scholarly journals Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Kristina Larsson ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Randomised Controlled ◽  
Step Study

Abstract Background This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. Methods The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. Results In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. Conclusion This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015—Retrospectively registered.

scholarly journals Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
Barbara Ainsworth ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Care ◽  
Intervention Group ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Component Group ◽  
The Mean ◽  
Step Study

Abstract Background Describing implementation features of an intervention is required to compare interventions and to inform policy and best practice. The aim of this study was to conduct a process evaluation of the first 12 months of the Sophia Step Study: a primary care based RCT evaluating a multicomponent (self-monitoring of daily steps plus counseling) and a single component (self-monitoring of steps only) physical activity intervention to standard care on cardiometabolic health. Methods The evaluation was guided by the Medical Research Council Guidance for complex interventions. To describe the implementation communication with the health professionals implementing the interventions, attendance records and tracking of days with self-monitored pedometer-determined steps were used. Change in physical activity behaviour was measured at baseline, 6 and 12 months as daily steps by accelerometry. Results During April 2013 to January 2018 188 participants were randomized and intervened directly after inclusion. Response rate was 49% and drop out was 10%. A majority, 78%, had type 2 diabetes and 22% were diagnosed with prediabetes. Mean [Standard deviation (SD)] body mass index was 30.4 (4.4) kg/m2 and steps per day was 6566 (3086). The interventions were delivered as intended with minor deviation from the protocol and dose received was satisfying for both the multicomponent and single component group. The mean [95% Confidence Interval (CI)] change in daily steps from baseline to 6 months was 941(227, 1655) steps/day for the multicomponent intervention group, 990 (145, 1836) step/day for the single component group and − 506 (− 1118, 107) for the control group. The mean (95% CI) change in daily steps from baseline to 12 months was 31(− 507, 570) steps/day for the multicomponent intervention group, 144 (− 566, 853) step/day for the single component group and − 890 (− 1485, − 294) for the control group. There was a large individual variation in daily steps at baseline as well as in step change in all three groups. Conclusions Applying self-monitoring of steps is a feasible method to implement as support for physical activity in the primary care setting both with and without counseling support. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015.

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

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.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Salud paso por paso : a culturally-tailored physical activity intervention with hispanic adults with type 2 diabetes mellitus

2021 ◽  
Author(s):  
◽  
Julio Cesar Loya
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Tailored ◽  
Hispanic Adults

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.

scholarly journals Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036277 ◽  
Author(s):  
Kaushik Chattopadhyay ◽  
Pallavi Mishra ◽  
Kavita Singh ◽  
Tess Harris ◽  
Mark Hamer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Plasma Glucose ◽  
Plasma Glucose Level ◽  
Controlled Trial ◽  
Randomised Controlled

IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.InterventionYOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.Methods and analysisThis is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18–74 years, at high risk of T2DM (fasting plasma glucose level 5.6–6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20–30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.Ethics and disseminationEthics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration numberCTRI/2019/05/018893.

scholarly journals Qatar Diabetes Mobile Application Trial (QDMAT): An Open-Label Randomised Controlled Trial To Examine The Impact of Using A Mobile Application To Improve Diabetes Care In Type 2 Diabetes Mellitus – A Study Protocol

2021 ◽  
Author(s):  
Noor Suleiman ◽  
Meis Alkasem ◽  
Zaina Al Amer ◽  
Obada Salameh ◽  
Noora Al-Thani ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Mobile Application ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Management ◽  
Open Label ◽  
Randomised Controlled

Abstract BackgroundMobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with diabetes. A new mobile application was specifically built for people with diabetes with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile App.MethodsThe planned study is an ongoing open-label randomised controlled trial in which insulin-treated adults with type 2 diabetes mellitus (T2DM) will be randomised 1:1 to the use of this diabetes application versus current standard care. The primary outcome will be the difference in mean HbA1c from baseline at 6 months. Other outcome measures include anthropometric measures, hypoglycaemic events, medication adjustments, number of clinical interactions and missed appointments, and patient perceptions of their disease and diabetes self-management. The study will randomise 180 subjects ( for assessment of the primary outcome. DiscussionWe hypothesise that the diabetes-specific mobile application will improve glycaemic control, increase patient empowerment for self-management of diabetes and improve interaction between patients and healthcare providers. If QDMAT demonstrates this, it will inform clinical services for the future self-management of T2DM.Trial Registration,ClinicalTrials.gov Identifier: NCT03998267) Registered on 26 June 2019

scholarly journals Walking with Diabetes (WW-DIAB) programme a walking programme for Indonesian type 2 diabetes mellitus patients: A pilot randomised controlled trial

2018 ◽  
Vol 6 ◽  
pp. 205031211881439
Author(s):  
Novita Intan Arovah ◽  
Bernadeta Margareta Wara Kushartanti ◽  
Tracy L Washington ◽  
Kristiann C Heesch
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Controlled Trial ◽  
Text Message ◽  
Related Quality ◽  
Randomised Controlled ◽  
Walking Programme

Objectives: This pilot study aimed to examine the feasibility and effectiveness of a pedometer-based walking programme in Indonesian type 2 diabetes mellitus patients. Methods: Feasibility was assessed by monitoring participant recruitment, retention, and adherence to the step-monitoring and recording instructions. Effectiveness was assessed in a pilot randomised controlled trial. Participants were type 2 diabetes mellitus patients randomly assigned to a pedometer-only (PED-only) group (n = 22) and a pedometer with text message support (PED+) group (n = 21). Outcomes were step counts, self-reported physical activity, social cognitive constructs, glycaemic parameters, and health-related quality of life. These were assessed at baseline, 12-week intervention, and 12 weeks later. Longitudinal analyses using generalised estimating equations were carried out to assess treatment and time effects on study outcomes. Results: All but one participant (98%) attended 12- and 24-week data collection follow-ups. Throughout the study period, 82% of PED+ participants submitted their daily steps log. Daily steps increased in both groups (p < 0.001) but more in the PED+ group (2064 more steps at week 24, 95% confidence interval: 200–3925, p = 0.03). Self-reported physical activity levels and glycaemic parameters increased similarly in the two groups over time (p < 0.05). Improvements in social cognitive processes were seen only in the PED+ group (p < 0.05). There were no significant improvements in health-related quality of life. Conclusion: This study provides preliminary evidence that a pedometer-based walking programme, with or without additional support, is feasible and improves physical activity and glucose levels in Indonesian type 2 diabetes mellitus patients. Greater increases in step counts can result from the provision of text message support and education materials than from the provision of a pedometer only.

A randomised, controlled trial of self-monitoring of blood glucose in patients with type 2 diabetes receiving conventional insulin treatment

Diabetologia ◽  
2014 ◽  
Vol 57 (5) ◽  
pp. 868-877 ◽  
Author(s):  
Michael A. Nauck ◽  
◽  
Burkhard Haastert ◽  
Christoph Trautner ◽  
Ulrich A. Müller ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Randomised Controlled Trial ◽  
Insulin Treatment ◽  
Controlled Trial ◽  
Self Monitoring ◽  
Randomised Controlled
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