title: Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  Self-referred, community-dwelling adults with type 2 diabetes mellitus.
  
  
  METHODS
  The intervention group received Social Cognitive Theory-based counseling paired with technology-based self-monitoring, and results were compared with an attention control group.
  
  
  METHODS
  Glycated hemoglobin, fasting serum glucose, lipid levels, blood pressure, weight, body mass index, and waist circumference were evaluated.
  
  
  METHODS
  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.
authors: Pittsburgh Healthcare System and the School of Medicine, University of Pittsburgh,230 McKee Pl, Pittsburgh, PA 15213, USA. sevick@pitt.edu
authors: Mary Ann
authors: MA
authors: Sevick
authors: Mary
authors: M
authors: Korytkowski
authors: Roslyn A
authors: RA
authors: Stone
authors: Beth
authors: B
authors: Piraino
authors: Dianxu
authors: D
authors: Ren
authors: Susan
authors: S
authors: Sereika
authors: Yuanyuan
authors: Y
authors: Wang
authors: Ann
authors: A
authors: Steenkiste
authors: Lora E
authors: LE
authors: Burke
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000097:blood / Q000628:therapy; D015928:Cognitive Behavioral Therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000628:therapy*; D003928:Diabetic Nephropathies / Q000097:blood / Q000628:therapy; D005260:Female; D005919:Glomerular Filtration Rate; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010353:Patient Education as Topic; D012648:Self Care; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D008055:Lipids