PMID- 37561266 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240320 IS - 1869-6953 (Print) IS - 1869-6961 (Electronic) IS - 1869-6961 (Linking) VI - 14 IP - 10 DP - 2023 Oct TI - 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. PG - 1695-1709 LID - 10.1007/s13300-023-01450-0 [doi] AB - 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. CI - (c) 2023. The Author(s). FAU - Mishra, Pallavi AU - Mishra P AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Greenfield, Sheila Margaret AU - Greenfield SM AD - Institute of Applied Health Research, University of Birmingham, Birmingham, UK. FAU - Harris, Tess AU - Harris T AD - Population Health Research Institute, St. George's University of London, London, UK. FAU - Hamer, Mark AU - Hamer M AD - Division of Surgery and Interventional Science, Institute Sport, Exercise and Health, University College London, London, UK. FAU - Lewis, Sarah Anne AU - Lewis SA AD - Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, UK. FAU - Singh, Kavita AU - Singh K AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Nair, Rukamani AU - Nair R AD - Bapu Nature Cure Hospital and Yogashram, New Delhi, India. FAU - Mukherjee, Somnath AU - Mukherjee S AD - Bapu Nature Cure Hospital and Yogashram, New Delhi, India. FAU - Tandon, Nikhil AU - Tandon N AD - Department of Endocrinology, Metabolism and Diabetes, All India Institute of Medical Sciences, New Delhi, India. FAU - Kinra, Sanjay AU - Kinra S AD - Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. FAU - Manjunath, Nandi Krishnamurthy AU - Manjunath NK AD - Swami Vivekananda Yoga Anusandhana Samsthana, Bangalore, India. FAU - Prabhakaran, Dorairaj AU - Prabhakaran D AD - Centre for Chronic Disease Control, New Delhi, India. FAU - Chattopadhyay, Kaushik AU - Chattopadhyay K AUID- ORCID: 0000-0002-3235-8168 AD - Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, UK. Kaushik.Chattopadhyay@nottingham.ac.uk. LA - eng GR - MR/J000175/1/MRC_/Medical Research Council/United Kingdom GR - MR/R018278/1/MRC_/Medical Research Council/United Kingdom PT - Journal Article DEP - 20230810 PL - United States TA - Diabetes Ther JT - Diabetes therapy : research, treatment and education of diabetes and related disorders JID - 101539025 PMC - PMC10499709 OTO - NOTNLM OT - Challenges OT - Facilitators OT - Prediabetes OT - Qualitative research OT - Semi-structured interviews OT - Trial OT - Type 2 diabetes mellitus OT - Yoga COIS- The authors have nothing to disclose. EDAT- 2023/08/10 12:42 MHDA- 2023/08/10 12:43 PMCR- 2023/08/10 CRDT- 2023/08/10 11:16 PHST- 2023/05/25 00:00 [received] PHST- 2023/07/10 00:00 [accepted] PHST- 2023/08/10 12:43 [medline] PHST- 2023/08/10 12:42 [pubmed] PHST- 2023/08/10 11:16 [entrez] PHST- 2023/08/10 00:00 [pmc-release] AID - 10.1007/s13300-023-01450-0 [pii] AID - 1450 [pii] AID - 10.1007/s13300-023-01450-0 [doi] PST - ppublish SO - Diabetes Ther. 2023 Oct;14(10):1695-1709. doi: 10.1007/s13300-023-01450-0. Epub 2023 Aug 10.