Effects of combining positive psychological intervention and lifestyle intervention on improving cardiovascular health for at-risk older adults: study protocol of a Chinese multicentric community-based randomised controlled trial (ACCOMPLI-CH).

INTRODUCTION

Cardiovascular health is influenced by various factors, including not only physiological and behavioural ones but also psychological well-being. However, when developing comprehensive preventive approaches, psychological interventions often receive less attention, despite their possible multiple mechanisms on cardiovascular health. Incorporating both healthy behaviour and psychological well-being promotion would be a more efficacious preventive approach. This study aims to investigate the effects of a community-based multicomponent intervention combining positive psychological intervention and lifestyle intervention on improving cardiovascular health among older adults with risk factors of cardiovascular diseases.

METHODS AND ANALYSIS

This study is a multicentre, community-based, randomised controlled trial with 18 months of intervention and follow-up for community-dwelling older adults aged 60 years and above with risk factors for cardiovascular health. Intervention activities last 6 months and are composed of in-person group training sessions of 60-80 min led by trained group instructors and weekly self-monitoring homework. Participants are randomly assigned to a multicomponent intervention 'Harmony' group (24 sessions of positive psychology and lifestyle intervention delivered weekly), an active control 'Lifestyle' group (eight sessions of lifestyle intervention delivered every 3-4 weeks) or a waitlist control group (no intervention activities). Positive psychological training sessions are designed using well-known techniques derived from positive psychology theories with adaptations to Chinese culture, and lifestyle training sessions are developed according to national guidelines. The primary outcome includes the change of a composite score of systolic blood pressure, total cholesterol, high-density lipoprotein and low-density lipoprotein levels, as well as psychological well-being measured from three perspectives, including hedonic, eudaimonic and evaluative well-being. Secondary assessments include other measures for physical and biological indicators, psychological well-being, health behaviours, social connection factors and overall cognitive functions. Primary data analyses will follow the intention-to-treat principle. To examine the effects of intervention, multilevel mixed models will be performed. In case of any differences in baseline participant characteristics, they will be adjusted for as covariates.

ETHICS AND DISSEMINATION

A centralised ethics review process was conducted, and the study protocol was approved by the ethics committee of the Institutional Review Board of the Institute of Psychology, Chinese Academy of Sciences in April 2022. A signed written informed consent form will be obtained from all participants. On completion, the trial results will be disseminated through published manuscripts and presentations at scientific conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2200062929.