actigraph LLC, Pensacola, FL). Physical activity is measured for 7 days in the same week as the in-person data collection session and the dietary recalls (baseline, 3, 6, 12 months). All accelerometer data are immediately downloaded and wear time assessed. If the participant does not have at least 4 days with ≥8 hours of wear time, the accelerometer is re-issued to the participant. The following data from all acceptable days are available: minutes and percent time spent in light physical activity, moderate to vigorous physical activity, and sedentary behavior. Adult cutoffs are used to quantify and classify accelerometry data.

  6. Change from baseline in physical activity at 12 months [ Time Frame: Baseline and 12 months ]
    Physical activity is measured with accelerometers (wGT3X-BT, Actigraph LLC, Pensacola, FL). Physical activity is measured for 7 days in the same week as the in-person data collection session and the dietary recalls (baseline, 3, 6, 12 months). All accelerometer data are immediately downloaded and wear time assessed. If the participant does not have at least 4 days with ≥8 hours of wear time, the accelerometer is re-issued to the participant. The following data from all acceptable days are available: minutes and percent time spent in light physical activity, moderate to vigorous physical activity, and sedentary behavior. Adult cutoffs are used to quantify and classify accelerometry data.

  7. Change from baseline in diabetes self-care at 3 months [ Time Frame: Baseline and 3 months ]
    Diabetes self-care is measured by the 12-item Self-Care Inventory-Revised (SCI-R), which assesses perceived diabetes self-care adherence. The SCI-R is designed on a 1 to 5 Likert-type scale from 1 (never do it) to 5 (always do this). Total possible scores range from 12 to 60, with higher scores indicating enhanced diabetes self-care. The Cronbach's alpha reliability = .87.

  8. Change from baseline in diabetes self-care at 6 months [ Time Frame: Baseline and 6 months ]
    Diabetes self-care is measured by the 12-item Self-Care Inventory-Revised (SCI-R), which assesses perceived diabetes self-care adherence. The SCI-R is designed on a 1 to 5 Likert-type scale from 1 (never do it) to 5 (always do this). Total possible scores range from 12 to 60, with higher scores indicating enhanced diabetes self-care. The Cronbach's alpha reliability = .87.

  9. Change from baseline in diabetes self-care at 12 months [ Time Frame: Baseline and 12 months ]
    Diabetes self-care is measured by the 12-item Self-Care Inventory-Revised (SCI-R), which assesses perceived diabetes self-care adherence. The SCI-R is designed on a 1 to 5 Likert-type scale from 1 (never do it) to 5 (always do this). Total possible scores range from 12 to 60, with higher scores indicating enhanced diabetes self-care. The Cronbach's alpha reliability = .87.

  10. Change from baseline in physiological stress (HPA axis function) at 6 months [ Time Frame: Baseline and 6 months ]
    Hair cortisol and DHEA are assessed by collecting proximal 3 cm of scalp-near hair. Once all hair samples are collected for each cohort, they are shipped to and analyzed by the Behavioral Immunology and Endocrinology Lab (BIEL) at the University of Colorado-Denver Anschutz Medical Campus. Steroid levels are determined using a commercial high sensitivity enzyme-linked immunoassay kit (Salimetrics LLC, State College, PA), per manufacturer's protocol. BIEL is validated for hair steroid analysis. A professional hair stylist collects the samples to ease any participant concerns.

  11. Change from baseline in physiological stress (HPA axis function) at 12 months [ Time Frame: Baseline and 12 months ]
    Hair cortisol and DHEA are assessed by collecting proximal 3 cm of scalp-near hair. Once all hair samples are collected for each cohort, they are shipped to and analyzed by the Behavioral Immunology and Endocrinology Lab (BIEL) at the University of Colorado-Denver Anschutz Medical Campus. Steroid levels are determined using a commercial high sensitivity enzyme-linked immunoassay kit (Salimetrics LLC, State College, PA), per manufacturer's protocol. BIEL is validated for hair steroid analysis. A professional hair stylist collects the samples to ease any participant concerns.

  12. Change from baseline in fasting blood glucose levels at 3 months [ Time Frame: Baseline and 3 months ]
    Fasting plasma concentrations of glucose is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  13. Change from baseline in fasting blood glucose levels at 6 months [ Time Frame: Baseline and 6 months ]
    Fasting plasma concentrations of glucose is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  14. Change from baseline in fasting blood glucose levels at 12 months [ Time Frame: Baseline and 12 months ]
    Fasting plasma concentrations of glucose is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  15. Change from baseline in fasting blood glucose levels at 24 months [ Time Frame: Baseline and 24 months ]
    Fasting plasma concentrations of glucose is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  16. Change from baseline in cholesterol levels at 3 months [ Time Frame: Baseline and 3 months ]
    Cholesterol (including total, LDL, and HDL) is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA)

  17. Change from baseline in cholesterol levels at 6 months [ Time Frame: Baseline and 6 months ]
    Cholesterol (including total, LDL, and HDL) is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA)

  18. Change from baseline in cholesterol levels at 12 months [ Time Frame: Baseline and 12 months ]
    Cholesterol (including total, LDL, and HDL) is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA)

  19. Change from baseline in cholesterol levels at 24 months [ Time Frame: Baseline and 24 months ]
    Cholesterol (including total, LDL, and HDL) is determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA)

  20. Change from baseline in triglycerides at 3 months [ Time Frame: Baseline and 3 months ]
    Fasting plasma concentrations of triglycerides are determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  21. Change from baseline in triglycerides at 6 months [ Time Frame: Baseline and 6 months ]
    Fasting plasma concentrations of triglycerides are determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  22. Change from baseline in triglycerides at 12 months [ Time Frame: Baseline and 12 months ]
    Fasting plasma concentrations of triglycerides are determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  23. Change from baseline in triglycerides at 24 months [ Time Frame: Baseline and 24 months ]
    Fasting plasma concentrations of triglycerides are determined through finger prick capillary blood collection and analyzed enzymatically with Alere reagent on a Cholestech LDX analyzer (Alere, Waltham, MA).

  24. Change from baseline in body mass index (BMI) at 3 months [ Time Frame: Baseline and 3 months ]
    Body mass index (BMI) is measured with the following formula: BMI = (weight in kg)/(height in m)2. For the calculation, body weight is measured using a Tanita Professional Digital Scale (Model BF350). Participants wear street clothes and no shoes; coats and belts are removed. Height is determined using a portable stadiometer, Seca 214.

  25. Change from baseline in body mass index (BMI) at 6 months [ Time Frame: Baseline and 6 months ]
    Body mass index (BMI) is measured with the following formula: BMI = (weight in kg)/(height in m)2. For the calculation, body weight is measured using a Tanita Professional Digital Scale (Model BF350). Participants wear street clothes and no shoes; coats and belts are removed. Height is determined using a portable stadiometer, Seca 214.

  26. Change from baseline in body mass index (BMI) at 12 months [ Time Frame: Baseline and 12 months ]
    Body mass index (BMI) is measured with the following formula: BMI = (weight in kg)/(height in m)2. For the calculation, body weight is measured using a Tanita Professional Digital Scale (Model BF350). Participants wear street clothes and no shoes; coats and belts are removed. Height is determined using a portable stadiometer, Seca 214.

  27. Change from baseline in body mass index (BMI) at 24 months [ Time Frame: Baseline and 24 months ]
    Body mass index (BMI) is measured with the following formula: BMI = (weight in kg)/(height in m)2. For the calculation, body weight is measured using a Tanita Professional Digital Scale (Model BF350). Participants wear street clothes and no shoes; coats and belts are removed. Height is determined using a portable stadiometer, Seca 214.

  28. Change from baseline in waist circumference at 3 months [ Time Frame: Baseline and 3 months ]
    Waist circumference is measured to the nearest 0.1 cm using a non-stretchable standard tape measure attached to a spring balance, 0.1 cm above the iliac crest on a horizontal plane.

  29. Change from baseline in waist circumference at 6 months [ Time Frame: Baseline and 6 months ]
    Waist circumference is measured to the nearest 0.1 cm using a non-stretchable standard tape measure attached to a spring balance, 0.1 cm above the iliac crest on a horizontal plane.

  30. Change from baseline in waist circumference at 12 months [ Time Frame: Baseline and 12 months ]
    Waist circumference is measured to the nearest 0.1 cm using a non-stretchable standard tape measure attached to a spring balance, 0.1 cm above the iliac crest on a horizontal plane.

  31. Change from baseline in waist circumference at 24 months [ Time Frame: Baseline and 24 months ]
    Waist circumference is measured to the nearest 0.1 cm using a non-stretchable standard tape measure attached to a spring balance, 0.1 cm above the iliac crest on a horizontal plane.

  32. Change from baseline in blood pressure at 3 months [ Time Frame: Baseline and 3 months ]
    Blood pressure (systolic and diastolic) is measured with an Omron HEM-907XL Automatic Inflation Blood Pressure Monitor (Omincron, Philadelphia, PA). Following a 5-minute rest period, the monitor takes 3 consecutive readings 1 minute apart and displays the average, following American Heart Association guidelines.

  33. Change from baseline in blood pressure at 6 months [ Time Frame: Baseline and 6 months ]
    Blood pressure (systolic and diastolic) is measured with an Omron HEM-907XL Automatic Inflation Blood Pressure Monitor (Omincron, Philadelphia, PA). Following a 5-minute rest period, the monitor takes 3 consecutive readings 1 minute apart and displays the average, following American Heart Association guidelines.

  34. Change from baseline in blood pressure at 12 months [ Time Frame: Baseline and 12 months ]
    Blood pressure (systolic and diastolic) is measured with an Omron HEM-907XL Automatic Inflation Blood Pressure Monitor (Omincron, Philadelphia, PA). Following a 5-minute rest period, the monitor takes 3 consecutive readings 1 minute apart and displays the average, following American Heart Association guidelines.

  35. Change from baseline in blood pressure at 24 months [ Time Frame: Baseline and 24 months ]
    Blood pressure (systolic and diastolic) is measured with an Omron HEM-907XL Automatic Inflation Blood Pressure Monitor (Omincron, Philadelphia, PA). Following a 5-minute rest period, the monitor takes 3 consecutive readings 1 minute apart and displays the average, following American Heart Association guidelines.

  36. Change from baseline in diabetes distress at 3 months [ Time Frame: Baseline and 3 months ]
    Diabetes distress is measured with the 4-item Diabetes Distress Scale (Chronbach's alpha reliability = .90), assessing the emotional burden due to having T2DM. Each item is rated from 1 (not a problem) to 6 (serious problem). Total possible scores range from 4 to 24, with higher scores indicating more distress with the burden of diabetes.

  37. Change from baseline in diabetes distress at 6 months [ Time Frame: Baseline and 6 months ]
    Diabetes distress is measured with the 4-item Diabetes Distress Scale (Chronbach's alpha reliability = .90), assessing the emotional burden due to having T2DM. Each item is rated from 1 (not a problem) to 6 (serious problem). Total possible scores range from 4 to 24, with higher scores indicating more distress with the burden of diabetes.

  38. Change from baseline in diabetes distress at 12 months [ Time Frame: Baseline and 12 months ]
    Diabetes distress is measured with the 4-item Diabetes Distress Scale (Chronbach's alpha reliability = .90), assessing the emotional burden due to having T2DM. Each item is rated from 1 (not a problem) to 6 (serious problem). Total possible scores range from 4 to 24, with higher scores indicating more distress with the burden of diabetes.

  39. Change from baseline in diabetes distress at 24 months [ Time Frame: Baseline and 24 months ]
    Diabetes distress is measured with the 4-item Diabetes Distress Scale (Chronbach's alpha reliability = .90), assessing the emotional burden due to having T2DM. Each item is rated from 1 (not a problem) to 6 (serious problem). Total possible scores range from 4 to 24, with higher scores indicating more distress with the burden of diabetes.

  40. Change from baseline in general perceived stress at 3 months [ Time Frame: Baseline and 3 months ]
    General stress is assessed with the 10-item Perceived Stress Scale (Chronbach's alpha reliability = .82), which measures the degree to which situations in one's life are appraised as stressful. Each item is rated on a 0 (never) to 4 (very often) scale. Total possible scores range from 0 to 40, with higher scores indicating higher levels of general stress.

  41. Change from baseline in general perceived stress at 6 months [ Time Frame: Baseline and 6 months ]
    General stress is assessed with the 10-item Perceived Stress Scale (Chronbach's alpha reliability = .82), which measures the degree to which situations in one's life are appraised as stressful. Each item is rated on a 0 (never) to 4 (very often) scale. Total possible scores range from 0 to 40, with higher scores indicating higher levels of general stress.

  42. Change from baseline in general perceived stress at 12 months [ Time Frame: Baseline and 12 months ]
    General stress is assessed with the 10-item Perceived Stress Scale (Chronbach's alpha reliability = .82), which measures the degree to which situations in one's life are appraised as stressful. Each item is rated on a 0 (never) to 4 (very often) scale. Total possible scores range from 0 to 40, with higher scores indicating higher levels of general stress.

  43. Change from baseline in general perceived stress at 24 months [ Time Frame: Baseline and 24 months ]
    General stress is assessed with the 10-item Perceived Stress Scale (Chronbach's alpha reliability = .82), which measures the degree to which situations in one's life are appraised as stressful. Each item is rated on a 0 (never) to 4 (very often) scale. Total possible scores range from 0 to 40, with higher scores indicating higher levels of general stress.

  44. Change from baseline in sleep quantity and quality at 3 months [ Time Frame: Baseline and 3 months ]
    Sleep quantity and quality are measured with a sleep scale involving 9 items, designed as a Likert-type scale with each item measured on a 0 (not during the past month) to 3 (3 times during the past month). Eight items measure sleep problems and one item is a sleep quality rating (0=very good to 3=very bad). Total possible points range from 0 to 27, with higher scores indicating more sleep problems and poorer sleep quality.

  45. Change from baseline in sleep quantity and quality at 6 months [ Time Frame: Baseline and 6 months ]
    Sleep quantity and quality are measured with a sleep scale involving 9 items, designed as a Likert-type scale with each item measured on a 0 (not during the past month) to 3 (3 times during the past month). Eight items measure sleep problems and one item is a sleep quality rating (0=very good to 3=very bad). Total possible points range from 0 to 27, with higher scores indicating more sleep problems and poorer sleep quality.

  46. Change from baseline in sleep quantity and quality at 12 months [ Time Frame: Baseline and 12 months ]
    Sleep quantity and quality are measured with a sleep scale involving 9 items, designed as a Likert-type scale with each item measured on a 0 (not during the past month) to 3 (3 times during the past month). Eight items measure sleep problems and one item is a sleep quality rating (0=very good to 3=very bad). Total possible points range from 0 to 27, with higher scores indicating more sleep problems and poorer sleep quality.

  47. Change from baseline in spiritual coping at 3 months [ Time Frame: Baseline and 3 months ]
    Spiritual coping is measured with the Spiritual-Centered Coping subscale of the Africultural Coping Systems Inventory. Spiritual coping behaviors are grounded in the participant's perceived connection with the Creator or the Universe. The Likert-type contains 8 items, each ranging from 0 (did not use) to 3 (used a great deal). Total possible scores range from 0 to 24, with higher scores indicating higher levels of spiritual coping. Cronbach alpha reliability = .79.

  48. Change from baseline in spiritual coping at 6 months [ Time Frame: Baseline and 6 months ]
    Spiritual coping is measured with the Spiritual-Centered Coping subscale of the Africultural Coping Systems Inventory. Spiritual coping behaviors are grounded in the participant's perceived connection with the Creator or the Universe. The Likert-type contains 8 items, each ranging from 0 (did not use) to 3 (used a great deal). Total possible scores range from 0 to 24, with higher scores indicating higher levels of spiritual coping. Cronbach alpha reliability = .79.

  49. Change from baseline in spiritual coping at 12 months [ Time Frame: Baseline and 12 months ]
    Spiritual coping is measured with the Spiritual-Centered Coping subscale of the Africultural Coping Systems Inventory. Spiritual coping behaviors are grounded in the participant's perceived connection with the Creator or the Universe. The Likert-type contains 8 items, each ranging from 0 (did not use) to 3 (used a great deal). Total possible scores range from 0 to 24, with higher scores indicating higher levels of spiritual coping. Cronbach alpha reliability = .79.

  50. Change from baseline in self-efficacy at 3 months [ Time Frame: Baseline and 3 months ]
    Self-efficacy is measured with the Modified Generalized Self-Efficacy Scale, which measures how confident individuals are in managing their diabetes, despite life's stressors. The scale contains 10 Likert-type items rated from 0 (not true at all) to 4 (true nearly all of the time). Total scores range from 0 to 40, with higher scores indicating higher self-efficacy (Cronbach's alpha reliability = .76 - .90).

  51. Change from baseline in self-efficacy at 6 months [ Time Frame: Baseline and 6 months ]
    Self-efficacy is measured with the Modified Generalized Self-Efficacy Scale, which measures how confident individuals are in managing their diabetes, despite life's stressors. The scale contains 10 Likert-type items rated from 0 (not true at all) to 4 (true nearly all of the time). Total scores range from 0 to 40, with higher scores indicating higher self-efficacy (Cronbach's alpha reliability = .76 - .90).

  52. Change from baseline in self-efficacy at 12 months [ Time Frame: Baseline and 12 months ]
    Self-efficacy is measured with the Modified Generalized Self-Efficacy Scale, which measures how confident individuals are in managing their diabetes, despite life's stressors. The scale contains 10 Likert-type items rated from 0 (not true at all) to 4 (true nearly all of the time). Total scores range from 0 to 40, with higher scores indicating higher self-efficacy (Cronbach's alpha reliability = .76 - .90).

  53. Change from baseline in finding positive meaning at 3 months [ Time Frame: Baseline and 3 months ]
    The Positive Meaning Scale is used to measure the extent to which individuals find positive meaning in the context of having a diagnosis of type 2 diabetes. The scale contains 5 Likert-type items rated from 0 (definitely no) to 3 (definitely yes). Total scores range from 0 to 15, with higher scores indicating higher levels of finding positive meaning (Cronbach's alpha reliability = .73).

  54. Change from baseline in finding positive meaning at 6 months [ Time Frame: Baseline and 6 months ]
    The Positive Meaning Scale is used to measure the extent to which individuals find positive meaning in the context of having a diagnosis of type 2 diabetes. The scale contains 5 Likert-type items rated from 0 (definitely no) to 3 (definitely yes). Total scores range from 0 to 15, with higher scores indicating higher levels of finding positive meaning (Cronbach's alpha reliability = .73).

  55. Change from baseline in finding positive meaning at 12 months [ Time Frame: Baseline and 12 months ]
    The Positive Meaning Scale is used to measure the extent to which individuals find positive meaning in the context of having a diagnosis of type 2 diabetes. The scale contains 5 Likert-type items rated from 0 (definitely no) to 3 (definitely yes). Total scores range from 0 to 15, with higher scores indicating higher levels of finding positive meaning (Cronbach's alpha reliability = .73).

  56. Change from baseline in adaptive coping strategies at 3 months [ Time Frame: Baseline and 3 months ]
    The Coping Orientations to Problems Experienced Scale (Brief COPE, 14 adaptive coping items) is used to measure cognitive and behavioral strategies that enable an individual to handle adversity. The Brief COPE is a Likert-type scale in which participants rate on a 0 (I haven't been doing this AT ALL) to 3 (I've been doing this A LOT) scale. Total scores range from 0 to 42, with higher scores indicating higher levels of adaptive coping (Cronbach's alpha reliability = .73 - .79).

  57. Change from baseline in adaptive coping strategies at 6 months [ Time Frame: Baseline and 6 months ]
    The Coping Orientations to Problems Experienced Scale (Brief COPE, 14 adaptive coping items) is used to measure cognitive and behavioral strategies that enable an individual to handle adversity. The Brief COPE is a Likert-type scale in which participants rate on a 0 (I haven't been doing this AT ALL) to 3 (I've been doing this A LOT) scale. Total scores range from 0 to 42, with higher scores indicating higher levels of adaptive coping (Cronbach's alpha reliability = .73 - .79).

  58. Change from baseline in adaptive coping strategies at 12 months [ Time Frame: Baseline and 12 months ]
    The Coping Orientations to Problems Experienced Scale (Brief COPE, 14 adaptive coping items) is used to measure cognitive and behavioral strategies that enable an individual to handle adversity. The Brief COPE is a Likert-type scale in which participants rate on a 0 (I haven't been doing this AT ALL) to 3 (I've been doing this A LOT) scale. Total scores range from 0 to 42, with higher scores indicating higher levels of adaptive coping (Cronbach's alpha reliability = .73 - .79).

  59. Change from baseline in adaptation to stress at 3 months [ Time Frame: Baseline and 3 months ]
    The Connor-Davidson Resilience Scale is used to identify personal qualities that enable an individual to persevere and adapt positively in the face of adversity. The scale is a Likert-type instrument that contains 10 items, each of which is rated on a 1 (not at all true) to 4 (exactly true) scale. Total scores range from 10 to 40, with higher scores indicating higher levels of adaptation to stress (Cronbach's alpha reliability = .85). For confirmatory purposes, we also use the Brief Resilience Scale contains 6 items that also assess adaptation to stress, with a rating scale of 1 (strongly disagree) to 5 (strongly agree).

  60. Change from baseline in adaptation to stress at 6 months [ Time Frame: Baseline and 6 months ]
    The Connor-Davidson Resilience Scale is used to identify personal qualities that enable an individual to persevere and adapt positively in the face of adversity. The scale is a Likert-type instrument that contains 10 items, each of which is rated on a 1 (not at all true) to 4 (exactly true) scale. Total scores range from 10 to 40, with higher scores indicating higher levels of adaptation to stress (Cronbach's alpha reliability = .85). For confirmatory purposes, we also use the Brief Resilience Scale contains 6 items that also assess adaptation to stress, with a rating scale of 1 (strongly disagree) to 5 (strongly agree).

  61. Change from baseline in adaptation to stress at 12 months [ Time Frame: Baseline and 12 months ]
    The Connor-Davidson Resilience Scale is used to identify personal qualities that enable an individual to persevere and adapt positively in the face of adversity. The scale is a Likert-type instrument that contains 10 items, each of which is rated on a 1 (not at all true) to 4 (exactly true) scale. Total scores range from 10 to 40, with higher scores indicating higher levels of adaptation to stress (Cronbach's alpha reliability = .85). For confirmatory purposes, we also use the Brief Resilience Scale contains 6 items that also assess adaptation to stress, with a rating scale of 1 (strongly disagree) to 5 (strongly agree).

  62. Change from baseline in coping with discrimination at 3 months [ Time Frame: Baseline and 3 months ]
    The Coping with Discrimination Scale is used to determine how minority individuals respond to discrimination. We use 22 Likert-type items from the original 25-item scale, each of which is rated from 1 (never like me) to 6 (always like me). Total scores range from 22 - 132; higher scores indicate higher levels of coping. Scale reliability (Cronbach's alpha) ranges from .73 - .90.

  63. Change from baseline in coping with discrimination at 6 months [ Time Frame: Baseline and 6 months ]
    The Coping with Discrimination Scale is used to determine how minority individuals respond to discrimination. We use 22 Likert-type items from the original 25-item scale, each of which is rated from 1 (never like me) to 6 (always like me). Total scores range from 22 - 132; higher scores indicate higher levels of coping. Scale reliability (Cronbach's alpha) ranges from .73 - .90.

  64. Change from baseline in coping with discrimination at 12 months [ Time Frame: Baseline and 12 months ]
    The Coping with Discrimination Scale is used to determine how minority individuals respond to discrimination. We use 22 Likert-type items from the original 25-item scale, each of which is rated from 1 (never like me) to 6 (always like me). Total scores range from 22 - 132; higher scores indicate higher levels of coping. Scale reliability (Cronbach's alpha) ranges from .73 - .90.

  65. Change from baseline in emotional regulation at 3 months [ Time Frame: Baseline and 3 months ]
    The Brief Version of the Emotional Regulation Scale (DERS-16) is used to measure awareness and acceptance of emotions, as well as strategies used to regulate emotions. The scale consists of 16 Likert-type items with possible responses to each item ranging from 1 (almost never) to 5 (almost always). Total possible scores range from 16 to 80, with higher scores indicating less effective strategies used to regulate emotions. Scale reliability (Cronbach's alpha) ranges from 0.85 to 0.88.

  66. Change from baseline in emotional regulation at 6 months [ Time Frame: Baseline and 6 months ]
    The Brief Version of the Emotional Regulation Scale (DERS-16) is used to measure awareness and acceptance of emotions, as well as strategies used to regulate emotions. The scale consists of 16 Likert-type items with possible responses to each item ranging from 1 (almost never) to 5 (almost always). Total possible scores range from 16 to 80, with higher scores indicating less effective strategies used to regulate emotions. Scale reliability (Cronbach's alpha) ranges from 0.85 to 0.88.

  67. Change from baseline in emotional regulation at 12 months [ Time Frame: Baseline and 12 months ]
    The Brief Version of the Emotional Regulation Scale (DERS-16) is used to measure awareness and acceptance of emotions, as well as strategies used to regulate emotions. The scale consists of 16 Likert-type items with possible responses to each item ranging from 1 (almost never) to 5 (almost always). Total possible scores range from 16 to 80, with higher scores indicating less effective strategies used to regulate emotions. Scale reliability (Cronbach's alpha) ranges from 0.85 to 0.88.

  68. Change from baseline in social support at 3 months [ Time Frame: Baseline and 3 months ]
    The Multi-Dimensional Scale of Perceived Social Support is used to measure an individual's perceived adequacy of support for diabetes self-management from family, friends, and significant others. The instrument consists of 12 Likert-type items and each item is rated on a 1 (very strongly disagree) to 7 (very strongly agree) scale. Total possible scores range from 12 to 84, with higher scores indicating higher levels of perceived social support. Scale reliability (Chronbach's alpha) ranges from .84 to .92.

  69. Change from baseline in social support at 6 months [ Time Frame: Baseline and 6 months ]
    The Multi-Dimensional Scale of Perceived Social Support is used to measure an individual's perceived adequacy of support for diabetes self-management from family, friends, and significant others. The instrument consists of 12 Likert-type items and each item is rated on a 1 (very strongly disagree) to 7 (very strongly agree) scale. Total possible scores range from 12 to 84, with higher scores indicating higher levels of perceived social support. Scale reliability (Chronbach's alpha) ranges from .84 to .92.

  70. Change from baseline in social support at 12 months [ Time Frame: Baseline and 12 months ]
    The Multi-Dimensional Scale of Perceived Social Support is used to measure an individual's perceived adequacy of support for diabetes self-management from family, friends, and significant others. The instrument consists of 12 Likert-type items and each item is rated on a 1 (very strongly disagree) to 7 (very strongly agree) scale. Total possible scores range from 12 to 84, with higher scores indicating higher levels of perceived social support. Scale reliability (Chronbach's alpha) ranges from .84 to .92.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Participants must:

  • be African American;
  • be diagnosed with T2DM;
  • be 18 years of age or older;
  • not have participated in our previous intervention studies; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282395


Contacts
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Contact: Marco Buentello, MA 512-232-3851 marcobuentello@austin.utexas.edu
Contact: Courtney Swaney 512 471 6424 c_frazier@austin.utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Mary A. Steinhardt, EdD    512-232-3535    msteinhardt@austin.utexas.edu   
Contact: Joanne Delk    512 232 5486    joanne.delk@austin.utexas.edu   
Principal Investigator: Mary A. Steinhardt, EdD         
Principal Investigator: Sharon A. Brown, PhD         
Sponsors and Collaborators
University of Texas at Austin
University of Colorado, Denver
Investigators
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Principal Investigator: Mary A. Steinhardt, EdD University of Texas at Austin
Principal Investigator: Sharon A. Brown, PhD University of Texas at Austin
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Responsible Party: Mary Steinhardt, Principal Investigator (MPI), University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04282395    
Other Study ID Numbers: R01DK123146 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Steinhardt, University of Texas at Austin:
Self-management
Church setting
African Americans
Health disparities
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases