COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, N.I.H., EXTRAMURAL
RESEARCH SUPPORT, U.S. GOV'T, P.H.S.
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Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial.

OBJECTIVE: The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes.

RESEARCH DESIGN AND METHODS: The study used a randomized controlled trial (RCT) pretest/post-test design with repeated measures. Patients were randomly assigned to either a six-week intervention group or a six-week wait-listed control group. After completing the six sessions, patients were invited to participate in one of two follow-up conditions; attend a monthly support group or receive a monthly phone call from a nurse. Assessment measures included HbA1C, lipids, blood pressure, weight, self-management behavior and psychosocial adaptation.

RESULTS: Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT. These gains were maintained or improved upon during the one-year follow-up period. For patients in the two follow-up conditions, a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values.

CONCLUSIONS: We believe that results of this study can be attributed to volunteer bias, study effects (ie, providing study data on several occasions to patients and their physicians during the one-year study period), and impact of the interventions. However, the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period.

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