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

Abstract

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 Multicenter Feasibility Randomized Controlled Trial

“…Semi-structured qualitative interviews (as part of the qualitative process evaluation) were conducted with feasibility trial non-participants, participants, YOGA-DP instructors, and staff to explore trial- and intervention-related barriers and facilitators [ 28 , 51 , 52 ]. The findings will inform decisions on modifying the definitive RCT and intervention to further improve participation and adherence.…”

Experiences and perceptions of self‐management in people with prediabetes: A qualitative meta‐synthesis

“…At the same time, awareness of the dangers of diabetes further accelerated the process of changing their roles. Some participants (Duan et al, 2017; Hansen et al, 2011; Kuo et al, 2014; Li et al, 2015; Lim et al, 2020; Mishra et al, 2021; Strachan et al, 2018; Yoon et al, 2022) stated that the fear of the experiences of their family members who had been diagnosed with diabetes had prompted them to think about the dangerous state they were in and to think proactively about possible preventive measures.

…afraid because my aunt had her toe cut then she passed on. So when I think of her, I think that diabetes can kill, so how to prevent, how to control.

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“…Through the joint participation of family members, it can not only enhance the self‐management ability of people with prediabetes, but also provide psychological support and relieve the pressure brought by the disease. Participants in the included studies indicated that family members in their daily lives were the intrinsic motivation for them to control the development of disease, and the idea of not being a burden to the family pushed them to change the lifestyle (Andersson et al, 2008; Hansen et al, 2011; Howells et al, 2021; Mishra et al, 2021; Penn et al, 2008; Yoon et al, 2022).

If you become serious then amputation all these, it would affect your family life.

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Challenges to Recruiting Men on Active Surveillance for Prostate Cancer in Clinical Chemoprevention Trials

“…Since clinics were operating with reduced capacity and reduced in-person visits, recruiters were required to work virtually. Although other interventions (exercise, yoga) were administered via telemedicine [53,54], chemoprevention trials with a study drug under IND were not conducive to telemedicine interventions. With consistent evidence that clinical trials that enroll patients at proposed rates are critical to ensure internal validity and improve cancer mortality and morbidity, our goal is to recruit subjects in clinical trials efficiently and achieve our recruitment goals in a timely manner.…”