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Comparing Video-Based, Telehealth-Delivered Exercise and Weight Loss Programs With Online Education on Outcomes of Knee Osteoarthritis : A Randomized Trial.
Bennell, KL, Lawford, BJ, Keating, C, Brown, C, Kasza, J, Mackenzie, D, Metcalf, B, Kimp, AJ, Egerton, T, Spiers, L, et al
Annals of internal medicine. 2022;(2):198-209
Abstract
BACKGROUND Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions. OBJECTIVE To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention. DESIGN 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280). SETTING Australian private health insurance members. PARTICIPANTS 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years. INTERVENTION All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources. MEASUREMENTS Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery. RESULTS A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months. LIMITATION Participants and clinicians were unblinded. CONCLUSION Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise. PRIMARY FUNDING SOURCE Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence.
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Gluten-Free Diet: Nutritional Strategies to Improve Eating Habits in Children with Celiac Disease: A Prospective, Single-arm Intervention Study.
Suárez-González, M, Bousoño-García, C, Jiménez-Treviño, S, Díaz-Martín, JJ
Nutrients. 2021;(4)
Abstract
BACKGROUND Elimination of gluten-containing cereals and consumption of ultra-processed gluten-free foods might cause an unbalanced diet, deficient in fiber and rich in sugar and fat, circumstances that may predispose celiac children to chronic constipation. AIM: to evaluate if counseling with a registered dietitian (RD) was capable of improving eating and bowel habits in a celiac pediatric population. METHODS Dietetic, lipid profile and stool modifications were analyzed, comparing baseline assessments with those twelve months after receiving heathy eating and nutrition education sessions. At both time points, 3-day food records, a bowel habit record and a lipid panel were conducted. Calculated relative intake of macro- and micro-nutrients were compared with current recommendations by the European Food Safety Authority (EFSA). Student's paired t-test, McNemar test, Mandasky test and Pearson correlation tests were used. RESULTS Seventy-two subjects (58.3% girls) with a mean (standard deviation (SD)) age of 10.2 (3.4) years were included. Baseline diets were imbalanced in macronutrient composition. Significant improvements were observed in their compliance with dietary reference values (DRVs), where 50% of the subjects met fat requirements after the education and 67% and 49% with those of carbohydrates and fiber, respectively (p < 0.001). Celiac children decreased red meat and ultra-processed foods consumption (p < 0.001) and increased fruits and vegetables intake (p < 0.001), leading to a reduction in saturated fat (p < 0.001) and sugar intake (p < 0.001). Furthermore, 92% of the patients achieved a normal bowel habit, including absence of hard stools in 80% of children constipated at baseline (p < 0.001). CONCLUSIONS RD-led nutrition education is able to improve eating patterns in children with celiac disease (CD).
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The impact of structured diabetes education on glycemic control during Ramadan fasting in diabetic patients in Beni Suef, Egypt.
Nassar, M, Ahmed, TM, AbdAllah, NH, El Sayed El Hadidy, K, Sheir, RE
Diabetes & metabolic syndrome. 2021;(5):102249
Abstract
AIMS: Ramadan is a holy month for the Muslim community. Fasting Ramadan is directed by a systematic alteration in eating habits, sleeping times, and daily physical activities that optimize blood glucose levels. This study aims to evaluate the effects of structured education on safe fasting among diabetic patients. METHODS This study included diabetic patients with eligibility for the Ramadan fast. The control group included 494 patients who received standard diabetes education, while the intervention group included 407 patients who attained structured diabetes education. The patients were required to register their responses following the written, structured questionnaires before and after Ramadan fasts. In addition, patients were advised to keep a log of their hypoglycemic episodes. RESULT This study showed that structured diabetes education improved the blood glucose levels/glycemic control and outcomes of patients during their Ramadan fasting. The structured diabetes education helped reduce the incidence of hypoglycemic events and hyperglycemic crises. It also increased the acceptance and frequency of blood sugar level measurements among patients during Ramadan. CONCLUSION The standard diabetes management plan should include structured diabetes education measures to improve outcomes effectively. The providers should screen the patients with diabetes before Ramadan and educate them to improve their safe fasting practices.
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The effect of educational program based on theory of planned behavior on promoting retinopathy preventive behaviors in patients with type 2 diabetes: RCT.
Hosseini, SS, Shamsi, M, Khorsandi, M, Moradzadeh, R
BMC endocrine disorders. 2021;(1):17
Abstract
BACKGROUND Diabetic retinopathy is the most common microvascular complication of diabetes and it is a leading cause of visual impairment and blindness among patients with diabetes. This study aimed to investigate the effect of educational program based on Theory of Planned Behavior (TPB) on promoting retinopathy preventive behaviors in patients with type 2 diabetes. METHODS The present study is an educational randomized controlled trial research that was conducted on 94 patients with type 2 diabetes who had gone to diabetes clinic. The samples were randomly assigned to the intervention (N = 47) and control groups (N = 47). Data collection instrument was a researcher-made questionnaire based on TPB and FBS and HbA1C tests. Then, educational program was performed for the intervention group through four educational sessions. After 3 months, data collection was repeated for the two groups and FBS, HbA1C testes were done again and data were analyzed. RESULTS The performance of the intervention group on preventive behaviors of retinopathy increased from 2.48 ± 1.42 to 4.48 45 1.45 after the education (p < 0.001). The mean of FBS and HbA1c in the intervention group also decreased after the intervention (P < 0.05). CONCLUSION Applying the TPB model proved is very effective in developing an educational program for patients with diabetes, to control their blood sugar and enhance preventive behaviors of retinopathy. Besides such programs, follow-up education for controlling and monitoring are highly recommended. This theory serves as a helpful theoretical framework for health-related behaviors and can be an appropriate pattern to plan for educational interventions. TRIAL REGISTRATION This trial has been registered at Iranian Registry of Clinical Trials, IRCT20180819040834N1 . Prospectively registered 8 Apr 2019, https://en.irct.ir/trial/38401.
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Effect of a Smartphone App on Weight Change and Metabolic Outcomes in Asian Adults With Type 2 Diabetes: A Randomized Clinical Trial.
Lim, SL, Ong, KW, Johal, J, Han, CY, Yap, QV, Chan, YH, Chooi, YC, Zhang, ZP, Chandra, CC, Thiagarajah, AG, et al
JAMA network open. 2021;(6):e2112417
Abstract
IMPORTANCE Lifestyle interventions are effective in diabetes management, with smartphone apps that manage health data and dietary and exercise schedules gaining popularity. However, limited evidence from randomized clinical trials exists regarding the effectiveness of smartphone-based interventions among Asian adults with type 2 diabetes. OBJECTIVE To compare the effects of a culturally contextualized smartphone-based intervention with usual care on weight and metabolic outcomes. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial conducted at multiple primary care centers in Singapore included 305 adults with type 2 diabetes and body mass index (BMI) of 23 or greater who had literacy in English and smartphone access. Participants were recruited between October 3, 2017, and September 9, 2019, and were randomly assigned (1:1; stratified by gender, age, and BMI) to intervention (99 participants) or control (105 participants) groups. Participants' data were analyzed using intention-to-treat analysis. INTERVENTIONS Both control and intervention participants received diet and physical activity advice from a dietitian at a baseline face-to-face visit. Intervention participants additionally used a smartphone app to track weight, diet, physical activity, and blood glucose and then communicated with dietitians for 6 months. MAIN OUTCOMES AND MEASURES Primary outcome was change in body weight, while secondary outcomes were changes in hemoglobin A1c (HbA1c), fasting blood glucose, blood pressure, lipids, and diet. Post hoc analyses included glycemic changes in the subgroup with HbA1c levels of 8% or greater and diabetes medication changes. RESULTS Among the 204 randomized participants (mean [SD] age, 51.2 [9.7] years; 132 [64.7%] men), baseline mean (SD) BMI was 30.6 (4.3). Compared with the control group, intervention participants achieved significantly greater reductions in weight (mean [SD] change, -3.6 [4.7] kg vs -1.2 [3.6] kg) and HbA1c levels (mean [SD] change, -0.7% [1.2] vs -0.3% [1.0]), with a greater proportion having a reduction in diabetes medications (17 participants [23.3%] vs 4 participants [5.4%]) at 6 months. The intervention led to a greater HbA1c reduction among participants with HbA1c levels of 8% or higher (mean [SD] change, -1.8% [1.4] vs -1.0% [1.4]; P = .001). Intergroup differences favoring the intervention were also noted for fasting blood glucose, diastolic blood pressure, and dietary changes. CONCLUSIONS AND RELEVANCE In this study, a smartphone-based lifestyle intervention was more effective in achieving weight and glycemic reductions among Asian adults with type 2 diabetes compared with usual care, supporting the use of apps in lifestyle intervention delivery. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12617001112358.
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Are education, exercise and diet interventions a cost-effective treatment to manage hip and knee osteoarthritis? A systematic review.
Mazzei, DR, Ademola, A, Abbott, JH, Sajobi, T, Hildebrand, K, Marshall, DA
Osteoarthritis and cartilage. 2021;(4):456-470
Abstract
OBJECTIVE To identify research gaps and inform implementation we systematically reviewed the literature evaluating cost-effectiveness of recommended treatments (education, exercise and diet) for the management of hip and/or knee OA. METHODS We searched Medline, Embase, Cochrane Central Register of Controlled Trials, National Health Services Economic Evaluation Database, and EconLit from inception to November 2019 for trial-based economic evaluations investigating hip and/or knee OA core treatments. Two investigators screened relevant publications, extracted data and synthesized results. Risk of bias was assessed using the Consensus on Health Economic Criteria list. RESULTS Two cost-minimization, five cost-effectiveness and 16 cost-utility analyses evaluated core treatments in six health systems. Exercise therapy with and without education or diet was cost-effective or cost-saving compared to education or physician-delivered usual care at conventional willingness to pay (WTP) thresholds in 15 out of 16 publications. Exercise interventions were cost-effective compared to physiotherapist-delivered usual care in three studies at conventional WTP thresholds. Education interventions were not cost-effective compared to usual care or placebo at conventional WTP thresholds in three out of four publications. CONCLUSIONS Structured core treatment programs were clinically effective and cost-effective, compared to physician-delivered usual care, in five health care systems. Providing education about core treatments was not consistently cost-effective. Implementing structured core treatment programs into funded clinical pathways would likely be an efficient use of health system resources and enhance physician-delivered usual primary care.
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TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain-Protocol of a Randomized Controlled Trial.
Fritsch, CG, Ferreira, PH, Prior, JL, Clavisi, O, Chow, CK, Redfern, J, Thiagalingam, A, Lung, T, McLachlan, AJ, Ferreira, ML
Physical therapy. 2021;(7)
Abstract
OBJECTIVE The authors sought to describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control in people with low back pain (LBP). METHODS A single-blind (assessor and statistician), randomized controlled trial with economic analysis and process evaluation will be conducted. A total of 304 people with non-specific LBP of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive 4 semi-personalized text messages per week providing advice, motivation, and information about LBP, physical activity, sleep, mood, use of care, and medication during 12 weeks. The control group will receive 1 text message with a link to a LBP and diet online information package. Outcomes will be assessed at baseline and 3, 6, and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life, and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization, and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted. IMPACT This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with LBP. This study can inform clinical practice of a simple, scalable, and affordable intervention for managing LBP.
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Intervention Value of Path-Type Health Education on Cognition and Renal Function of Patients with Diabetic Nephropathy.
Bao, L
Computational and mathematical methods in medicine. 2021;:3665460
Abstract
OBJECTIVE Analyze and examine the effectiveness of path-based health education for patients with diabetic nephropathy and renal function. METHODS The 162 diabetic nephropathy patients admitted to our hospital from January 2018 to January 2021 were selected, and participants were randomly assigned to groups: study group (n = 79) and control group (n = 83). The control group received routine nursing care, whereas the study group received path-type health education. GQOLI-74, MUIS-A scores, biochemical indicators, dietary indicators, cognition, blood glucose levels, and renal function were compared between the two groups. RESULTS The GQOLI-74 score of the two groups was substantially higher, while the MUIS-A score was significantly lower, although the study group changed more significantly (P < 0.05) than the control group. The biochemical markers in both groups decreased significantly, but the study group changed more dramatically (P0.05) than the control group; the nutritional index values of both groups increased significantly, but the study group's nutritional index values increased significantly (P0.05) when compared to those of the control group; the control group's awareness of drug treatment, basic knowledge, exercise, and diet was 79.4 percent, 78.9 percent, 73.4 percent, and 91.0 percent, respectively, and the study group's awareness of drug treatment, basic knowledge, exercise, and diet was 90.3%, 96.4%, 92.8%, and 94.0%. The study group exhibited greater awareness (P0.05) than the control group. The blood glucose indices of both groups were dramatically lowered; however, the study group's blood glucose level declined more significantly (P0.05) than the control group. The renal function indices of both groups were considerably lower, but the study group's renal function indexes were significantly lower (P0.05) than those of the control group. CONCLUSION Pathway health education is a new nursing method that can adjust nutritional indicators, improve blood sugar and kidney function, and significantly increase patients' awareness of the disease, which can further improve patient compliance with treatment. This nursing method has high application feasibility and high clinical value.
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Mobile health technologies supporting colonoscopy preparation: A systematic review and meta-analysis of randomized controlled trials.
El Bizri, M, El Sheikh, M, Lee, GE, Sewitch, MJ
PloS one. 2021;(3):e0248679
Abstract
BACKGROUND Mobile health (mHealth) technologies are innovative solutions for delivering instructions to patients preparing for colonoscopy. OBJECTIVE To systematically review the literature evaluating the effectiveness of mHealth technologies supporting colonoscopy preparation on patient and clinical outcomes. METHODS MEDLINE, EMBASE, CINAHL and CENTRAL were searched for randomized controlled trials (RCTs) that evaluated the effectiveness of mHealth technologies for colonoscopy preparation on patient and clinical outcomes. Two reviewers independently assessed study eligibility, extracted data, and appraised methodological quality using the Cochrane Risk-of-Bias tool. Data were pooled using random effects models and when heterogeneity, assessed using I2, was statistically significant, a qualitative synthesis of the data was performed. Publication bias was assessed using a funnel plot. RESULTS Ten RCTs (3,383 participants) met inclusion criteria. MHealth interventions included smartphone apps, SMS text messages, videos, camera apps, and a social media app. Outcomes were bowel cleanliness quality, user satisfaction, colonoscopy quality indicators (cecal intubation time, withdrawal time, adenoma detection rate), adherence to diet, and cancellation/no-show rates. MHealth interventions were associated with better bowel cleanliness scores on the Boston Bowel Preparation Scale [standardized mean difference (SMD) 0.57, 95%CI 0.37-0.77, I2 = 60%, p = 0.08] and the Ottawa Bowel Preparation Scale [SMD -0.39, 95%CI -0.59-0.19, I2 = 45%, p = 0.16], but they were not associated with rates of willingness to repeat the colonoscopy using the same regimen [odds ratio (OR) 1.88, 95%CI 0.85-4.15, I2 = 48%, p = 0.12] or cancellations/no-shows [OR 0.96, 95%CI 0.68-1.35, I2 = 0%]. Most studies showed that adequate bowel preparation, user satisfaction and adherence to diet were better in the intervention groups compared to the control groups, while inconsistent findings were observed for the colonoscopy quality indicators. All trials were at high risk of bias for lack of participant blinding. Visual inspection of a funnel plot revealed publication bias. CONCLUSIONS MHealth technologies show promise as a way to improve bowel cleanliness, but trials to date were of low methodological quality. High-quality research is required to understand the effectiveness of mHealth technologies on colonoscopy outcomes.
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Effectiveness of a Female Community Health Volunteer-Delivered Intervention in Reducing Blood Glucose Among Adults With Type 2 Diabetes: An Open-Label, Cluster Randomized Clinical Trial.
Gyawali, B, Sharma, R, Mishra, SR, Neupane, D, Vaidya, A, Sandbæk, A, Kallestrup, P
JAMA network open. 2021;(2):e2035799
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Abstract
IMPORTANCE Female community health volunteers (FCHVs) are frontline community health workers who have been a valuable resource in improving public health outcomes in Nepal, but their value is understudied in diabetes care. OBJECTIVE To assess whether an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS This community-based, open-label, 2-group, cluster randomized clinical trial with a 12-month delayed control group design was conducted in 14 clusters of a semiurban setting in Western Nepal. A total of 244 adults with type 2 diabetes were recruited between November 2016 and April 2017. The follow-up assessment was conducted at 12 months after enrollment. Data analysis was performed from January to February 2019. INTERVENTIONS Seven clusters were randomized to the FCHV-delivered intervention in which 20 FCHVs provided home visits 3 times a year (once every 4 months) for health promotion counseling and blood glucose monitoring. If participants had blood glucose levels of 126 mg/dL or higher, the FCHVs referred them to the nearest health facility, and if participants were taking antihyperglycemic medication, they were followed up by the FCHVs for adherence to their medication. Seven clusters were randomized to usual care (control group). MAIN OUTCOMES AND MEASURES The primary outcome was the change in mean fasting blood glucose from baseline to 12-month follow-up. Secondary outcomes included changes in mean systolic blood pressure, mean diastolic blood pressure, mean body mass index, percentage change in the proportion of low physical activity, harmful alcohol consumption, current smoking, low fruit and vegetable intake, and antihyperglycemic medication status. RESULTS Of 244 participants, 120 women (56.6%) and 92 men (43.4%) completed the trial. At baseline, the mean (SD) age was 51.71 (8.77) years; 127 participants were in the intervention group, and 117 participants were in the control group (usual care). At baseline, the mean (SD) fasting blood glucose level was 156.06 (44.48) mg/dL (158.48 [45.50] mg/dL in the intervention group and 153.43 [43.39] mg/dL in the control group). At 12-month follow-up, the mean fasting blood glucose decreased by 22.86 mg/dL in the intervention group, whereas it increased by 7.38 mg/dL in the control group. The mean reduction was 27.90 mg/dL greater with the intervention (95% CI, -37.62 to -18.18 mg/dL; P < .001). In secondary outcome analyses, there was a greater decline in mean systolic blood pressure in the intervention group than in the control group (-5.40 mm Hg; 95% CI, -8.88 to -1.92 mm Hg; P = .002). There was detectable difference in the intake of antihyperglycemic medication between the groups (relative risk, 1.35; 95% CI, 1.1 to 1.74; P = .02). CONCLUSIONS AND RELEVANCE These findings suggest that an FCHV-delivered intervention is associated with reduced blood glucose levels among adults with type 2 diabetes in a low-resource setting in Nepal. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03304158.