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Biophysiologic Outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) Trial

UNSPECIFIED (2012) Biophysiologic Outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) Trial. Journal of the Academy of Nutrition and Dietetics, 112 (8). 1147 - 1157. ISSN 2212-2672

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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. © 2012 Academy of Nutrition and Dietetics.


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Details

Item Type: Article
Status: Published
Date: 1 August 2012
Date Type: Publication
Journal or Publication Title: Journal of the Academy of Nutrition and Dietetics
Volume: 112
Number: 8
Page Range: 1147 - 1157
DOI or Unique Handle: 10.1016/j.jand.2012.05.008
Schools and Programs: School of Nursing > Nursing
Refereed: Yes
ISSN: 2212-2672
Other ID: NLM NIHMS396721, NLM PMC3436596
PubMed Central ID: PMC3436596
PubMed ID: 22818724
Date Deposited: 20 Sep 2012 21:11
Last Modified: 06 Jan 2019 02:55
URI: http://d-scholarship.pitt.edu/id/eprint/14295

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