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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 wer

Background: The information processing demands associated with behavioral self-management of diabetes are extensive. Pairing personal digital assistant (PDA)-based self-monitoring with a behavioral self-management intervention may improve adherence and patient outcomes. Methods: ENHANCE is a randomized controlled trial to test an intervention designed to improve regimen adherence in adults with type 2 diabetes. The intervention, based on Social Cognitive Theory (SCT), is paired with PDA-based self-monitoring. In this paper we describe the: (a) manner in which PDA-based self-monitoring is integrated within the SCT-based intervention, (b) feasibility and acceptability of PDA-based dietary self-monitoring, and (c) issues encountered in teaching participants to self-monitor using a PDA. Results: During the first 30 months of this 5-year study, 232 participants were screened and 151 were randomized. To date, 6 cohorts have completed the study. The retention rate is 85% (n = 129). Of those randomized to the intervention (n = 74) and completing the study (n = 61), 88% reported understanding the usefulness of PDA-monitoring, 85% reported ease in entering foods into the device, 70% reported ease in interpreting feedback graphs, and 82% indicated that they would continue to use the PDA for self-monitoring after the study concluded. Assuming 3 meals per day, participants entered an average of 58% of their meals in their PDA, and 43% were entered assuming 4 meals per day. If we eliminate from the analysis those individuals who entered less than 10% of their expected meals (n = 12), the average rate of self-monitoring was 69% assuming 3 meals per day, and 52% assuming 4 meals per day. Conclusions: PDA-based dietary monitoring is perceived by participants to be useful and acceptable. The approach used to instruct participants in use of the PDA and lessons learned are discussed. PDA technology shows promise as a tool for assisting those with type 2 diabetes in their efforts to man

Specificity in the self-efficacy construct requires that instruments assess domain-specific behaviors. The objectives of the study were to (1) reexamine and shorten the original 57-item Cholesterol-Lowering Diet Self-Efficacy Scale (CLDSES), (2) estimate reliability and validity of the short form CLDSES (CLDSES-SF), (3) examine the dimensionality of the CLDSES-SF, (4) examine discriminant validity of the scale by its ability to differentiate between adherence and nonadherence to saturated fat intake guidelines, and (5) examine the CLDSES-SF's sensitivity and specificity. A sample of 238 patients being treated for hypercholesterolemia completed three instruments: the CLDSES, the Connor Diet Habit Survey (DHS) and a Three-Day Food Record. Internal consistency for the CLDSES-SF was .95. The inter-correlation coefficients among the seven sub-scales ranged from .28 to .62, and for the total to sub-scales .58 - .87, significant at p < .001. Evidence for criterion validity was shown in the correlations between the CLDSES-SF and the Connor DHS scores and between the CLDSES-SF and the Three-Day Food Record. Factor analysis showed a one-factor model that fits the data with a sufficient amount of total variance explained among the seven subscale items in each subscale, providing evidence of the uni-dimensionality of each subscale. Sensitivity (76%) and specificity (63%) for the CLDSES-SF were good with 88% positive predictive value for adherence. The shortened CLDSES retained its good psychometric properties and remains comprehensive in its assessment of self-efficacy for adherence to a cholesterol-lowering diet. © 2006 European Society of Cardiology.

Background: The treatment of obesity, marked by a high rate of recidivism, lacks strategies that sustain the improved lifestyle behaviors that led to the weight loss. Self-monitoring, a behavioral strategy to increase awareness of one's behavior, is the cornerstone of behavioral treatment in weight loss management. However, adherence to self-monitoring is less than ideal. The actual patterns of self-monitoring of eating behaviors in weight loss treatment programs have not been studied previously; if done, these data could provide information on how self-monitoring patterns affect weight loss and if interventions can be developed that address deficits in self-monitoring. Technology now permits an instrumented paper-and-pencil diary to record the real time of individuals' self-monitoring behaviors (invivodata, inc.), thus providing more information about self-reported behaviors. This technology differs from PDA based products (ex. e-diary, e-trials, logpad, PICS) because, to the user, it is no different from a standard paper-and-pencil diary. Methods: The purposes of this ancillary study are: (1) to describe the electronically recorded patterns of self-monitoring of eating behaviors by weight-loss study participants; (2) compare reported vs. electronically recorded self-monitoring; and (3) examine the relationship between the electronically validated adherence to self-monitoring goals and success in weight loss in a sub-sample of participants in the PREFER study. This paper describes the design, methods and preliminary 6-month results. Results: Preliminary results reveal that participants frequently report recording their eating behavior during times when the binder was not opened. Two examples of data are shown that demonstrate the lack of concordance between the self-reported and the electronically recorded data. Conclusions: These unobtrusively collected electronic data can lead to the development of strategies that can promote improved adherence to self-monitoring

Objective: The purpose of this study was to pilot test an intervention to enhance the adherence of study participants to the hemodialysis dietary regimen. Design: A single case study design was used to examine the potential effectiveness of the intervention over a 4-month period of time. Setting: A dialysis center in southwestern Pennsylvania. Patients: Of the five individuals entered into the study, one was male and four were female, four were black, and one was white. Participants were 63 to 70 years of age, and had been receiving dialysis for a median of 36 months (range, 18 to 84 months). Intervention: The intervention included counseling to enhance self-efficacy, by a renal dietitian, paired with personal digital assistant-based dietary self-monitoring. Participants met twice per week with interventionists during the first 6 weeks, weekly during the second 6-week period, and biweekly in the final 4-week period. Main outcome measures: Monthly laboratory data regarding serum albumin, potassium, and phosphorus levels; Kt/V; and data on average monthly interdialytic weight gain were abstracted from the participants' medical records. C-reactive protein level was determined at baseline and at 4 months. Results: Four of five study participants had an increase in serum albumin level from baseline to their final measurement, and one participant maintained a stable albumin level. Four of five participants also experienced a small increase in serum phosphorus level. Mixed results were obtained with regard to serum potassium and average monthly interdialytic weight gain. Conclusions: Because of the small sample and single case study design, caution must be used in drawing firm conclusions from this study. Data suggest that the intervention may result in improved dietary intake and improved serum albumin levels. With increased dietary intake, serum phosphorus levels may increase. Additional research is needed to determine the potential efficacy and cost-effectiveness of thi

This article reviews the literature on the use of paper diaries for self-monitoring food intake, identifies the strengths and limitations of paper-and-pencil diaries and their new counterpart, the electronic diary or personal digital assistant (PDA), and reports how participants were trained to use a PDA with dietary software in two pilot studies - one with hemodialysis patients and the other with participants in a weight loss study. The report of the pilot studies focuses on the practical issues encountered in training participants in the use of a PDA and addresses the pros and cons of different dietary software programs. Six hemodialysis patients were trained in the first study and seven participants attempting to lose or maintain their weight were trained in the second pilot study. The training focused on how to use a PDA and how to navigate the dietary software to self-monitor food intake. The goals of using the PDA were to improve adherence to the therapeutic diets and to self-monitoring. Lessons learned from the pilot studies are shared. © 2005 by the National Kidney Foundation, Inc.

Objective. To examine factors contributing to the loss of potential minority participants in a study of medication adherence among rheumatoid arthritis patients. Methods. Chi-square statistics were used to test for differences in refusal/ineligibility by race and site at 4 screening points (initial eligibility review, initial patient contact, adherence screening, and informed consent). Differences in criteria-specific risks for exclusion at initial eligibility review were examined across 4 sites by race. Odds ratios (95% confidence intervals) were estimated if differences were significant. Multivariate logistic regression was used to examine sociodemographic factors associated with the probability for ineligibility at the initial eligibility review. Stated reasons for refusal were qualitatively quantified. Results. A greater percentage of African Americans were lost at every screening point when compared with whites, but only the difference at the initial eligibility review was statistically significant. Conclusion. Factors associated with attrition included selection of area medical sites, research design issues, comorbid conditions, alcohol abuse, and being younger, unmarried, African American, and male.

A cornerstone of treatment for hypercholesterolemia is dietary therapy. However, maintaining adherence to the therapeutic diet has been difficult for patients. There is evidence that self-efficacy is a predictor of positive behavior change like that involved in or necessary for initiating or maintaining recommended diet therapy for cholesterol reduction. This paper reports on two studies guided by Bandura's self-efficacy theory. The first study focuses on development and initial psychometric evaluation of an instrument measuring self-efficacy for adhering to a cholesterol-lowering diet in a sample of 44 cardiac rehabilitation patients; the second establishes psychometric properties of the instrument in a sample of 228 subjects treated for hypercholesterolemia. In both studies, subgroups completed the instrument a second time to provide data on the instrument's temporal stability. The Cholesterol-Lowering Diet Self-Efficacy Scale consists of 33 statements, some with branches for a total of 56 items. The scale measures several components of the eating habits domain related to adhering to a cholesterol-lowering eating plan, and shows good reliability and validity. Reported self-efficacy is related to prior persistence and past success in modifying and maintaining dietary changes, and also to concurrent measures of dietary adherence behaviors. The scale is psychometrically sound thus far and seems adequate in identifying success in achieving and maintaining a cholesterol-lowering eating plan. © 2003 European Society of Cardiology. Published by Elsevier B.V. All rights reserved.

This study examined adherence to angiotensin-converting enzyme inhibitor therapy among 171 heart failure clinic patients. Adherence was monitored over a 3-month period with an electronic event monitor housed in a medication bottle cap, which recorded the date and time the cap was opened and closed. The average percentage of days that the prescribed number of doses (regimen adherence) was taken over the observation period was 84%. Seventy-one percent of patients showed 85%-100% adherence with their daily regimen; 19% exhibited less than 70% adherence. The overall high rates of adherence to angiotensin-converting enzyme inhibitor therapy observed among heart failure clinic patients is consistent with research that shows improved outcomes for patients managed in heart failure clinics. Electronic medication monitoring can be useful in identifying a substantial fraction of patients who are poorly adherent so that interventions to improve adherence can be targeted toward them. Additional research is needed to develop and test adherence-enhancing interventions. Copyright 2002 CHF, Inc.