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A randomized controlled trial of weight reduction and exercise for diabetes management in older African-American subjects
Agurs-Collins TD, Kumanyika SK, Ten Have TR, Adams-Campbell LL
Diabetes Care 1997 Oct;20(10):1503-1511
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate a weight loss and exercise program designed to improve diabetes management in older African-Americans. RESEARCH DESIGN AND METHODS: Overweight African-Americans (n = 64) ages 55 to 79 years with NIDDM were randomized to either an intervention (12 weekly group sessions, 1 individual session, and 6 biweekly group sessions) or usual care (1 class and 2 informational mailings). Clinical and behavioral variables were assessed at 0, 3, and 6 months of treatment. RESULTS: Significant net differences in the intervention versus usual care were observed for weight (-2.0 kg, p = 0.006), physical activity, and dietary intake of fat, saturated fat, cholesterol, and nutrition knowledge at 3 months (all p < 0.05) and for weight at 6 months (-2.4 kg; p = 0.006) and mean HbA1c values at 3 and 6 months (respectively, -1.6 and -2.4%, both p < 0.01). After the adjustment for changes in weight and activity, the intervention participants were approximately twice as likely to have a one unit decrease in HbA1c value as those in usual care. Blood pressure increases in usual care participants resulted in net differences (intervention minus control) at 3 and 6 months of -3.3 (p = 0.09) and -4.0 (p = 0.05) mmHg diastolic, respectively, and -8.4 (p = 0.06) and -5.9 (p > 0.10) mmHg systolic, respectively. Blood lipid profiles improved more in intervention than usual care participants, but not significantly. CONCLUSIONS: The intervention program was effective in improving glycemic and blood pressure control. The decrease in HbA1c values was generally independent of the relatively modest changes in dietary intake, weight, and activity and may reflect indirect program effects on other aspects of self-care.
Copyright American Diabetes Association. Reprinted with permission from The American Diabetes Association.

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