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, Ն40 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 13.1-75.1, P ϭ 0.0055). Comparing group B with C, the difference in the average adjusted mean was 33.1 kcal/day (95% CI 3.3-62.8, P ϭ 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.
IMPORTANCE Most primary care clinicians lack the skills and resources to offer effective lifestyle and medication (L&M) counseling to reduce coronary heart disease (CHD) risk. Thus, effective and feasible CHD prevention programs are needed for typical practice settings.OBJECTIVE To assess the effectiveness, acceptability, and cost-effectiveness of a combined L&M intervention to reduce CHD risk offered in counselor-delivered and web-based formats.
DESIGN, SETTING, AND PARTICIPANTSA comparative effectiveness trial in 5 diverse family medicine practices in North Carolina. Participants were established patients, aged 35 to 79 years, with no known cardiovascular disease, and at moderate to high risk for CHD (10-year Framingham Risk Score [FRS], Ն10%).INTERVENTIONS Participants were randomized to counselor-delivered or web-based format, each including 4 intensive and 3 maintenance sessions. After randomization, both formats used a web-based decision aid showing potential CHD risk reduction associated with L&M risk-reducing strategies. Participants chose the risk-reducing strategies they wished to follow.
MAIN OUTCOMES AND MEASURESThe primary outcome was within-group change in FRS at 4-month follow-up. Other measures included standardized assessments of blood pressure, blood lipid levels, lifestyle behaviors, and medication adherence. Acceptability and cost-effectiveness were also assessed. Outcomes were assessed at 4 and 12 months.
RESULTSOf 2274 screened patients, 385 were randomized (192 counselor; 193 web): mean age, 62 years; 24% African American; and mean FRS, 16.9%. Follow-up at 4 and 12 months included 91% and 87% of the randomized participants, respectively. There was a sustained reduction in FRS at both 4 months (primary outcome) and 12 months for both counselor-based
Low‐income women in the United States have the highest rates of obesity, yet they are seldom included in weight loss trials. To address this research gap, components of two evidence‐based weight loss interventions were adapted to create a 16‐week intervention for low‐income women (Weight Wise Program), which was evaluated in a randomized trial with the primary outcome of weight loss at 5‐month follow‐up. Participants were low‐income women (40–64 years) with a BMI of 25–45. Of 143 participants, 72 were randomized to the Weight Wise Program (WWP) and 71 to the Control Group (CG). Five‐month follow‐up data were obtained from 64 (89%) WWP and 62 (87%) CG participants. With baseline values carried forward for missing data, WWP participants had a weight change of −3.7 kg compared to 0.7 kg in the CG (4.4 kg difference, 95% confidence interval (CI), 3.2–5.5, P < 0.001). For systolic blood pressure (SBP), change in the WWP was −6.5 mm Hg compared to −0.4 mm Hg among controls (6.2 mm Hg difference, 95% CI, 1.7–10.6, P = 0.007); for diastolic BP (DBP), changes were −4.1 mm Hg for WWP compared to −1.3 mm Hg for controls (2.8 mm Hg difference, 95% CI, 0.0–5.5, P = 0.05). Of the 72 WWP participants, 64, 47, and 19% lost at least 3, 5, and 7% of their initial body weight, respectively. In conclusion, the WWP was associated with statistically significant and clinically important short‐term weight loss.
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