Multi-domain intervention for prevention of cognitive decline among older adults with mild cognitive impairment: A cluster randomized trial protocol (TINAGE trial)

With global demographic shifts leading to an increasingly aging population, the prevalence of cognitive decline, including mild cognitive impairment (MCI), is on the rise. Despite significant research efforts, effective interventions for preventing cognitive decline and dementia remain limited. This study aims to investigate the effects of a 2-year multidomain intervention on cognition in community-dwelling older adults above 60 years with mild cognitive impairment. A two-arm cluster randomized trial will be conducted among older adults aged 60-75 years with MCI. The eligible participants will be identified through house-to-house visits in the selected wards (20 wards) of Tiruvalla taluk. Identified, consented adults will be screened using a validated tool. The 20 wards will be randomly divided into two arms: intervention and control. Among those diagnosed with MCI, 21 individuals from each ward will be randomly enrolled in the study. The multidomain intervention includes nutrition, physical activity, social support and engagement, cognitive stimulation training, and management of metabolic and vascular risk factors. Approval from the Institutional Review Board (IRB) has been obtained (IEC Study Number: IEC/2022/08/279. Trial has been registered in CTRI, CTRI registration number: CTRI/2023/11/060181. The cluster randomized trial will investigate the effectiveness of a culturally adapted multidomain intervention in the prevention of cognitive decline among older adults with mild cognitive impairment. If found effective can be scaled to similar settings.