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A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity
Keyserling TC, Samuel-Hodge CD, Ammerman AS, Ainsworth BE, Henriquez-Roldan CF, Elasy TA, Skelly AH, Johnston LF, Bangdiwala SI
Diabetes Care 2002 Sep;25(9):1576-1583
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; 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 determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity (PA). RESEARCH DESIGN AND METHODS: In this randomized controlled trial conducted at seven practices in central North Carolina, 200 African-American women, >= 40 years of age with type 2 diabetes, were randomized to one of three treatment conditions: clinic and community (group A), clinic only (group B), or minimal intervention (group C). The clinic-based intervention (groups A and B) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practices and attitudes; the community-based intervention (group A) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was designed to provide social support and reinforce behavior change goals; and the minimal intervention (group C) consisted of educational pamphlets mailed to participants. The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer, which was worn while awake for 7 days. RESULTS: Totals of 175 (88%) and 167 (84%) participants completed PA assessment at 6 and 12 months, respectively. For comparison of PA, the p value for overall group effect was 0.014. Comparing group A with C, the difference in the average adjusted mean for PA was 44.1 kcal/day (95% CI 13.1 to 75.1, p = 0.0055). Comparing group B with C, the difference in the average adjusted mean was 33.1 kcal/day (95% CI 3.3 to 62.8, p = 0.029). The intervention was acceptable to participants: 88% were very satisfied with clinic-based counseling to enhance PA, and 86% indicated that the peer counselor's role in the program was important. CONCLUSIONS: The intervention was associated with a modest enhancement of PA and was acceptable to participants.
Copyright American Diabetes Association. Reprinted with permission from The American Diabetes Association.

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