Influence of education training in patients with type 2 diabetes in the improvement of lifestyle and biochemical characteristics: a randomized controlled trial

Abstract Objective The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin (HbA1c), blood pressure, triglyceride, cholesterol levels, and body mass index (BMI). Methods The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups (control and intervention). The education training (four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant. Results There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1c was significantly lower than the value in the control group (6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction (more than 15%) in HbA1c after the intervention was 43% in the intervention group and 2% in the control group (OR = 36.9, P < 0.05). Differences in BMI, HbA1c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same (P > 0.05). Conclusions The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.

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A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

Journal of Medical Internet Research ◽

10.2196/16629 ◽

2020 ◽

Vol 22 (5) ◽

pp. e16629 ◽

Cited By ~ 2

Author(s):

Aikaterini Kassavou ◽

Venus Mirzaei ◽

James Brimicombe ◽

Simon Edwards ◽

Efthalia Massou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Control Group ◽

Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

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A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness (Preprint)

10.2196/preprints.16629 ◽

2019 ◽

Author(s):

Aikaterini Kassavou ◽

Venus Mirzaei ◽

James Brimicombe ◽

Simon Edwards ◽

Efthalia Massou ◽

...

Keyword(s):

Type 2 Diabetes ◽

Primary Care ◽

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Clinical Effectiveness ◽

Control Group ◽

Randomized Controlled

BACKGROUND The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. OBJECTIVE This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. METHODS This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. RESULTS A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. CONCLUSIONS Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

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Improving Self-Care in Patients With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/16769 ◽

2020 ◽

Vol 22 (3) ◽

pp. e16769 ◽

Cited By ~ 2

Author(s):

Calvin Kalun Or ◽

Kaifeng Liu ◽

Mike K P So ◽

Bernard Cheung ◽

Loretta Y C Yam ◽

...

Keyword(s):

Blood Pressure ◽

Type 2 Diabetes ◽

Chronic Disease ◽

Care Management ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Control Group ◽

Randomized Controlled

Background Technological surrogate nursing (TSN) derives from the idea that nurse-caregiver substitutes can be created by technology to support chronic disease self-care. Objective This paper begins by arguing that TSN is a useful and viable approach to chronic disease self-care. The analysis then focuses on the empirical research question of testing and demonstrating the effectiveness and safety of prototype TSN supplied to patients with the typical complex chronic disease of coexisting type 2 diabetes and hypertension. At the policy level, it is shown that the data allow for a calibration of TSN technology augmentation, which can be readily applied to health care management. Methods A 24-week, parallel-group, randomized controlled trial (RCT) was designed and implemented among diabetic and hypertensive outpatients in two Hong Kong public hospitals. Participants were randomly assigned to an intervention group, supplied with a tablet-based TSN app prototype, or to a conventional self-managing control group. Primary indices—hemoglobin A1c, systolic blood pressure, and diastolic blood pressure—and secondary indices were measured at baseline and at 8, 12, 16, and 24 weeks after initiation, after which the data were applied to test TSN effectiveness and safety. Results A total of 299 participating patients were randomized to the intervention group (n=151) or the control group (n=148). Statistically significant outcomes that directly indicated TSN effectiveness in terms of hemoglobin 1c were found in both groups but not with regard to systolic and diastolic blood pressure. These findings also offered indirect empirical support for TSN safety. Statistically significant comparative changes in these primary indices were not observed between the groups but were suggestive of an operational calibration of TSN technology augmentation. Statistically significant changes in secondary indices were obtained in one or both groups, but not between the groups. Conclusions The RCT’s strong behavioral basis, as well as the importance of safety and effectiveness when complex chronic illness is proximately self-managed by layperson patients, prompted the formulation of the empirical joint hypothesis that TSN would improve patient self-care while satisfying the condition of patient self-safety. Statistical and decision analysis applied to the experimental outcomes offered support for this hypothesis. Policy relevance of the research is demonstrated by the derivation of a data-grounded operational calibration of TSN technology augmentation with ready application to health care management. Trial Registration ClinicalTrials.gov NCT02799953; https://clinicaltrials.gov/ct2/show/NCT02799953

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Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

Clinical Oral Investigations ◽

10.1007/s00784-021-03908-6 ◽

2021 ◽

Author(s):

K. Wernicke ◽

J. Grischke ◽

M. Stiesch ◽

S. Zeissler ◽

K. Krüger ◽

...

Keyword(s):

Physical Activity ◽

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Periodontal Health ◽

Randomized Controlled ◽

Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

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The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2020-0245 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Asieh Mehdipour ◽

Parvin Abedi ◽

Somayeh Ansari ◽

Maryam Dastoorpoor

Keyword(s):

Randomized Controlled Trial ◽

Postmenopausal Women ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Moderate Depression ◽

Before And After ◽

The Mean ◽

And Control

Abstract Objectives Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women. Methods This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data. Results The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001). Conclusions The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended.

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Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17062096 ◽

2020 ◽

Vol 17 (6) ◽

pp. 2096

Author(s):

Haiquan Xu ◽

Yanzhi Guo ◽

Shijun Lu ◽

Yunqian Ma ◽

Xiuli Wang ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Controlled Trial ◽

Systolic Blood Pressure ◽

Total Cholesterol ◽

Controlled Trial ◽

Intervention Group ◽

High Density Lipoproteins ◽

Control Group ◽

Randomized Controlled ◽

Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

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