Nutrition Module design in Maintain Your Brain: an internet-based randomised controlled trial to prevent cognitive decline and dementia.

The Maintain Your Brain (MYB) trial is one of the largest internet-delivered multidomain randomised controlled trial designed to target modifiable risk factors for dementia. It comprises four intervention modules: physical activity, nutrition, mental health and cognitive training. This paper explains the MYB Nutrition Module, which is a fully online intervention promoting the adoption of the 'traditional' Mediterranean Diet (MedDiet) pattern for those participants reporting dietary intake that does not indicate adherence to a Mediterranean-type cuisine or those who have chronic diseases/risk factors for dementia known to benefit from this type of diet. Participants who were eligible for the Nutrition Module were assigned to one of the three diet streams: Main, Malnutrition and Alcohol group, according to their medical history and adherence to the MedDiet at baseline. A short dietary questionnaire was administered weekly during the first 10 weeks and then monthly during the 3-year follow-up to monitor whether participants adopted or maintained the MedDiet pattern during the intervention. As the Nutrition Module is a fully online intervention, resources that promoted self-efficacy, self-management and process of change were important elements to be included in the module development. The Nutrition Module is unique in that it is able to individualise the dietary advice according to both the medical and dietary history of each participant; the results from this unique intervention will contribute substantively to the evidence that links the Mediterranean-type diet with cognitive function and the prevention of dementia and will increase our understanding of the benefits of a MedDiet in a Western country.

Reliability and validity of a Mediterranean diet and culinary index (MediCul) tool in an older population with mild cognitive impairment.

Dementia is a leading cause of morbidity and mortality without pharmacologic prevention or cure. Mounting evidence suggests that adherence to a Mediterranean dietary pattern may slow cognitive decline, and is important to characterise in at-risk cohorts. Thus, we determined the reliability and validity of the Mediterranean Diet and Culinary Index (MediCul), a new tool, among community-dwelling individuals with mild cognitive impairment (MCI). A total of sixty-eight participants (66 % female) aged 75·9 (sd 6·6) years, from the Study of Mental and Resistance Training study MCI cohort, completed the fifty-item MediCul at two time points, followed by a 3-d food record (FR). MediCul test-retest reliability was assessed using intra-class correlation coefficients (ICC), Bland-Altman plots and κ agreement within seventeen dietary element categories. Validity was assessed against the FR using the Bland-Altman method and nutrient trends across MediCul score tertiles. The mean MediCul score was 54·6/100·0, with few participants reaching thresholds for key Mediterranean foods. MediCul had very good test-retest reliability (ICC=0·93, 95 % CI 0·884, 0·954, P<0·0001) with fair-to-almost-perfect agreement for classifying elements within the same category. Validity was moderate with no systematic bias between methods of measurement, according to the regression coefficient (y=-2·30+0·17x) (95 % CI -0·027, 0·358; P=0·091). MediCul over-estimated the mean FR score by 6 %, with limits of agreement being under- and over-estimated by 11 and 23 %, respectively. Nutrient trends were significantly associated with increased MediCul scoring, consistent with a Mediterranean pattern. MediCul provides reliable and moderately valid information about Mediterranean diet adherence among older individuals with MCI, with potential application in future studies assessing relationships between diet and cognitive function.

Electronic food records among middle-aged and older people: A comparison of self-reported and dietitian-assisted information.

AIM: Nutrition-based applications ("apps") offer enormous research potential, however evidence of their use and acceptability among older adults is limited. We compared self-reported and dietitian-adjusted dietary intake records among adults aged 55 to 75 years using the Research Food Diary (RFD) app. METHODS: Participants were recruited from the 45 and Up Study and completed a 3-day food record using the RFD. A follow-up dietetic telephone interview was performed to confirm the electronic dietary data. Independent of these interviews, a set of adjustments based on dietetic skills, nutritional database knowledge, food composition and dietary assessment was established to resolve probable reporting errors. The "adjusted" and "dietitian-assisted" records were compared to self-reported records for nutrient intakes and serves of The Five Food Groups using one-way repeated measures analysis of variance. RESULTS: Sixty-two participants were recruited, with 48 using the RFD app which included eight records without any identified errors. Reporting errors contained in the raw self-reported records included: food items with missing/implausible quantities or insufficient descriptions to allow automatic coding. After removal of unusable records, 44 records were analysed. Differences were found between the self-reported and adjusted records for protein, calcium, vitamin B12 , zinc and dairy food serves (all P < .001; differences up to 8%). No significant differences were found between the adjusted and dietitian-assisted measures. CONCLUSIONS: Similarities between adjusted and dietitian-assisted records suggest carefully applied dietetic assumptions are likely to improve accuracy of self-reported intake data where dietitian interviews are not possible. We provide four key recommendations to guide this process.

Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT: Maintain Your Brain Digital Platform.

Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.

Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline Among Community Dwelling 55 to 77 Year Olds.

BACKGROUND: Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort. METHODS: MYB aims to recruit 8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia. Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. MYB will run for three years and up to four modules will be delivered sequentially each quarter during year one. Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial. DISCUSSION: MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use.

Effect of the Mediterranean diet on cognition and brain morphology and function: a systematic review of randomized controlled trials.

Background: Observational studies of the Mediterranean diet suggest cognitive benefits, potentially reducing dementia risk. Objective: We performed the first published review to our knowledge of randomized controlled trials (RCTs) investigating Mediterranean diet effects on cognition or brain morphology and function, with an additional focus on intervention diet quality and its relation to "traditional" Mediterranean dietary patterns. Design: We searched 9 databases from inception (final update December 2017) for RCTs testing a Mediterranean compared with alternate diet for cognitive or brain morphology and function outcomes. Results: Analyses were based on 66 cognitive tests and 1 brain function outcome from 5 included studies (n = 1888 participants). The prescribed Mediterranean diets varied considerably between studies, particularly with regards to quantitative food advice. Only 8/66 (12.1%) of individual cognitive outcomes at trial level significantly favored a Mediterranean diet for cognitive performance, with effect sizes (ESs) ranging from small (0.32) to large (1.66), whereas 2 outcomes favored controls. Data limitations precluded a meta-analysis. Of 8 domain composite cognitive scores from 2 studies, the 3 (Memory, Frontal, and Global function) from PREDIMED (PREvención con DIeta MEDiterránea) were significant, with ESs ranging from 0.39 to 1.29. A posttest comparison at a second PREDIMED site found that the Mediterranean diet modulates the effect of several genotypes associated with dementia risk for some cognitive outcomes, with mixed results. Finally, the risk of low-plasma brain-derived neurotrophic factor was reduced by 78% (OR = 0.22; 95% CI: 0.05, 0.90) in those who consumed a Mediterranean diet compared to control diet at 3 y in this trial. There was no benefit of the Mediterranean diet for incident cognitive impairment or dementia. Conclusions: Five RCTs of the Mediterranean diet and cognition have been published to date. The data are mostly nonsignificant, with small ESs. However, the significant improvements in cognitive domain composites in the most robustly designed study warrant additional research.

Validity of the Mediterranean Diet and Culinary Index (MediCul) for Online Assessment of Adherence to the 'Traditional' Diet and Aspects of Cuisine in Older Adults.

The Mediterranean diet is associated with multiple health benefits. Yet, no tool has been specifically developed to assess adherence to the 'traditional' Mediterranean diet and cuisine within a Western cohort, and validated for online use. We tested the reliability and validity of online administration of the Mediterranean Diet and Culinary Index (MediCul) among middle-aged and older adults. Participants were recruited in January⁻March 2017 from the 45 and Up Study, completing MediCul twice. Test-retest reliability was assessed using the paired t-test, intra-class correlation coefficient (ICC) and Bland-Altman plot. Validity was tested against a three-day food record (FR)-derived MediCul score using Bland-Altman and nutrient trends across the MediCul score tertiles. Participants (n = 84; 60% female; 65.4 years (SD = 5.9)), were overweight (BMI 26.1; SD = 4.0) with 1.7 (SD = 1.5) chronic illnesses/conditions. Sequential MediCul tool scores were 56.1/100.0 and 56.8/100.0, respectively (t = -1.019; p = 0.311). Reliability via ICC (ICC = 0.86, 95% CI: 0.789, 0.910, p < 0.0001) and Bland-Altman was good. In Bland-Altman validity analyses, the tool over-reported FR MediCul score by 5.6 points with no systematic bias ((y = 8.7 - 0.06*x) (95% CI: -0.278, 0.158, p = 0.584)). Nutrient trends were identified for MediCul consistent with expected Mediterranean patterns. Online MediCul administration demonstrated good reliability and moderate validity for assessing adherence to a 'traditional' Mediterranean pattern among older Australians.

Evolution of Mediterranean diets and cuisine: concepts and definitions.

BACKGROUND AND OBJECTIVES: The Mediterranean diet has been demonstrated to provide a range of health benefits in observational and clinical trials and adopted by various dietary guidelines. However, a broad range of definitions exist impeding synthesis across trials. This review aims to provide a historical description of Mediterranean diets, from the ancient to the modern, to inform future educational and diet index tool development representing the 'traditional' Mediterranean diet. METHODS AND STUDY DESIGN: Nine databases were searched from inception to July 2015 to identify papers defining the Mediterranean diet. The definition accepted by the United Nations Educational, Scientific and Cultural Organization (UNESCO) was also reviewed. RESULTS: The 'traditional' Mediterranean diet is described as high in unprocessed plant foods (grains, vegetables, fruits, legumes, nuts/seeds and extra virgin olive oil), moderate in fish/shellfish and wine and low in meat, dairy, eggs, animal fats and discretionary foods. Additional elements relating to cuisine and eating habits identified in this review include frequent intake of home cooked meals; use of moist, lower temperature, cooking methods; eating main meals in company; reduced snacking occasions; fasting practice; ownership of a vegetable garden; use of traditional foods and combinations; and napping after the midday meal. CONCLUSIONS: Scope exists for future tools to incorporate additional elements of the 'traditional' Mediterranean diet to improve the quality, consistency, and synthesis of ongoing research on the Mediterranean diet.