Multidomain Intervention Trial for Preventing Cognitive Decline among Older Adults with Type 2 Diabetes: J-MIND-Diabetes

Abstract

Background: No multidomain intervention trials have been designed for the prevention of cognitive decline in older adults with type 2 diabetes.

Objectives: To investigate the efficacy of a multidomain intervention in preventing cognitive decline in older adults with type 2 diabetes and cognitive impairment.

Design: Eighteen-month, multi-centered, randomized controlled trial.

Setting: Twelve hospitals in Japan.

Participants: Outpatients with type 2 diabetes aged 70-85 years with cognitive impairment.

Intervention: The multidomain intervention program includes management of metabolic and vascular risk factors, exercise, nutritional counseling, and promotion of social participation. Participants in the control group received usual care and treatment for type 2 diabetes.

Measurements: The primary outcome was the change in a composite score combining several neuropsychological tests from baseline to the 18-month follow-up. To assess the differences in cognitive changes between the intervention and control groups, a mixed-effects model for repeated measures was used.

Results: Between March 13, 2019, and May 8, 2020, 361 participants were screened, and 154 were randomly assigned to either the intervention group (n = 81) or the control group (n = 73). Finally, 110 participants completed the trial. The between-group difference in the composite score changes was 0.068 (95% confidence interval, -0.091 to 0.226). Analyses for secondary outcomes indicated a positive impact of the intervention on memory and indicated that the intervention led to changes in dietary habits with increased intakes of niacin and meat, along with weight reduction compared to the control group.

Conclusion: The multidomain intervention did not demonstrate efficacy in preventing cognitive decline. However, this trial provided proof-of-concept evidence that multidomain interventions may offer cognitive benefits and contribute to changes in dietary behavior and weight reduction in older adults with type 2 diabetes and cognitive impairment. These findings should be confirmed in future studies.

Keywords: Multidomain intervention; cognitive decline; diet; exercise; type 2 diabetes.

Figure 1

Trial profile MoCA-J, Japanese version of the Montreal Cognitive Assessment

Figure 2

Changes in composite scores (A) and delayed recall test scores of the ROCFT (B) from baseline to the 18-month follow-up *Mean difference in changes in delayed recall test scores of the ROCFT between the intervention and control groups was statistically significant (P < 0.05). ROCFT, Rey-Osterrieth Complex Figure Test

Figure 3

Changes in intakes of nutrients (A) and food groups (B) from baseline to 18-month follow-up The mean changes and the 95% confidence intervals within group were calculated using paired t-tests. The P-value for the mean differences between groups was calculated using the Wilcoxon rank sum test.