scholarly journals The ProActivetrial protocol – a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766]

2004 ◽  
Vol 4 (1) ◽  
Author(s):  
Kate Williams ◽  
A Toby Prevost ◽  
Simon Griffin ◽  
Wendy Hardeman ◽  
William Hollingworth ◽  
...  
Keyword(s):  
Physical Activity ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Programme ◽  
Family Based ◽  
Randomised Controlled

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 Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol

2019 ◽  
Vol 6 (1) ◽  
pp. 23
Author(s):  
Hosam Alzahrani ◽  
Martin Mackey ◽  
Emmanuel Stamatakis ◽  
Marina B. Pinheiro ◽  
Debra Shirley
Keyword(s):  
Physical Activity ◽  
Low Back Pain ◽  
Back Pain ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Intervention Program ◽  
Controlled Trial ◽  
Low Back ◽  
Walking Intervention ◽  
Randomised Controlled

<p> </p><p class="abstract"><strong>Background:</strong> The lifetime prevalence of low back pain (LBP) has been reported to be as high as 84% worldwide. Around 23% of the population has chronic non-specific LBP. Despite the potential health benefits of walking, few studies have investigated its effectiveness in people with non-specific LBP. The primary objective is to examine the efficacy of a Fitbit facilitated walking intervention in people with LBP with medium or high risk of chronicity in reducing disability and pain. The secondary objective is to investigate the efficacy of a Fitbit facilitated walking intervention in increasing physical activity levels in people with LBP.</p><p class="abstract"><strong>Methods:</strong> This prospective, randomised controlled trial<strong> </strong>will involve 68 participants. This study will recruit participants who are aged 18 years or over, have been diagnosed with non-specific LBP with medium or high risk of chronicity and classified as physically inactive. Participants will be randomised into two groups: usual physiotherapy care (n=34) and usual physiotherapy care plus Fitbit facilitated walking intervention program (n=34). The treatment duration will be 8 weeks. Primary outcomes for this study are disability and pain. Secondary outcomes include physical activity level and walking steps, depression, fear of movement and pain catastrophising. The outcomes will be assessed at baseline, post-intervention and 26 weeks post-randomisation follow-up.</p><p class="abstract"><strong>Conclusions:</strong> The results of this study will provide empirical evidence on the efficacy of a Fitbit facilitated walking intervention program, when added to usual care, in a clinical setting for improving disability and pain, and other clinical outcomes in people with LBP.</p><p class="abstract"><strong>Trial Registration: </strong>Australian New Zealand clinical trials registry (Number ACTRN12617001404314).</p>

scholarly journals Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017908 ◽  
Author(s):  
Stanley Sai-Chuen Hui ◽  
Yao Jie Xie ◽  
Ron Chi-Wai Kwok ◽  
Eric Wing-Cheung Tam ◽  
Winnie Wing Sze Mak ◽  
...  
Keyword(s):  
Physical Activity ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Middle Aged ◽  
Intervention Programme ◽  
Study Results ◽  
Randomised Controlled

IntroductionHong Kong is a highly urbanised city where many people work long hours. The limited time and lack of professional instruction are the typical barriers to exercise. The purpose of this study is to test the effectiveness of an information technology-based lifestyle intervention programme on improving physical activity (PA) level and health status in a sample of middle-aged Hong Kong adults.Methods and analysisA two-arm parallel randomised controlled trial named ‘Follow Your Virtual Trainer’ will be conducted among 200 physically inactive Chinese adults aged from 40 to 65 years. Those randomly allocated to an intervention group will be under the instruction of a web-based computer software termed ‘Virtual Trainer (VT)’ to conduct a 3-month self-planned PA programme. A series of online seminars with healthy lifestyle information will be released to the participants biweekly for 3 months. After that, 6 months observation will follow. Those in the control group will only receive a written advice of standard PA recommendation and the textual content of the seminars. The assessments will be implemented at baseline, the 3rd, 6th and 9th months. The primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire. The secondary outcomes include cardiorespiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behaviour mediators and maintenance of PA. The main effectiveness of the intervention will be assessed by a linear mixed model that tests the random effect of treatment on outcomes at the 3rd, 6th and 9th months.Ethics and disseminationThis trial has been approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (CRE 2015235). The study results will be presented at scientific conferences and published in peer-reviewed journals.Trial registration numberNCT02553980.

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