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

BMJ open
January 1, 1970
Kaushik Chattopadhyay et al. (14 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine the feasibility of a Yoga programme (including Pranayama Breathing) for preventing type-2 diabetes among high-risk individuals in India.

Results Summary

The study assessed feasibility parameters for a larger RCT but did not report specific outcomes for Pranayama Breathing alone. The intervention included Pranayama as part of a broader Yoga programme aimed at T2DM prevention.

Population

Adults aged 18-74 years at high risk of type-2 diabetes (fasting plasma glucose level 5.6-6.9 mmol/L) in India.

Effective Dosage

Not specified (part of a structured Yoga programme).

Duration

6 months.

Interactions

None mentioned.

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Physical activity and a healthy diet (healthy lifestyle)
decrease
blood glucose levels
people at high risk of T2DM
-
improve
#1
Yoga programme for T2DM prevention (YOGA-DP)
decrease
T2DM
high risk people in India
-
can help to prevent
#2
YOGA-DP
decrease
T2DM
high risk people in India
-
is effective in preventing
#3
Abstract

INTRODUCTION: A 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. INTERVENTION: YOGA-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 ANALYSIS: This 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 DISSEMINATION: Ethics 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 NUMBER: CTRI/2019/05/018893.

Medical Subject Headings (MeSH)
AdolescentAdultAgedDiabetes Mellitus, Type 2Feasibility StudiesHumansIndiaMeditationMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicYogaYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations8
Citations/Year1.6
Relative Citation Ratio0.82
NIH Percentile42.8%
Research Impact Scores
APT Score0.75
Weight Score1.69
Normalized Score0.67
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