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The effects of professional continuous glucose monitoring as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes.
Rivera-Ávila, DA, Esquivel-Lu, AI, Salazar-Lozano, CR, Jones, K, Doubova, SV
BMC endocrine disorders. 2021;(1):79
Abstract
BACKGROUND The study objective was to evaluate the effects of professional continuous glucose monitoring (CGM) as an adjuvant educational tool for improving glycemic control in patients with type 2 diabetes (T2D). METHODS We conducted a three-month quasi-experimental study with an intervention (IGr) and control group (CGr) and ex-ante and ex-post evaluations in one family medicine clinic in Mexico City. Participants were T2D patients with HbA1c > 8% attending a comprehensive diabetes care program. In addition to the program, the IGr wore a professional CGM sensor (iPro™2) during the first 7 days of the study. Following this period, IGr participants had a medical consultation for the CGM results and treatment adjustments. Additionally, they received an educational session and personalized diet plan from a dietitian. After 3 months, the IGr again wore the CGM sensor for 1 week. The primary outcome variable was HbA1c level measured at baseline and 3 months after the CGM intervention. We analyzed the effect of the intervention on HbA1c levels by estimating the differences-in-differences treatment effect (Diff-in-Diff). Additionally, baseline and three-month CGM and dietary information were recorded for the IGr and analyzed using the Student's paired t-test and mixed-effects generalized linear models to control for patients' baseline characteristics. RESULTS Overall, 302 T2D patients participated in the study (IGr, n = 150; control, n = 152). At the end of the three-month follow-up, we observed 0.439 mean HbA1C difference between groups (p = 0.004), with an additional decrease in HbA1c levels in the IGr compared with the CGr (Diff-in-Diff HbA1c mean of - 0.481% points, p = 0.023). Moreover, compared with the baseline, the three-month CGM patterns showed a significant increase in the percentage of time in glucose range (+ 7.25; p = 0.011); a reduction in the percentage of time above 180 mg/dl (- 6.01; p = 0.045), a decrease in glycemic variability (- 3.94, p = 0.034); and improvements in dietary patterns, shown by a reduction in total caloric intake (- 197.66 Kcal/day; p = 0.0001). CONCLUSION Professional CGM contributes to reducing HbA1c levels and is an adjuvant educational tool that can improve glycemic control in patients with T2D. TRIAL REGISTRATION ClinicalTrials.gov: NCT04667728 . Registered 16/12/2020.
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Effects of self-management programs on behavioral modification among individuals with chronic disease: A systematic review and meta-analysis of randomized trials.
Kim, S, Park, M, Song, R
PloS one. 2021;(7):e0254995
Abstract
The prevalence of chronic disease associated with unhealthy lifestyles has been increasing worldwide. Health professionals have recognized that self-management programs (SMPs) can provide health benefits by promoting health behaviors, especially when applied to individuals with lifestyle-related chronic disease. This review performed a meta-analysis of the features of SMPs using randomized studies and analyzed the magnitude of the combined effects of self-management on behavioral modification. We searched the PubMed, CINAHL, ScienceDirect, SCOPUS, Web of Science, Embase, Cochrane Library, DBpia, and KISS to identify randomized trials that evaluated the behavioral outcomes of SMPs. Subgroup analyses were performed for program duration, providers, type of comparisons, and program settings. We selected 25 studies (N = 5,681) to perform analyses with random-effects models. The effect sizes of SMPs were small but significant for physical activity (standardized difference in means [SDM] = 0.25), dietary habits (SDM = 0.28), and health responsibility (SDM = 0.18), and not significant for stress management and smoking behaviors. A short-term SMPs (less than 12 weeks) was indicated as being effective in modifying physical activity, dietary habits, and health responsibility, while the program effects on dietary habits were significant only with expert-delivered education and when compared with inactive controls. The findings of this study indicate that SMPs can effectively improve physical activity, dietary habits, and health responsibility in individuals with chronic disease, with a small but significant effect size. Future studies should explore the effects of SMPs on stress management and smoking cessation and assess the long-term maintenance of healthy lifestyles in individuals with lifestyle-related chronic disease.
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Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention.
Schumacher, LM, Martinelli, MK, Convertino, AD, Forman, EM, Butryn, ML
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2021;(2):103-111
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Abstract
BACKGROUND Self-monitoring is a key component of behavioral weight loss (BWL) interventions. Past research suggests that individuals may avoid self-monitoring in certain contexts (e.g., skipping self-weighing after higher-than-usual calorie intake). However, no studies have attempted to quantify individuals' inclination to avoid information about their weight control ("weight-related information avoidance"; WIA) or prospectively examined its implications for treatment engagement and outcomes in BWL programs. PURPOSE Characterize WIA using a validated questionnaire among adults enrolled in BWL treatment and examine whether WIA prospectively predicts self-monitoring adherence, session attendance, treatment discontinuation, or weight loss. METHODS Participants (N = 87; MBMI = 34.9 kg/m2, 83% female) completed a measure of WIA prior to starting a 12 week, group-based BWL intervention. Participants were given digital self-monitoring tools and instructed to self-monitor their food intake daily, physical activity daily, and body weight weekly (Weeks 1-10) and then daily (Weeks 11-12). Session attendance and treatment discontinuation were recorded. Weight was measured in-clinic pretreatment and posttreatment. RESULTS While mean WIA was low (M = 2.23, standard deviation [SD] = 0.95; potential scale range: 1-7), greater WIA predicted poorer attendance (r = -.23; p = .03) and poorer self-monitoring of physical activity (r = -.28; p = .009) and body weight (r = -.32; p = .003). WIA did not predict food monitoring (p = .08), treatment discontinuation (p = .09), or 12 week weight loss (p = .91). CONCLUSIONS Greater WIA, as assessed via a brief questionnaire, may place individuals at risk for poorer self-monitoring and treatment engagement during BWL. Further research on the implications of WIA in the context of weight management is warranted, including evaluation of correlates, moderators, and mechanisms of action of WIA. CLINICAL TRIAL REGISTRATION NCT03337139.
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Toward a Digital Platform for the Self-Management of Noncommunicable Disease: Systematic Review of Platform-Like Interventions.
Tighe, SA, Ball, K, Kensing, F, Kayser, L, Rawstorn, JC, Maddison, R
Journal of medical Internet research. 2020;(10):e16774
Abstract
BACKGROUND Digital interventions are effective for health behavior change, as they enable the self-management of chronic, noncommunicable diseases (NCDs). However, they often fail to facilitate the specific or current needs and preferences of the individual. A proposed alternative is a digital platform that hosts a suite of discrete, already existing digital health interventions. A platform architecture would allow users to explore a range of evidence-based solutions over time to optimize their self-management and health behavior change. OBJECTIVE This review aims to identify digital platform-like interventions and examine their potential for supporting self-management of NCDs and health behavior change. METHODS A literature search was conducted in January 2020 using EBSCOhost, PubMed, Scopus, and EMBASE. No digital platforms were identified, so criteria were broadened to include digital platform-like interventions. Eligible platform-like interventions offered a suite of discrete, evidence-based health behavior change features to optimize self-management of NCDs in an adult population and provided digitally supported guidance for the user toward the features best suited to their needs and preferences. Data collected on interventions were guided by the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist, including evaluation data on effectiveness and process outcomes. The quality of the included literature was assessed using the Mixed Methods Appraisal Tool. RESULTS A total of 7 studies were included for review. Targeted NCDs included cardiovascular diseases (CVD; n=3), diabetes (n=3), and chronic obstructive pulmonary disease (n=1). The mean adherence (based on the number of follow-up responders) was 69% (SD 20%). Of the 7 studies, 4 with the highest adherence rates (80%) were also guided by behavior change theories and took an iterative, user-centered approach to development, optimizing intervention relevance. All 7 interventions presented algorithm-supported user guidance tools, including electronic decision support, smart features that interact with patterns of use, and behavior change stage-matching tools. Of the 7 studies, 6 assessed changes in behavior. Significant effects in moderate-to-vigorous physical activity were reported, but for no other specific health behaviors. However, positive behavior change was observed in studies that focused on comprehensive behavior change measures, such as self-care and self-management, each of which addresses several key lifestyle risk factors (eg, medication adherence). No significant difference was found for psychosocial outcomes (eg, quality of life). Significant changes in clinical outcomes were predominately related to disease-specific, multifaceted measures such as clinical disease control and cardiovascular risk score. CONCLUSIONS Iterative, user-centered development of digital platform structures could optimize user engagement with self-management support through existing, evidence-based digital interventions. Offering a palette of interventions with an appropriate degree of guidance has the potential to facilitate disease-specific health behavior change and effective self-management among a myriad of users, conditions, or stages of care.
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Development and Validation of an Application for Follow-up of Patients Undergoing Dialysis: NefroPortátil.
Pinto, LCS, Andrade, MC, Chaves, RO, Lopes, LLB, Maués, KG, Monteiro, AM, Nascimento, MB, Barros, CAV
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2020;(4):e51-e57
Abstract
OBJECTIVES To develop the NefroPortatil mobile application (app) and evaluate its effects on the management of patients undergoing dialysis. METHODS The first stage of the work was the development, installation, and establishment of the instructions to use the phone app as an instrument to aid in the control of fluid and food intake of 52 patients undergoing dialysis. In the second stage, the patients were monitored for 3 months and evaluated using questionnaires to measure the improvement in quality of life (Kidney Disease Quality of Life Instrument) and self-management of disease (Perceived Medical Condition Self-Management Scale) by the app. In addition, laboratory tests were performed before app use and in the first, second, and third months of its use (January to April 2018). Analysis of variance was used to analyze the laboratory data, and a paired Student's t test was used to analyze the responses to the questionnaires and as a posttest (P < .05). RESULTS Among the laboratory test results, serum phosphorus levels showed a significant difference (P < .04) after the app was used. A significant improvement was observed in self-management of the disease according to the Perceived Medical Condition Self-Management Scale questionnaire (P < .03). The usability of the app reached a median score of 9.65 from a total score of 10. CONCLUSION The NefroPortatil app improved the degree of perception of self-care of patients undergoing dialysis with chronic kidney failure, in addition to favoring nutritional control.
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Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial.
Yun, YH, Kang, E, Cho, YM, Park, SM, Kim, YJ, Lee, HY, Kim, KH, Lee, K, Koo, HY, Kim, S, et al
Journal of medical Internet research. 2020;(1):e15057
Abstract
BACKGROUND In addition to medication, health behavior management is crucial in patients with multiple risks of cardiovascular mortality. OBJECTIVE This study aimed to examine the efficacy of a 3-month Smart Management Strategy for Health-based electronic program (Smart Healthing). METHODS A 2-arm randomized controlled trial was conducted to assess the efficacy of Smart Healthing in 106 patients with at least one indicator of poor disease control and who had hypertension, diabetes, or hypercholesterolemia. The intervention group (n=53) took part in the electronic program, which was available in the form of a mobile app and a Web-based PC application. The program covered 4 areas: self-assessment, self-planning, self-learning, and self-monitoring by automatic feedback. The control group (n=53) received basic educational material concerning disease control. The primary outcome was the percentage of participants who achieved their clinical indicator goal after 12 weeks into the program: glycated hemoglobin (HbA1c) <7.0%, systolic blood pressure (SBP) <140 mmHg, or low-density lipoprotein cholesterol <130 mg/dL. RESULTS The intervention group showed a significantly higher success rate (in comparison with the control group) for achieving each of 3 clinical indicators at the targeted goal levels (P<.05). Only the patients with hypertension showed a significant improvement in SBP from the baseline as compared with the control group (72.7% vs 35.7%; P<.05). There was a significant reduction in HbA1c in the intervention group compared with the control group (difference=0.54%; P≤.05). In the intervention group, 20% of patients with diabetes exhibited a ≥1% decrease in HbA1c (vs 0% among controls; P≤.05). CONCLUSIONS A short-term self-management strategy-based electronic program intervention may improve clinical outcomes among patients with cardiovascular risks. TRIAL REGISTRATION ClinicalTrials.gov NCT03294044; https://clinicaltrials.gov/ct2/show/NCT03294044.
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Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial.
Li, Z, Chen, Q, Yan, J, Liang, W, Wong, WCW
BMC health services research. 2020;(1):57
Abstract
BACKGROUND To assess the effects of a motivational interviewing (MI)-based patient empowerment program (PEP) on type 2 diabetes mellitus (DM) patient self-management compared to traditional diabetes health education. METHODS Two hundred and twenty-five patients, recruited from community health centers (CHCs) and the family medicine clinic in the University of Hong Kong-Shenzhen Hospital in Shenzhen, were randomly assigned to the intervention or control groups. Patients in the intervention group (n = 117) received a four-session PEP in small groups over 1 month by trained nurses and doctors. The control group (n = 108) received the traditional lecture-style health education on DM. All the patients were followed up for 3 months. Outcomes included problem areas in diabetes (PAID) that measures diabetes-related emotional distress, patient enablement index (PEI), mental health, patient satisfaction respectively as well as lifestyle behaviors were assessed at baseline, post-activity and 3 months. RESULTS At post-intervention and the 3-month follow-up, the PAID score improved significantly in the intervention group (12.7 ± 13.6, 5.8 ± 7.6) compared to the control group (22.7 ± 22.8, 11.7 ± 14.6). No difference was found between groups for changes to exercise, diet, and medication adherence. The PEI score improved significantly at the 3-month follow-up in the MI group (7.27 ± 2.45 vs 5.81 ± 2.97). CONCLUSION The PEP has a significant effect on improving diabetes-related distress, but MI was not significantly different from the traditional health education programs when it comes to the readiness to change. TRIAL REGISTRATION NCT04120844, ClinicalTrials.Gov. Date of registration: October 9th 2019 (Retrospectively registered).
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Self-management education may improve blood pressure in people with type 2 diabetes. A randomized controlled clinical trial.
Trento, M, Fornengo, P, Amione, C, Salassa, M, Barutta, F, Gruden, G, Mazzeo, A, Merlo, S, Chiesa, M, Cavallo, F, et al
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2020;(11):1973-1979
Abstract
BACKGROUND AND AIMS Diabetes is a suitable model to evaluate intervention programmes aimed at chronic diseases, because of its well-defined and measurable process and outcome indicators. In this study, we aimed at investigating the effects of group based self-management education on clinical and psychological variables in type 2 diabetes. METHODS AND RESULTS Four-year randomized controlled clinical trial (ISRCTN14558376) comparing Group Care and traditional one-to-one care. Clinical and psychological variables were monitored at baseline, 2 and 4 years. Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls. Prescription of lipid-lowering and anti-hypertensive agents did not change among the patients on Group Care, whereas anti-hypertensives were stepped up among Controls without improving their blood pressure. Multivariable analysis suggests that blood pressure improvement among patients on Group Care was independent of BMI, duration of diabetes and antihypertensive medication, suggesting a direct effect of education, presumably by increasing adherence. The "Powerful Others" dimension of the Locus of Control worsened and fear of complications decreased among Controls. CONCLUSIONS The results confirm that a multidisciplinary structured group educational approach improves blood pressure, presumably through better adherence to healthy lifestyle and medication, in people with type 2 diabetes. CLINICAL TRIAL REGISTRATION NUMBER ISRCTN14558376.
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Effect of Behavioral Weight Management Interventions Using Lifestyle mHealth Self-Monitoring on Weight Loss: A Systematic Review and Meta-Analysis.
Cavero-Redondo, I, Martinez-Vizcaino, V, Fernandez-Rodriguez, R, Saz-Lara, A, Pascual-Morena, C, Álvarez-Bueno, C
Nutrients. 2020;(7)
Abstract
Alongside an increase in obesity, society is experiencing the development of substantial technological advances. Interventions that are easily scalable, such as lifestyle (including diet and physical activity) mobile health (mHealth) self-monitoring, may be highly valuable in the prevention and treatment of excess weight. Thus, the aims of this systematic review and meta-analysis were to estimate the following: (i) the effect of behavioral weight management interventions using lifestyle mHealth self-monitoring on weight loss and (ii) the adherence to behavioral weight management interventions using lifestyle mHealth self-monitoring. MEDLINE via PubMed, EMBASE, the Cochrane Central Register of Controlled Trials and the Web of Science databases were systematically searched. The DerSimonian and Laird method was used to estimate the effect of and adherence to behavioral weight management interventions using lifestyle mHealth self-monitoring on weight loss. Twenty studies were included in the systematic review and meta-analysis, yielding a moderate decrease in weight and higher adherence to intervention of behavioral weight management interventions using lifestyle mHealth self-monitoring, which was greater than other interventions. Subgroup analyses showed that smartphones were the most effective mHealth approach to achieve weight management and the effect of behavioral weight management interventions using lifestyle mHealth self-monitoring was more pronounced when compared to usual care and in the short-term (less than six months). Furthermore, behavioral weight management interventions using lifestyle mHealth self-monitoring showed a higher adherence than: (i) recording on paper at any time and (ii) any other intervention at six and twelve months.
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Psychological interventions to improve self-management of type 1 and type 2 diabetes: a systematic review.
Winkley, K, Upsher, R, Stahl, D, Pollard, D, Kasera, A, Brennan, A, Heller, S, Ismail, K
Health technology assessment (Winchester, England). 2020;(28):1-232
Abstract
BACKGROUND For people with diabetes mellitus to achieve optimal glycaemic control, motivation to perform self-management is important. The research team wanted to determine whether or not psychological interventions are clinically effective and cost-effective in increasing self-management and improving glycaemic control. OBJECTIVES The first objective was to determine the clinical effectiveness of psychological interventions for people with type 1 diabetes mellitus and people with type 2 diabetes mellitus so that they have improved (1) glycated haemoglobin levels, (2) diabetes self-management and (3) quality of life, and fewer depressive symptoms. The second objective was to determine the cost-effectiveness of psychological interventions. DATA SOURCES The following databases were accessed (searches took place between 2003 and 2016): MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, PsycINFO, EMBASE, Cochrane Controlled Trials Register, Web of Science, and Dissertation Abstracts International. Diabetes conference abstracts, reference lists of included studies and Clinicaltrials.gov trial registry were also searched. REVIEW METHODS Systematic review, aggregate meta-analysis, network meta-analysis, individual patient data meta-analysis and cost-effectiveness modelling were all used. Risk of bias of randomised and non-randomised controlled trials was assessed using the Cochrane Handbook (Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ 2011;343:d5928). DESIGN Systematic review, meta-analysis, cost-effectiveness analysis and patient and public consultation were all used. SETTING Settings in primary or secondary care were included. PARTICIPANTS Adolescents and children with type 1 diabetes mellitus and adults with types 1 and 2 diabetes mellitus were included. INTERVENTIONS The interventions used were psychological treatments, including and not restricted to cognitive-behavioural therapy, counselling, family therapy and psychotherapy. MAIN OUTCOME MEASURES Glycated haemoglobin levels, self-management behaviours, body mass index, blood pressure levels, depressive symptoms and quality of life were all used as outcome measures. RESULTS A total of 96 studies were included in the systematic review (n = 18,659 participants). In random-effects meta-analysis, data on glycated haemoglobin levels were available for seven studies conducted in adults with type 1 diabetes mellitus (n = 851 participants) that demonstrated a pooled mean difference of -0.13 (95% confidence interval -0.33 to 0.07), a non-significant decrease in favour of psychological treatment; 18 studies conducted in adolescents/children with type 1 diabetes mellitus (n = 2583 participants) that demonstrated a pooled mean difference of 0.00 (95% confidence interval -0.18 to 0.18), indicating no change; and 49 studies conducted in adults with type 2 diabetes mellitus (n = 12,009 participants) that demonstrated a pooled mean difference of -0.21 (95% confidence interval -0.31 to -0.10), equivalent to reduction in glycated haemoglobin levels of -0.33% or ≈3.5 mmol/mol. For type 2 diabetes mellitus, there was evidence that psychological interventions improved dietary behaviour and quality of life but not blood pressure, body mass index or depressive symptoms. The results of the network meta-analysis, which considers direct and indirect effects of multiple treatment comparisons, suggest that, for adults with type 1 diabetes mellitus (7 studies; 968 participants), attention control and cognitive-behavioural therapy are clinically effective and cognitive-behavioural therapy is cost-effective. For adults with type 2 diabetes mellitus (49 studies; 12,409 participants), cognitive-behavioural therapy and counselling are effective and cognitive-behavioural therapy is potentially cost-effective. The results of the individual patient data meta-analysis for adolescents/children with type 1 diabetes mellitus (9 studies; 1392 participants) suggest that there were main effects for age and diabetes duration. For adults with type 2 diabetes mellitus (19 studies; 3639 participants), baseline glycated haemoglobin levels moderated treatment outcome. LIMITATIONS Aggregate meta-analysis was limited to glycaemic control for type 1 diabetes mellitus. It was not possible to model cost-effectiveness for adolescents/children with type 1 diabetes mellitus and modelling for type 2 diabetes mellitus involved substantial uncertainty. The individual patient data meta-analysis included only 40-50% of studies. CONCLUSIONS This review suggests that psychological treatments offer minimal clinical benefit in improving glycated haemoglobin levels for adults with type 2 diabetes mellitus. However, there was no evidence of benefit compared with control interventions in improving glycated haemoglobin levels for people with type 1 diabetes mellitus. FUTURE WORK Future work should consider the competency of the interventionists delivering a therapy and psychological approaches that are matched to a person and their life course. STUDY REGISTRATION This study is registered as PROSPERO CRD42016033619. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 28. See the NIHR Journals Library website for further project information.