Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial.

Sevick MA, Korytkowski M, Stone RA, Piraino B, Ren D, Sereika S, Wang Y, Steenkiste A, Burke LE. Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial. Journal of the Academy of Nutrition and Dietetics. 2012 Aug 1; 112(8):1147-57.

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Abstract:

BACKGROUND: Behavioral research to improve lifestyle in broadly defined populations of patients with type 2 diabetes is limited. OBJECTIVE: We evaluated a behavioral intervention featuring technology-based self-monitoring on biophysiologic outcomes of glycemic control and markers of cardiovascular risk. DESIGN: In this single-site, randomized clinical trial, participants were stratified by good and poor glycemic control (glycated hemoglobin < 8% or = 8%) and absence or presence of kidney disease, (estimated glomerular filtration rate = 60 or < 60 mL/min) and randomized within strata. Measurements were obtained at 0, 3, and 6 months. PARTICIPANTS/SETTING: Self-referred, community-dwelling adults with type 2 diabetes mellitus. INTERVENTION: The intervention group received Social Cognitive Theory-based counseling paired with technology-based self-monitoring, and results were compared with an attention control group. MAIN OUTCOME MEASURES: Glycated hemoglobin, fasting serum glucose, lipid levels, blood pressure, weight, body mass index, and waist circumference were evaluated. STATISTICAL ANALYSES PERFORMED: Mean differences within and between randomization groups were compared over time. Intervention effects over time were estimated using random intercept models. RESULTS: Two hundred ninety-six subjects were randomized, 256 (86.5%) completed 3-month and 246 (83.1%) completed 6-month assessments. Glycated hemoglobin was reduced in the intervention group by 0.5% at 3 months and 0.6% at 6 months (P < 0.001 for each), and the control group by 0.3% (P < 0.001) at 3 months and 0.2% (P < 0.05) at 6 months; but between-group differences were not significant. In those with baseline glycated hemoglobin = 8% and estimated glomerular filtration rate = 60 mL/min, glycated hemoglobin was reduced in the intervention group by 1.5% at 3 months and 1.8% at 6 months (P < 0.001 for each), and the control group by 0.9% (P < 0.001) at 3 months and 0.8% (P < 0.05) at 6 months; but between-group differences were not significant. In random intercept models, the estimated reduction in glycated hemoglobin of 0.29% was not significant. CONCLUSIONS: Two behavioral approaches to improving general lifestyle management in individuals with type 2 diabetes mellitus were effective in improving glycemic control, but no significant between-group differences were observed.