Kerry Littlewood

EMPOWER: A randomized trial using community health workers to deliver a lifestyle intervention program in African American women with Type 2 diabetes: Design, rationale, and baseline characteristics☆

BACKGROUND African American (AA) women with Type 2 diabetes mellitus (T2DM) in the rural south experience less weight loss and poorer glycemic control in traditional diabetes management programs compared to Caucasians. This paper describes the design, rationale, and baseline characteristics from an innovative community health worker (CHW) delivered intervention program in this population. METHODS/DESIGN This prospective trial randomized rural AA women with uncontrolled T2DM (HbA1c ≥ 7.0) to receive a behaviorally-centered, culturally-tailored lifestyle intervention during 16 contacts from a trained AA CHW or 16 approved diabetes educational mailings. Changes from baseline in glycosylated hemoglobin levels (HbA1c), blood pressure (BP), weight, body mass index (BMI), self-reported dietary and physical activity patterns, and psychosocial measures including diabetes distress, empowerment, depression, self-care, medication adherence, and life satisfaction will be assessed at 6- and 12-months. BASELINE RESULTS Two hundred AA women (mean age = 53.09 ± 10.89 years) with T2DM from impoverished rural communities were enrolled. Baseline data demonstrated profoundly uncontrolled diabetes of long term duration (mean HbA1c = 9.11 ± 1.82; mean BMI = 37.68 ± 8.20; mean BP = 134.51 ± 20.39/84.19 ± 11.68; 10.5 ± 0.7 years). Self-care behavior assessment revealed poor dietary and medication adherence and sedentary lifestyle. Most psychosocial measures ranged within normal limits. CONCLUSION The present sample of AA women from impoverished rural communities exhibited significantly uncontrolled T2DM of long duration with associated obesity and poor lifestyle behaviors. An innovative CHW led lifestyle intervention may lead to more effective strategies for T2DM management in this population.

Regimen-Related Distress, Medication Adherence, and Glycemic Control in Rural African American Women With Type 2 Diabetes Mellitus

Background: Regimen-related emotional distress in patients with type 2 diabetes mellitus (T2DM) is associated with poor glycemic control, but the mediators of this relationship are not well described. Objective: This cross-sectional study at baseline examines these relationships, including the specific role of medication adherence in rural African American women. Methods: At baseline in the EMPOWER randomized trial, the investigators collected the following data: Regimen-Related Distress (RRD; subscale of the validated Diabetes Distress Scale), diabetes medications, medication adherence using the Morisky Medication Adherence Scale, and hemoglobin A1C (A1C). Results: The study enrolled 189 rural African American women with T2DM (mean age = 53 ± 11 years, A1C = 9.1% ± 1.8%, body mass index = 37.7% ± 8.2%; 61% on insulin); 56% reported elevated RRD (mean ≥ 3.0), and this was associated with significantly lower medication adherence (4.4 vs 6.4, P < 0.001) and significantly higher A1C (9.5% vs 8.6%, P < 0.001). In multivariate modeling, both elevated RRD (exp β = 2.1; 95% CI = 1.1-4.2; P < 0.05) and lower medication adherence (exp β = 3.3; 95% CI = 1.1-9.6; P < 0.05) were independently associated with higher A1C values. In mediation analysis, medication adherence was a significant mediator of the effects of RRD on A1C. Conclusion: Among rural African American women with T2DM, elevated levels of RRD were common and were associated with higher A1C values, in part via effects on medication adherence. Complex treatment regimens accompanied by psychological distress may be associated with poorer glycemic control.

COMRADE: A randomized trial of an individually tailored integrated care intervention for uncontrolled type 2 diabetes with depression and/or distress in the rural southeastern US

BACKGROUND Emerging evidence suggests that people living with Type 2 diabetes mellitus (T2D) are also at greater risk for depression and distress. If left untreated, these comorbid mental health concerns can have long-lasting impacts on medical and physical health outcomes. DESIGN This prospective trial randomized rural men and women with uncontrolled T2D (HbA1c ≥ 7.0) who screened positive for co-morbid depressive (PHQ-2 > 3) or distress (DDS-2 > 3) symptoms in a primary medical care setting to receive either: 1) 16 sessions of cognitive and/or behavioral intervention tailored to symptom severity across 12 months along with routine medical care, or 2) usual primary care. Outcomes included change from baseline to 12-months in HbA1c, diabetes related distress, depressive symptoms, and diabetes self-care activities. BASELINE RESULTS 139 patients (Mean age = 52.6 ± 9.6 years) with T2D from impoverished rural communities were enrolled (almost half reporting annual income of <

Kin as Teachers: An early childhood education and support intervention for kinship families

10,000 per year). Baseline data indicated that patients were experiencing profoundly uncontrolled T2D of a long duration (Mean HbA1c = 9.61 ± 2.0; Mean BMI = 37.0 ± 9.1; Mean duration = 11.2 ± 8.9 years) along with high levels of distress (Mean DDS-17 Scale Score = 2.5 ± 1.0) and/or depressive symptoms (Mean PHQ-9 Scale Score = 9.3 ± 6.1). CONCLUSION Patients with uncontrolled T2D of long duration manifest complex co-morbidities including associated obesity, depressive symptoms and/or diabetes related distress. A behavioral intervention for T2D that concurrently targets symptoms of depression and distress may lead to more effective outcomes in this high-risk population. CLINICAL TRIAL REGISTRATION NCT02863523.