The Hans Kai Trial: Study Protocol of a Mixed Methods Randomized Controlled Trial Evaluating a Peer-led Health Promotion Program for Adults with or without Chronic Health Conditions

Abstract Background. Recent research has shown that the COVID-19 pandemic has caused a significant increase in physical and mental health problems reported by adults worldwide, which may be addressed by peer-led interventions that focus on promoting health and reducing isolation or loneliness. To date, evaluation studies that have assessed the effectiveness of these programs have shown mixed results. The Hans Kai trial described here aims to evaluate the efficacy of the peer-led health promotion Hans Kai program in supporting the health and wellbeing of its participants and investigate the experiences of the Hans Kai participants and facilitators. Methods. This research will involve a mixed methods trial combining an experimental component with a qualitative component. The experimental component will involve a randomized controlled trial (RCT) with an appropriate control group, randomization of participants to conditions, and a focus on the impact of the program on several health indicators. The qualitative component will investigate the experiences of program participants and facilitators to identify the main strengths and limitations of Hans Kai, uncover potential implementation issues, and elucidate the mechanisms through which the program works. The population of interest will include adults aged 18 + with or without chronic health conditions who are interested in taking control of their own health and improving their lifestyle. In the RCT, all outcomes of interest will be measured using a multi-method approach, involving self-report questionnaires and objective (direct) indicators. The qualitative component of the RCT will also involve a multi-method approach in which multiple qualitative data collection methods will be used to reach a deeper and more nuanced understanding of the program strengths, how the program works, and for which people it is more effective in promoting health and wellbeing. Adaptable components of the program will also be investigated and modified according to the feedback provided by the RCT participants. Discussion. The RCT findings will help support the further development and use of Hans Kai as well as other peer-led health promotion interventions. Trial Registration. United Stated Clinical Trial Registry Clinicaltrials.gov (registration# NCT03949725; Protocol version 2, June 22nd, 2022).