Establishment and Evaluation of a Dietary Pattern Intervention on Changes in Cognitive Function in Elderly with Mild Cognitive Impairment and Dementia.

The overall purpose of this study is to establish and evaluate the efficacy of the Taiwanese Mediterranean diet intervention aimed at improving the cognitive function in community-dwelling elderly with mild cognitive impairment and mild dementia. The nutritional intervention has been developed based on the principles of the traditional Mediterranean diet, social cognitive theory, and behavioral change theory consisting 12 sessions, each about 2 hour long, in 12-week period. This study is a three-year project, divided into three phases: (1) the phase I is to conduct a systematic review and meta-analysis study to assess the effects of the nutritional interventions on cognitive functions of the elderly with mild cognitive impairment and mild dementia; (2) the phase II is to investigate the feasibility and acceptability of the proposed 12-week nutritional intervention for the elderly with mild cognitive impairment and mild dementia using mixed methods with quantitative surveys and qualitative data collected via a focus group; (3) the phase III is to implement the modified intervention based on the results from the phase II using a longitudinal, randomized controlled trial with quantitative surveys and qualitative data. A sample of 63 elderly with mild cognitive impairment, 63 elderly with mild dementia and 63 elderly with intact cognitive function in communities will be recruited. All the participants will be randomly assigned to the intervention group I (n=63), intervention group II (n=63) or to the control group (n=63).The allocation concealment and participant blinding will be performed. The evaluation of the effectiveness of the intervention on the elderly with mild cognitive impairment and mild dementia in the community will be conducted. Quantitative data will be collected at baseline (prior to intervention), at the end of intervention, 6 and 12 months after intervention, and a focus group with 10-15 participants in the group I will be undertaken 4 months after intervention. Outcome assessors will be blinded to treatment allocation. The results of this study would be as a guideline for community health care providers to offer older care and nutrition and health education, and then to improve older adult cognitive functions or prevent the decline in cognitive functions; in turn, improve care quality and elderly well-being. In addition, the results of this study should be the foundation to facilitate more precise policy-making of the promotion of cognitive health.