Larry F. Johnston

A Randomized Trial of a Church-Based Diabetes Self-management Program for African Americans With Type 2 Diabetes

Purpose This study developed and tested a culturally appropriate, church-based intervention to improve diabetes self-management. Research Design and Methods This was a randomized trial conducted at 24 African American churches in central North Carolina. Churches were randomized to receive the special intervention (SI; 13 churches, 117 participants) or the minimal intervention (MI; 11 churches, 84 participants). The SI included an 8-month intensive phase, consisting of 1 individual counseling visit, 12 group sessions, monthly phone contacts, and 3 encouragement postcards, followed by a 4-month reinforcement phase including monthly phone contacts. The MI received standard educational pamphlets by mail. Outcomes were assessed at 8 and 12 months; the primary outcome was comparison of 8-month A1C levels. Results At baseline, the mean age was 59 years, A1C 7.8%, and body mass index 35.0 kg/m2; 64% of participants were female. For the 174 (87%) participants returning for 8-month measures, mean A1C (adjusted for baseline and group randomization) was 7.4% for SI and 7.8% for MI, with a difference of 0.4% (95% confidence interval [CI], 0.1-0.6, P = .009). In a larger model adjusting for additional variables, the difference was 0.5% (95% CI, 0.2-0.7, P < .001). At 12 months, the difference between groups was not significant. Diabetes knowledge and diabetes-related quality of life significantly improved in the SI group compared with the MI group. Among SI participants completing an acceptability questionnaire, intervention components and materials were rated as highly acceptable. Conclusions The church-based intervention was well received by participants and improved short-term metabolic control.

A Diabetes Management Program for African American Women With Type 2 Diabetes

PURPOSE this paper describes a clinic and community-based diabetes intervention program designed to improve dietary, physical activity, and self-care behaviors of older African American women with type 2 diabetes. It also describes the study to evaluate this program and baseline characteristics of participants. METHODS The New Leaf... Choices for Healthy Living With Diabetes program consists of 4 clinic-based health counselor visits, a community intervention with 12 monthly phone calls from peer counselors, and 3 group sessions. A randomized, controlled trial to evaluate the effectiveness of this intervention is described. RESULTS Seventeen focus groups of African American women were used to assessed the cultural relevance/acceptability of the intervention and measurement instruments. For the randomized trial, 200 African American women with type 2 diabetes were recruited from 7 practices in central North Carolina. Mean age was 59, mean diabetes duration was 10 years, and participants were markedly overweight and physically inactive. CONCLUSIONS Participants found this program to be culturally relevant and acceptable. Its effects on diet, physical activity, and self-care behaviors will be assessed in a randomized trial.

Randomized trial of a behavioral weight loss intervention for low-income women: the Weight Wise Program.

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.

A Comparison of Live Counseling With a Web-Based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease Risk A Randomized Clinical Trial

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 PARTICIPANTS A 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], ≥10%). 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 MEASURES The 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. RESULTS Of 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 (-2.3% [95% CI, -3.0% to -1.6%] and -1.9% [95% CI, -2.8% to -1.1%], respectively) and web-based groups (-1.5% [95% CI, -2.2% to -0.9%] and -1.7% [95% CI, -2.6% to -0.8%] respectively). At 4 months, the adjusted difference in FRS between groups was -1.0% (95% CI, -1.8% to -0.1%) (P = .03), and at 12 months, it was -0.6% (95% CI, -1.7% to 0.5%) (P = .30). The 12-month costs from the payer perspective were

Rationale, design, and sample characteristics of a practical randomized trial to assess a weight loss intervention for low-income women: The Weight-Wise II Program

207 and

Cost-effectiveness of a behavioral weight loss intervention for low-income women: the Weight-Wise Program.

110 per person for the counselor- and web-based interventions, respectively. CONCLUSIONS AND RELEVANCE Both intervention formats reduced CHD risk through 12-month follow-up. The web format was less expensive. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01245686.

Translation of a behavioral weight loss intervention for mid-life, low-income women in local health departments

Obesity is common among low-income mid-life women, yet most published weight loss studies have not focused on this population and have been highly resourced efficacy trials. Thus, practical type 2 translational studies are needed to evaluate weight loss interventions for low-income women. In this paper, we present the rationale, study design, and baseline characteristics of a type 2 translational study that evaluates both the processes and outcomes of a weight loss intervention for low-income women given at 6 county health departments in North Carolina. Key features of this study include random selection of study sites, intervention delivery by current staff at study sites, efforts to integrate the intervention with local community resources, a focus on evaluating the processes of translation using the RE-AIM framework, use of an evidence-based weight loss intervention, a detailed description of participant recruitment and representativeness, and a practical randomized trial designed to assess the effectiveness of the intervention. Of 81 health departments invited to participate, 30 (37%) were eligible and willing, and 6 were selected at random to deliver the intervention. Of 432 potential participants screened by phone, 213 (49%) were eligible and of these, 189 (89%) completed baseline measures and were randomized to receive a 5-month weight loss intervention or a delayed intervention. The mean age was 51, mean BMI 37 kg/m(2), 53% were African American, and 43% had no health insurance. The results of this study should be informative to key stakeholders interested in real world weight loss interventions for low-income mid-life women.

Psychometric Properties of the Modified RESIDE Physical Activity Questionnaire among Low-Income Overweight Women

OBJECTIVE Assess the cost-effectiveness of a 16-week weight loss intervention (Weight-Wise) for low-income midlife women. METHOD A randomized controlled trial conducted in North Carolina in 2007 tested a weight loss intervention among 143 women (40-64 years old, mean BMI=35.1 kg/m(2)). Women were randomized to one of two arms-special intervention (n=72) and a wait-listed control group (n=71). Effectiveness measures included changes in weight, systolic and diastolic blood pressure, total cholesterol, and HDL cholesterol. Cost-effectiveness measures calculated life years gained (LYG) from changes in weight, based on excess years life lost (YLL) algorithm. RESULTS Intervention participants had statistically significant decreases in weight (kg) (-4.4 95% CI=-5.6, -3.2) and in systolic blood pressure (-6.2 mm Hg, 95% CI=-10.6, -1.7) compared to controls. Total cost of conducting Weight-Wise was

Development and Evaluation of a Brief Questionnaire to Assess Dietary Fat Quality in Low-income Overweight Women in the Southern United States

17,403, and the cost per participant in intervention group was

Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project

242. The incremental cost per life year gained (discounted) from a decrease in obesity was