A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention Among High Risk Individual: Study Protocol (the Mydipp Trial)

2020 ◽  
Author(s):  
Nurul Fatihah Mohd Fauzi ◽  
Sharifah Wajihah Wafa ◽  
Naresh Bhaskar Raj ◽  
Mohd Ibrahim Abdullah ◽  
Barakatun Nisak Mohd Yusof ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Parallel Group ◽  
Randomised Controlled

Abstract Background: Approximately 37% of the individuals with prediabetes will have diabetes in four years if they do not change their lifestyle through any intervention. Lifestyle modification intervention has shown to be effective in reducing or delaying the onset of type 2 diabetes mellitus (T2DM) among high-risk individuals. Some intervention approaches integrate human coaching into technology using phone or email to enable wider reach, known as digital therapy. It is considered as a scalable method to reach a larger population who are at risk, convenient and accessible. This study aims to determine the feasibility and efficacy of lifestyle intervention to prevent type 2 diabetes among adults who are at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the Malaysia Diabetes Prevention Programme (MyDiPP) app.Methods: ‘MyDiPP’ is a 12-month lifestyle intervention digital therapy with multiple approaches (weight loss, dietary modification, physical activity and quality of life). Eligible adults are aged 18-65 years, overweight/obese (BMI ≥ 23 kgm2) and athigh-risk for type2diabetes (American Diabetes Association(ADA) Diabetes Risk Score ≥ 5, or HbA1c of 5.6-6.2%). Each participant will be randomly assigned to one oftwo study groups in 1:1 ratio using simple randomisation to intervention or usual care control groups. The primary outcome is the change in weight at 6 months and 12 months, while the secondary outcomes are changes in HbA1c level, physical activity level, dietary intake and quality of life. The MyDiPP programme is an assessor-blinded, parallel-group, randomised controlled trial, in which the app consists of educational lessons, group, technology-enabled discussions, tools to track nutritional intake, physical activity, body weight and blood glucose level as well as platform to communicate with the health coaches. Discussion: This study is necessary to determine to what extent the intervention programme reduces risks of diabetes risk in comparison to the usual care.Trial registration details:This trial was prospectively registered with Clinical Trial Registry (CTR) on 21st June 2019 with trial registration number NCT03997656.

scholarly journals Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025578
Author(s):  
Leigh Hale ◽  
Tim Stokes ◽  
Bonnie Scarth ◽  
Ramakrishnan Mani ◽  
Trudy Sullivan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Education Programme ◽  
Secondary Outcome ◽  
Randomised Controlled

IntroductionType 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in deprived areas. We have previously demonstrated the feasibility and acceptability of the DCEP. This study aims to determine the effectiveness and cost-effectiveness of the DCEP through a pragmatic randomised controlled trial (RCT).Methods and analysis220 adults (age ≥35 years) with type 2 diabetes will be recruited from general practices in the lower South Island of NZ (Dunedin and Invercargill) to participate in an RCT. Participants will be randomised to intervention (DCEP) and control (usual care) groups. The DCEP participants will have their exercise goals agreed on with a physiotherapist and nurse and will attend two 90 min exercise and education sessions per week for 12 weeks. The primary outcome measure is blood glucose control (glycated haemoglobin). Secondary outcome measures include quality of life assessed using the Audit of Diabetes-Dependent Quality of Life questionnaire. Data will be collected at four time points: baseline, end of the 12-week intervention (3 months), 6 months postintervention (9 months) and 12 months after the intervention ends (15 months). We will also conduct a cost-effectiveness analysis and a qualitative process evaluation.Ethics and disseminationThe study has been approved by the Health and Disability Ethics Committee, Ministry of Health (HDEC17/CEN/241/AM01). A key output will be the development of an evidence-based training package to facilitate implementation of the DCEP in other NZ regions.Trial registration numberACTRN 12617001624370 p; Pre-results.

scholarly journals Pilot Randomised Evaluation of Singing in Dementia (PRESIDE): protocol for a two-arm, parallel-group randomised controlled feasibility study with waiting-list control

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Becky Dowson ◽  
Justine Schneider ◽  
Boliang Guo ◽  
Philip M. Bath ◽  
Orii McDermott ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Waiting List ◽  
Community Group ◽  
People With Dementia ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Person With Dementia

Abstract Background As the number of people living with dementia grows, so does the need to provide them with adequate psychosocial support. Many people with dementia live at home with family carers, who also require social and emotional support to cope with their role. Community group singing has received attention for its potential to support people with dementia and their carers. It is postulated that singing can improve cognitive function, strengthen the bonds between care partners and help to establish social support networks. However, there is a lack of rigorous evidence of singing’s benefits for this population. This study aims to test the feasibility of a randomised controlled trial of community singing in dementia, to pave the way for a larger, conclusive study. Methods The PRESIDE study is designed as a two-arm, parallel-group randomised trial with a waiting list control. Dyads consisting of a person with dementia (n = 80) and their carer (n = 80) will be recruited. Each dyad will be randomised either to attend 10 weeks of community group singing sessions straight away or to wait for 3 months before attending the sessions. The singing sessions will be led by experienced professional musicians and will last about 90 min, including time for socialising. The primary outcome of this study is the attainment of feasibility criteria around recruitment, retention and the acceptability of the waiting list control. Secondary outcomes include the quality of life, mood, cognition, and musical engagement of the person with dementia, and quality of life, mood, and experiences/challenges of the carer. These data will be collected during home visits at baseline, and 3 and 6 months post-baseline. Discussion Despite growing public interest in the positive effects of singing, and encouraging findings from qualitative and non-randomised quantitative studies, there is a lack of rigorous evidence. This is the first randomised controlled trial of community group singing for people with dementia in Europe, to our knowledge. If the results favour a full trial, conclusively demonstrating the effectiveness of group singing could positively affect the opportunities available to community-dwelling people with dementia and their carers. Trial registration Unique identification number in ISRCTN registry: ISRCTN10201482. Date registered: 12 May 2020

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.

The impact of physical activity on fatigue and quality of life in lung cancer patients: A randomised controlled trial (RCT).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 9507-9507 ◽  
Author(s):  
Janette L. Vardy ◽  
Melanie Bell ◽  
Hidde van der Ploeg ◽  
Jane Turner ◽  
Michael Kabourakis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Lung Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Lung Cancer Patients ◽  
Randomised Controlled ◽  
The Impact
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