Effect of a multifactorial intervention on the increase in physical activity in subjects with type 2 diabetes mellitus: a randomized clinical trial (EMID Study)

2019 ◽  
Vol 18 (5) ◽  
pp. 399-409 ◽  
Author(s):  
Rosario Alonso-Domínguez ◽  
María C Patino-Alonso ◽  
Natalia Sánchez-Aguadero ◽  
Luis García-Ortiz ◽  
Jose I Recio-Rodríguez ◽  
...  

Background: Regular physical activity is essential for metabolic control in type 2 diabetes mellitus. Aims: The aim of this study was to assess the short and long-term impact of a multifactorial intervention on physical activity and clinically relevant biochemical parameters in patients with type 2 diabetes mellitus. Methods: This randomised, controlled clinical trial (NCT02991079) included two parallel groups aged 25–70 years from a primary care health centre in Salamanca, Spain. The subjects were assigned randomly (1:1) to control and intervention groups, using Epidat 4.0 software. Both were counselled on the importance of physical activity and maintaining a healthy diet. The intervention group also took five low–moderate intensity 4 km nurse-guided walks, received a smartphone application to promote healthy habits and attended a diet workshop. Physical activity was measured objectively using a pedometer and subjectively using a shortened international physical activity questionnaire (at baseline, 3 and 12 months). Results: In total, 204 subjects were included (mean age 60.6 years, 45.6% were women). After 3 months, relative to the control group, the intervention group increased their daily number of steps by 1852, aerobic steps by 1623, distance walked by 994 m, and total metabolic equivalent minutes per week by 1297 and decreased sedentary time by 34.3 minutes per day. Differences from baseline persisted at 12 months, including mean increases of 1141 daily steps, 917 aerobic steps, and 1065 total metabolic equivalent minutes per week in the intervention group relative to the control group ( P<0.05 for all). Conclusions: The success of this multifactorial intervention should help inform future clinical approaches and application designs towards managing type 2 diabetes mellitus and improving patient outcomes.

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Rezvan Ghafarzadegan ◽  
Javad Javaheri ◽  
Mina Asgari ◽  
Mohammad Golitaleb ◽  
Fatemeh Maraki ◽  
...  

Objectives: The present study aimed to investigate the potential effects of the combined herbal capsule (CHC), as a nutritional supplement, on glycemic indices (GIs) and lipid profile (LP) of patients with type 2 diabetes mellitus (T2DM). Methods: Following a randomized, single-blind, placebo-controlled clinical trial, the current study was conducted on 80 cases with T2DM who were randomly assigned into two groups of treatment (CHCs; n = 40) and control (placebo; n = 40). Both groups received the intervention (500 mg capsules) twice a day for three months, without changes in the previous dose of oral anti-hyperglycemic drugs. The GI and LP levels were measured before the intervention and three months later to investigate the potential efficacy of the interventions. Results: For those in the intervention group, the mean GI [i.e., fasting blood sugar, two hours postprandial (2hpp), and HbA1c] was significantly different after 3 months (P < 0.05). The GI- and LP-related outcomes (TG, LDL-C except for TC) were improved after 3-month of receiving the intervention compared to the control group; however, the observed improvement was no statistically significant (P > 0.05). The HDL-C level was also significantly improved in the intervention group compared to the control group (P < 0.05). Conclusions: This study demonstrated that receiving CHCs could improve GI and LP levels (TG, LDL-C, and HDL-C, except for TC), which indicates its potential to control T2DM. Moreover, no significant side effect was observed in the intervention group. It can be argued that the use of CHCs, as adjuvant therapy, in combination with conventional hypoglycemic and lipid-lowering drugs, as well as following a modified lifestyle, not only can significantly enhance glycemic control but also may prevent T2DM complications.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anja Wollny ◽  
Christin Löffler ◽  
Eva Drewelow ◽  
Attila Altiner ◽  
Christian Helbig ◽  
...  

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups. Conclusions The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness. Trial registration The trial was registered on March 10th, 2011 at ISRCTN registry under the reference ISRCTN70713571.


Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  

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.


2021 ◽  
Author(s):  
◽  
Julio Cesar Loya

Limited information is available regarding culturally-tailored physical activity (PA) interventions for Hispanic adults with type 2 diabetes mellitus (T2DM). A community-partnered approach was used to examine a novel culturally-tailored PA intervention using a pre-post, no control group design. The intervention consisted of six weekly 45-minute sessions for participants to engage in PA led by the researcher. A total of 21 individuals participated in the study. The typical participant was a 53-year-old female (90 percent) Hispanic adult living with T2DM with low acculturation. On average, before the intervention, the participants walked 10,285 (sd 14,779) steps per week with 43.4 (sd 68.1) minutes of PA per week. Despite implementation during the COVID-19 pandemic, the intervention was feasible and acceptable, and 19 (90.5 percent) participants attended all intervention sessions. There were significant increases in steps per week (p=0.007; d=1.03) and minutes of PA per week (p=0.000; d=1.62). Findings suggest that Salud Paso por Paso has promise as a strategy to enhance PA behaviors in the priority population. A randomized, controlled trial with a larger study sample is warranted to examine efficacy and impact on the diabetes health outcomes of Hispanic adults with T2DM.


2018 ◽  
Vol 68 (667) ◽  
pp. e139-e145 ◽  
Author(s):  
Ayorinde F Fayehun ◽  
Olufemi O Olowookere ◽  
Adetola M Ogunbode ◽  
Adedotun A Adetunji ◽  
Arinola Esan

BackgroundIn clinical practice, translating the benefits of a sustained physically active lifestyle on glycaemic control in patients with type 2 diabetes mellitus (T2DM) is difficult. A walking prescription may be an effective alternative.AimTo examine the effect of a 10 000 steps per day prescription on glycaemic control of patients with T2DM.Design and settingForty-six adults with T2DM attending a general outpatient clinic were randomised into two equal groups. The intervention group was given goals to accumulate 10 000 steps per day for 10 weeks, whereas the control group maintained their normal activity habits.MethodDaily step count was measured with waist-mounted pedometer and baseline and endline average steps per day. Glycosylated haemoglobin (HbA1c), anthropometric, and cardiovascular measurements were also obtained. An intention-to-treat analysis was done.ResultsThe average baseline step count was 4505 steps per day for all participants, and the average step count in the intervention group for the last 4 weeks of the study period was higher by 2913 steps per day (95% confidence interval [CI] = 1274 to 4551, F (2, 37.7) = 18.90, P<0.001). Only 6.1% of the intervention group participants achieved the 10 000 steps per day goal. The mean baseline HbA1c was 6.6% (range = 5.3 to 9.0). Endline HbA1c was lower in the intervention group than in the control group (mean difference −0.74%, 95% CI = −1.32 to −0.02, F = 12.92, P = 0.015) after adjusting for baseline HbA1c. There was no change in anthropometric and cardiovascular indices.ConclusionAdherence to 10 000 steps per day prescription is low but may still be associated with improved glycaemic control in T2DM. Motivational strategies for better adherence would improve glycaemic control.


2016 ◽  
Vol 26 (2) ◽  
pp. 241-253 ◽  
Author(s):  
Mahdi Moshki ◽  
Atefeh Dehnoalian ◽  
Ali Alami

This study sought to assess the effect of precede–proceed model on preventive behaviors for type 2 diabetes mellitus (DM) in high-risk individuals. In this semi-experimental study, 164 high-risk individuals for type 2 DM were selected and were randomly divided into two groups of intervention and control ( n = 85). Educational intervention was performed as a single session face-to-face instruction for 1.5 hr for the intervention group participants. Data were collected before (baseline) and immediately and 1 month after the intervention in the two groups. The mean score of predisposing (knowledge) factors ( p = .001), reinforcing factors ( p = .001), and enabling factors ( p = .02) were significantly different at baseline and 1 month after the intervention in the intervention group compared with the control group ( p < .05). A significant improvement occurred in the nutritional habits of high-risk participants in the intervention group at 1 month after the intervention compared with controls ( p = .001). The precede–proceed model can be effective for promoting the preventive behaviors for type 2 DM in high-risk individuals.


Author(s):  
Aizuddin Hidrus ◽  
Yee Cheng Kueh ◽  
Bachok Norsaádah ◽  
Yu-Kai Chang ◽  
Tsung-Min Hung ◽  
...  

Brain Breaks videos are web-based structured physical activity (PA) videos that aim at stimulating an interest in learning and promoting health. Exercise is one of the important treatment regimens for people with type 2 diabetes mellitus (T2DM). Thus, the objective of this study was to determine the effects that Brain Breaks videos have on the motives for PA, as measured by the Physical Activity and Leisure Motivation Scale-Malay (PALMS-M), and the amount of PA, as measured by the International Physical Activity Questionnaire-Malay (IPAQ-M), in T2DM patients (the most common type of diabetes mellitus patients). This study was conducted using a randomized, double-blind design and grouped subjects under two research conditions: an experimental group given Brain Breaks videos and a control group. Purposive sampling was employed to recruit 70 T2DM patients (male = 39, female = 31) with the mean age of 57.6 (SD = 8.5) from Hospital Universiti Sains Malaysia, Kelantan. Over a four-month period, the participants in the experimental group were asked to perform PA daily based on a Brain Breaks video (10 min in duration) that was shared through a WhatsApp group. All participants from both groups answered the PALMS-M questionnaire five times: pre-intervention, the end of the first month, second month, and third month, and post-intervention. A repeated measure multivariate analysis of variance and a repeated measure analysis of variance were performed for the analyses of the data. The results demonstrated that four (appearance, others’ expectations, physical condition, and mastery) out of eight motives for PA produced a significant mean score difference between the two study groups. All eight motives for PA showed an upward trend for the experimental group during the study period, while the control group showed a downward trend for all motives during the study period. As for the amount of PA, both groups showed significant differences (p = 0.001). The amount of PA increased in the experimental group during the study period, while it decreased in the control group. Therefore, Brain Breaks videos can be considered as an effective intervention for motivating T2DM patients for PA and improving their amount of PA.


2020 ◽  
Vol 20 (7) ◽  
pp. 1090-1096
Author(s):  
Yusuf Bozkuş ◽  
Umut Mousa ◽  
Özlem T. İyidir ◽  
Nazlı Kırnap ◽  
Canan Ç. Demir ◽  
...  

Objective: Proton pump inhibitor (PPI) drugs reduce gastric acid secretion and lead to an increase in serum gastrin levels. Many preclinical and some clinical researches have established some positive effects of gastrin or PPI therapy on glucose regulation. The aim of this study was to prospectively investigate the short term effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. In addition, the presence of an association between this effect and gastrin levels was evaluated. Methods: Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16). The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at the 3rd month, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then, the groups were compared in terms of their baseline and 3rd month values. Results: In the intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001). The mean HbA1c level was similar to the pre-treatment level (6.3±0.7% vs. 6.4±0.9%, p=0.441). There were no statistically significant differences in all parameters of the control group. The majority of individuals were on metformin monotherapy (65.6 %). The subgroup analysis of metformin monotherapy revealed that, in intervention group, there was a significant increase in gastrin levels (39.9±12.6 vs. 95.5±52.5, p=0.026), but the HbA1c levels did not change (6.0±0.4 % vs. 5.9±0.6 %, p=0.288); and in control group, gastrin levels did not change (37.5 ± 26.7 vs. 36.1 ±23.3, p=0.367), but there was an increase in HbA1c levels (6.1 ± 0.50 vs. 6.4 ± 0.60, p=0.01). Conclusion: Our study demonstrates that esomeprazole has no extra benefit for the controlled diabetic patient in three months. However, in only the metformin-treated subgroup, esomeprazole may prevent the rise in HbA1c level.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e044478
Author(s):  
Travis J Hrubeniuk ◽  
Danielle R Bouchard ◽  
Brendon J Gurd ◽  
Martin Sénéchal

IntroductionExercise is recommended to improve glycaemic control. Yet, individual changes in glycaemic control following exercise can vary greatly, meaning while some significantly improve others, coined ‘non-responders’, do not. Increasing the intensity of exercise may ‘rescue’ non-responders and help generate a response to training. This trial will identify non-responders to changes in glycated haemoglobin (HbA1c) across inactive individuals living with pre-diabetes or type 2 diabetes mellitus following an aerobic exercise programme and evaluate if increasing training intensity will elicit beneficial changes to ‘rescue’ previously categorised non-responders.Methods and analysisThis study will recruit 60 participants for a two-phase aerobic exercise training programme. Participants will be allocated to a control group or assigned to an intervention group. Control participants will maintain their current lifestyle habits. During phase 1, intervention participants will complete 16 weeks of aerobic exercise at an intensity of 4.5 metabolic equivalents (METs) for 150 min per week. Participants will then be categorised as responders or non-responders based on the change in HbA1c. For phase 2, participants will be blocked based on responder status and randomly allocated to a maintained intensity, or increased intensity group for 12 weeks. The maintained group will continue to train at 4.5 METs, while the increased intensity group will train at 6.0 METs for 150 min per week.Ethics and disseminationResults will be presented at scientific meetings and submitted to peer-reviewed journals. Publications and presentations related to the study will be authorised and reviewed by all investigators. Findings from this study will be used to provide support for future randomised control trials. All experimental procedures have been approved by the Research Ethics Board at the University of New Brunswick (REB: 2018–168).Trial registration numberNCT03787836.


2019 ◽  
Vol 26 (2) ◽  
pp. 107-117
Author(s):  
Novita Intan Arovah ◽  
Bernadeta Maria Wara Kushartanti

Abstract Background and aims: This study investigate the effects of increases in moderate-vigorous physical activity (MVPA) on several clinical parameters in Indonesian type 2 diabetes mellitus (T2DM) patients. Material and methods: This study used clinical and physical activity data of forty-two T2DM patients who completed a 6 month-free-living physical activity program, the Walking with Diabetes Study. Upon completion of the program, participants were categorised into a group with increases in MVPA (the MVPA+ group, n=24) or a group with steady/decreases in MVPA (the control group, n=18). High density lipoprotein, triglyceride, routine hematology profiles, blood pressure, body mass index, weight/hip ratio and self-reported MVPA, at baseline, 3 and 6 months were retrospectively analysed. Generalized estimating equation adjusted for age and sex were conducted to assess group and time effects on the clinical parameters. Results: Hemoglobin (p <0.01), erythrocytes (p<0.05), hematocrits (p<0.001) and thrombocytes (p<0.05) were higher in the MVPA+ group. The 1h and 2h-erythrocyte sedimentation rate (ESR) increased in both groups across time (p<0.001). No changes between groups across time were found for other parameters. Conclusions: Increases in MVPA improve several hematology parameters in T2DM patients, but it does not have protective effects in controlling systemic inflammation in T2DM patients.


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