• Contemp Clin Trials · Sep 2013

    Randomized Controlled Trial

    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.

    • Doyle M Cummings, Lesley D Lutes, Kerry Littlewood, Emily Dinatale, Bertha Hambidge, and Kathleen Schulman.
    • Department of Family Medicine, East Carolina University, Brody School of Medicine, Greenville, NC 27834, USA. cummingsd@ecu.edu
    • Contemp Clin Trials. 2013 Sep 1; 36 (1): 147-53.

    BackgroundAfrican 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/DesignThis 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 ResultsTwo 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.ConclusionThe 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.Copyright © 2013 Elsevier Inc. All rights reserved.

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