OBJECTIVE—To evaluate barriers to and strategies for medication adherence and predictors of adherence and the primary outcome in the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS—Within a randomized, controlled primary prevention study for type 2 diabetes, we collected data on study medication adherence, its predictors, and health outcomes in 27 clinical centers across mainland U.S. and Hawaii. Medication arm participants included 2,155 adults with impaired glucose tolerance randomly assigned to either metformin or matched placebo treatment arms. Structured interviews were used to promote medication adherence and to collect data regarding adherence. Adherence was measured by pill count. The primary DPP outcome of type 2 diabetes was assessed by fasting plasma glucose and oral glucose tolerance test. RESULTS—Older age-groups were more adherent than the youngest group (P = 0.01) in the metformin group. The most frequently reported barrier to adherence was “forgetting” (22%). Women reported more adverse effects of metformin (15 vs. 10%, P = 0.002) in the metformin group. Odds of nonadherence increased as participants reported more than one barrier (odds ratio 19.1, P < 0.001). Odds of adherence increased as participants reported multiple strategies to take medication (2.69, P < 0.0001). There was a 38.2% risk reduction for developing diabetes for those adherent to metformin compared with those adherent to placebo (P < 0.0003). CONCLUSIONS—DPP medication adherence results are unique in primary prevention for a chronic disease in a large multiethnic sample. Our finding that adherence was associated with risk reduction for diabetes supports the development of brief interventions in clinical settings where medication adherence is a challenge.
About 75% of African Americans (AAs) ages 20 or older are overweight and nearly 50% are obese, but community-based programs to reduce diabetes risk in AAs are rare. Our objective was to reduce weight and fasting plasma glucose (FPG) and increase physical activity (PA) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul (FBAS). We conducted a single-blinded, cluster randomized, community trial in 20 AA churches enrolling 604 AAs, aged 20 to 64 years with BMI ≥ 25 kg/m2 and without diabetes. The church (and their parishioners) was randomized to FBAS or health education (HE). FBAS participants had a significant difference in adjusted weight loss compared with those in HE (2.62 kg vs. 0.50 kg, p=0.001) at 12-weeks and (2.39 kg vs. −0.465 kg, p=0.005) at 12-months and were more likely (13%) than HE participants (3%) to achieve a 7% weight loss (p<0.001) at 12-weeks and a 7% weight loss (19% vs. 8%, p<0.001) at 12-months. There were no significant differences in FPG and PA between arms. Of the 15.2% of participants with baseline pre-diabetes, those in FBAS had, however, a significant decline in FPG (10.93 mg/dl) at 12-weeks compared with the 4.22 mg/dl increase in HE (p=0.017), and these differences became larger at 12-months (FBAS, 12.38 mg/dl decrease; HE, 4.44 mg/dl increase)(p=0.021). Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants.
Objective To determine if an evidence-based, behavioral lifestyle intervention program delivered at a worksite setting is effective in improving type 2 diabetes and CVD risk factors. Methods A randomized six-month delayed control design was utilized, with two-thirds of the participants assigned to begin intervention immediately and one-third beginning six months later. The year-long program (weekly for 3 months transitioning to monthly) focused on weight loss and increasing physical activity. Results The immediate intervention group had greater mean weight loss (−10.4 lbs., 5.1%, vs. −2.3 lbs., 1%, p=0.0001) than the delayed control group at 6 months and relatively greater improvements in activity, HbA1c and other risk factors. The delayed group experienced similar improvements after completing the intervention program. Conclusions A worksite behavioral lifestyle intervention is feasible and effective in significantly improving risk factors for diabetes and CVD.
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