Effectiveness of a 52-week multidomain intervention to maintain cognitive function in patients with mild cognitive impairment: a randomized controlled trial

Mild cognitive impairment (MCI) increases the risk of dementia. Reducing modifiable lifestyle-related risk factors can help prevent cognitive decline in patients with MCI. We examined whether a multidomain intervention using a mobile application can prevent cognitive decline in patients with MCI. The trial is designed in accordance with the CONSORT Statement. We conducted an assessor-blind, randomized controlled trial. Patients with MCI, aged over 60 years and presenting with at least one modifiable risk factor for dementia, were recruited from three dementia centers in Gangwon-do, Korea, and outpatient clinics at Chuncheon Sacred Heart Hospital. Participants were randomly assigned to either the intervention group or the control group in a 1:1 ratio. Each participant received a 52-week intervention. The intervention group used a mobile application to manage their diet and physical activity at least three times per week, while the control group received general dietary and physical activity recommendations twice a year. The primary outcome was the change in cognitive function measured based on the mini-mental state examination in the Korean version of the CERAD assessment packet (MMSE-KC) score. Between October 2020 and September 2021, 84 people were screened, and 80 participants were randomly assigned to either the control or intervention group (intervention group = 42, control group = 38). Participants in both groups underwent a post-baseline assessment and their data were included in the analysis. We found a positive effect of the multidomain intervention using a mobile application on the change in cognitive function score in the intervention group compared to the control group at the 52-week follow-up. The MMSE-KC (F = 10.6, p < .001) and modified Boston Naming test (F = 8.3, p < .01) scores were significantly higher in the intervention group than in the control group. The results suggest that a multidomain mobile application intervention could help improve cognition in patients with MCI.The study protocol was prospectively registered with the Clinical Research Information Service (CRIS, Republic of Korea; KCT0008315) on March 16, 2023. The full trial details can be accessed at https://cris.nih.go.kr/cris/search/detailSearch.do?seq=22920 .