Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP): A Qualitative Study Exploring the Trial Team's Facilitators and Challenges in Conducting a Feasibility Trial in India.

BACKGROUND: In India, around 77 million people are at high risk of developing type 2 diabetes mellitus (T2DM). Yoga interventions can be effective in preventing T2DM. We conducted a feasibility randomized controlled trial (RCT) in India, and the intervention was the Yoga Programme for T2DM Prevention (YOGA-DP). This study aimed to identify and explore the facilitators and challenges in conducting the feasibility trial in India, and more specifically, to explore the perceptions and experiences of trial staff in relation to running the feasibility trial and Yoga instructors in relation to delivering the intervention. METHODS: An exploratory qualitative study was conducted at two trial sites in India (Yoga centers in New Delhi and Bengaluru). Semi-structured interviews were conducted with ten participants (six trial staff and four Yoga instructors) to explore their perceptions and experiences related to the study's aim. Data were analyzed using deductive as well as inductive logic and an interpretative phenomenological approach. RESULTS: Feasibility-trial-related facilitators were useful participant recruitment strategies and help and support received from the trial coordination center. Intervention-related facilitators were strengths of the intervention content, structure, and delivery (including materials) and competencies of Yoga instructors. Feasibility-trial-related challenges were lack of awareness about T2DM among potential participants, stigma and fear associated with T2DM among potential participants, difficulties in explaining the research and obtaining written informed consent from potential participants, expectations and demands of potential participants and control-group participants, gender and language issues in participant recruitment, other participant recruitment-related challenges, issues in participant follow-up, and issues in data collection and trial documentation. Intervention-related challenges were the limited interest of participants in Yoga, participants' time constraints on practicing Yoga, participants' health issues hindered Yoga practice, beginners' difficulties with practicing Yoga, participants' demotivation to practice Yoga at home, issues with the Yoga practice venue, confusion regarding the intervention structure, issues with intervention materials, and the incompetence of Yoga instructors. CONCLUSIONS: The perceptions and experiences of trial staff and Yoga instructors helped us to understand the facilitators and challenges in running a feasibility trial and delivering the intervention for T2DM prevention, respectively. These findings and their suggestions will be used when designing the definitive RCT for evaluating YOGA-DP's effectiveness, and may be helpful to researchers planning similar trials. TRIAL REGISTRATION NUMBER: India (CTRI) CTRI/2019/05/018893.

Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People in India: A Multicenter Feasibility Randomized Controlled Trial.

INTRODUCTION: Many Indians are at high risk of type 2 diabetes mellitus (T2DM). The blood glucose level can be improved through a healthy lifestyle (such as physical activity and a healthy diet). Yoga can help in T2DM prevention, being a culturally appropriate approach to improving lifestyle. We developed the Yoga Programme for T2DM Prevention (YOGA-DP), a 24-week structured lifestyle education and exercise (Yoga) program that included 27 group Yoga sessions and self-practice of Yoga at home. In this study, the feasibility of undertaking a definitive randomized controlled trial (RCT) was explored that will evaluate the intervention's effectiveness among high-risk individuals in India. METHODS: A multicenter, two-arm, parallel-group, feasibility RCT was conducted in India. The outcome assessors and data analysts were blinded. Adults with a fasting blood glucose level of 100-125 mg/dL (i.e., at high risk of T2DM) were eligible. Participants were randomized centrally using a computer-generated randomization schedule. In the intervention group, participants received YOGA-DP. In the control group, participants received enhanced standard care. RESULTS: In this feasibility trial, the recruitment of participants took 4 months (from May to September 2019). We screened 711 people and assessed 160 for eligibility. Sixty-five participants (33 in the intervention group and 32 in the control group) were randomized, and 57 (88%) participants were followed up for 6 months (32 in the intervention group and 25 in the control group). In the intervention group, the group Yoga sessions were continuously attended by 32 (97%) participants (median (interquartile range, IQR) number of sessions attended = 27 (3)). In the intervention group, Yoga was self-practiced at home by 30 (91%) participants (median (IQR) number of days per week and minutes per day self-practiced = 2 (2) and 35 (15), respectively). In the control group, one (3%) participant attended external Yoga sessions (on Pranayama) for 1 week during the feasibility trial period. There was no serious adverse event. CONCLUSIONS: The participant recruitment and follow-up and adherence to the intervention were promising in this feasibility study. In the control group, the potential contamination was low. Therefore, it should be feasible to undertake a definitive RCT in the future that will evaluate YOGA-DP's effectiveness among high-risk people in India. FEASIBILITY TRIAL REGISTRATION: Clinical Trials Registry-India (CTRI) CTRI/2019/05/018893; registered on May 1, 2019.

Feasibility Trial of Yoga Programme for Type 2 Diabetes Prevention (YOGA-DP) among High-Risk People in India: A Qualitative Study to Explore Participants' Trial- and Intervention-Related Barriers and Facilitators.

Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga programme for T2DM prevention (YOGA-DP) and conducted a feasibility randomised controlled trial (RCT) among high-risk people in India. This qualitative study's objective was to identify and explore participants' trial- and intervention-related barriers and facilitators. The feasibility trial was conducted at two Yoga centres in New Delhi and Bengaluru, India. In this qualitative study, 25 trial participants (13 intervention group, 12 control group) were recruited for semi-structured interviews. Data were analysed using deductive logic and an interpretative phenomenological approach. Amongst intervention and control participants, key barriers to trial participation were inadequate information about recruitment and randomisation processes and the negative influence of non-participants. Free blood tests to aid T2DM prevention, site staff's friendly behaviour and friends' positive influence facilitated trial participation. Amongst intervention participants, readability and understanding of the programme booklets, dislike of the Yoga diary, poor quality Yoga mats, difficulty in using the programme video, household commitment during home sessions, unplanned travel, difficulty in practising Yoga poses, hesitation in attending programme sessions with the YOGA-DP instructor of the opposite sex and mixed-sex group programme sessions were key barriers to intervention participation. Adequate information was provided on T2DM prevention and self-care, good venue and other support provided for programme sessions, YOGA-DP instructors' positive behaviour and improvements in physical and mental well-being facilitated intervention participation. In conclusion, we identified and explored participants' trial- and intervention-related barriers and facilitators. We identified an almost equal number of barriers (n = 12) and facilitators (n = 13); however, intervention-related barriers and facilitators were greater than for participating in the trial. These findings will inform the design of the planned definitive RCT design and intervention and can also be used to design other Yoga interventions and RCTs.

Yoga Program for Type 2 Diabetes Prevention (YOGA-DP) Among High-Risk People: Qualitative Study to Explore Reasons for Non-participation in a Feasibility Randomized Controlled Trial in India.

Background: Yoga-based interventions can be effective in preventing type 2 diabetes mellitus (T2DM). We developed a Yoga program for T2DM prevention (YOGA-DP) among high-risk people and conducted a feasibility randomized controlled trial (RCT) in India. The objective of this study was to identify and explore why potential participants declined to participate in the feasibility RCT. Methods: An exploratory qualitative study, using semi-structured interviews, was conducted at a Yoga center in New Delhi, India. Fourteen people (10 women and four men) who declined to participate in the feasibility RCT were interviewed, and 13 of them completed the non-participant questionnaire, which captured their socio-demographics, diets, physical activities, and reasons for declining. Results: Three types of barriers were identified and explored which prevented participation in the feasibility RCT: (1) personal barriers, such as lack of time, perceived sufficiency of knowledge, preferences about self-management of health, and trust in other traditional and alternative therapies; (2) contextual barriers, such as social influences and lack of awareness about preventive care; and (3) study-related barriers, such as lack of study information, poor accessibility to the Yoga site, and lack of trust in the study methods and intervention. Conclusions: We identified and explored personal, contextual, and study-related barriers to participation in a feasibility RCT in India. The findings will help to address recruitment challenges in future Yoga and other RCTs. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: CTRI/2019/05/018893.

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

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.