A 12-week multidomain intervention versus active control to reduce risk of Alzheimer’s disease: study protocol for a randomized controlled trial

Background: Disappointing results from clinical trials of disease-modifying interventions for Alzheimer’s dementia (AD), along with reliable identification of modifiable risk factors in mid life from epidemiological studies, have contributed to calls to invest in risk-reduction interventions. It is also well known that AD-related pathological processes begin more than a decade before the development of clinical signs. These observations suggest that lifestyle interventions might be most effective when targeting non-symptomatic adults at risk of AD. To date, however, the few dementia risk-reduction programs available have targeted individual risk factors and/or were restricted to clinical settings. The current study describes the development of an evidence-based, theoreticallydriven multidomain intervention to reduce AD risk in adults at risk. Method: The design of Body Brain Life (BBL) is a randomized controlled trial (RCT) to evaluate a 12-week online AD risk-reduction intervention. Eligible participants with several modifiable risk factors on the Australian National University (ANU) AD Risk Index (ANU-ADRI) are randomly allocated to an online only group, an online and face-toface group, or an active control group. We aim to recruit 180 participants, to undergo a comprehensive cognitive and physical assessment at baseline, post-intervention, and 6-month follow-up assessment. The intervention comprises seven online modules (dementia literacy, risk factor education, engagement in physical, social, and cognitive lifestyles, nutrition, and health monitoring) designed using contemporary models of health behavior change. Discussion: The BBL program is a novel online intervention to reduce the risk of AD in middle-aged adults at risk. The trial is currently under way. It is hypothesized that participants in the intervention arms will make lifestyle changes in several domains, and that this will lead to a reduction in their AD risk profile. We also expect to show that health behavior change is underpinned by changes in psychological determinants of behavior. If successful, the findings will contribute to the development of further dementia risk reduction interventions, and thus contribute to the urgent need to lower dementia risk factors in the population to alter future projections of disease prevalence. Longer follow-up of BBL participants and replications using large samples are required to examine whether reduction in AD risk factors will be associated with reduced prevalence.BBL is funded by the National Health and Medical Research Council as part of the Dementia Collaborative Research Centres. Anstey and Cherbuin are funded by NHMRC Fellowships 1002560 and 471501

Computerized Cognitive Training with Older Adults: A Systematic Review

A systematic review to examine the efficacy of computer-based cognitive interventions for cognitively healthy older adults was conducted. Studies were included if they met the following criteria: average sample age of at least 55 years at time of training; participants did not have Alzheimer’s disease or mild cognitive impairment; and the study measured cognitive outcomes as a result of training. Theoretical articles, review articles, and book chapters that did not include original data were excluded. We identified 151 studies published between 1984 and 2011, of which 38 met inclusion criteria and were further classified into three groups by the type of computerized program used: classic cognitive training tasks, neuropsychological software, and video games. Reported pre-post training effect sizes for intervention groups ranged from 0.06 to 6.32 for classic cognitive training interventions, 0.19 to 7.14 for neuropsychological software interventions, and 0.09 to 1.70 for video game interventions. Most studies reported older adults did not need to be technologically savvy in order to successfully complete or benefit from training. Overall, findings are comparable or better than those from reviews of more traditional, paper-and-pencil cognitive training approaches suggesting that computerized training is an effective, less labor intensive alternative

A Social Model for Health Promotion for an Aging Population: Initial Evidence on the Experience Corps Model

This report evaluates whether a program for older volunteers, designed for both generativity and health promotion, leads to short-term improvements in multiple behavioral risk factors and positive effects on intermediary risk factors for disability and other morbidities. The Experience Corps® places older volunteers in public elementary schools in roles designed to meet schools\u27 needs and increase the social, physical, and cognitive activity of the volunteers. This article reports on a pilot randomized trial in Baltimore, Maryland. The 128 volunteers were 60-86 years old; 95% were African American. At follow-up of 4-8 months, physical activity, strength, people one could turn to for help, and cognitive activity increased significantly, and walking speed decreased significantly less, in participants compared to controls. In this pilot trial, physical, cognitive, and social activity increased, suggesting the potential for the Experience Corps to improve health for an aging population and simultaneously improve educational outcomes for children

Importance of Driving and Potential Impact of Driving Cessation for Rural and Urban Older Adults

PurposeAnalyses compared older drivers from urban, suburban, and rural areas on perceived importance of continuing to drive and potential impact that driving cessation would have on what they want and need to do.MethodsThe AAA LongROAD Study is a prospective study of driving behaviors, patterns, and outcomes of older adults. A cohort of 2,990 women and men 65‐79 years of age was recruited during 2015‐2017 from health systems or primary care practices near 5 study sites in different parts of the United States. Participants were classified as living in urban, surburban, or rural areas and were asked to rate the importance of driving and potential impact of driving cessation. Logistic regression models adjusted for sociodemographic and driving‐related characteristics.FindingsThe percentages of older drivers rating driving as “completely important” were 76.9%, 79.0%, and 83.8% for urban, suburban, and rural drivers, respectively (P = .009). The rural drivers were also most likely to indicate driving cessation would have a high impact on what they want or need to do (P < .001). After adjustment for sociodemographic and driving‐related characteristics, there was a 2‐fold difference for rural versus urban older drivers in odds that driving cessation would have a high impact on what they need to do (OR = 2.03; 95% CI: 1.60‐2.58).ConclusionsOlder drivers from rural areas were more likely to rate driving as highly important and the prospect of driving cessation as very impactful. Strategies to enhance both the ability to drive safely and the accessibility of alternative sources of transportation may be especially important for older rural adults.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/153160/1/jrh12369_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/153160/2/jrh12369.pd

Protocol for a pragmatic randomised controlled trial of Body Brain Life-General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting

Introduction It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0 million Alzheimer's disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia. Methods and analysis A randomised controlled trial (RCT) is being conducted to evaluate three intervention programmes using a pragmatic approach suitable to the clinic: (1) a 12-week online and face-To-face dementia risk-reduction intervention (Body Brain Life-General Practice (BBL-GP)); (2) a 6-week face-To-face group lifestyle modification programme (LMP); and (3) a 12-week email-only programme providing general health information. We aim to recruit 240 participants, aged 18 and over, to undergo a comprehensive cognitive and physical assessment at baseline and follow-ups (postintervention, 18, 36 and 62 weeks). The primary outcome is dementia risk measured with the modified version of the Australian National University-Alzheimer's Disease Risk Index Short Form. Secondary outcomes are cognitive function measured with Trails A and B, and the Digit Symbol Modalities Test; physical activity with moderate-vigorous physical activity and the International Physical Activity Questionnaire; depression with the Centre for Epidemiological Studies Depression; cost evaluation with the 12-item Short Form Health Survey, Framingham Coronary Heart Disease Risk Score and Australian Type 2 Diabetes Risk Assessment Tool; diet quality with the Australian Recommended Food Score; and sleep quality with the Pittsburgh Sleep Quality Index. Ethics and dissemination This RCT is a novel pragmatic intervention applied in a primary care setting to reduce the dementia risk exposure in adults at high risk. If successful, BBL-GP and LMP will provide a versatile, evidence-based package that can be easily and quickly rolled out to other primary care settings and which can be scaled up at relatively low cost compared with other strategies involving intensive interventions. Trial registration number ACTRN12616000868482This work was supported by National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Cognitive Health and the development of original BBL modules was funded by the NHMRC Dementia Collaborative Research Centres. KJA is funded by NHMRC Fellowship APP1102694

Protocol for a pragmatic randomised controlled trial of Body Brain Life-General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting

INTRODUCTION: It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0&thinsp;million Alzheimer\u27s disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia. METHODS AND ANALYSIS: A randomised controlled trial (RCT) is being conducted to evaluate three intervention programmes using a pragmatic approach suitable to the clinic: (1) a 12-week online and face-to-face dementia risk-reduction intervention (Body Brain Life-General Practice (BBL-GP)); (2) a 6-week face-to-face group lifestyle modification programme (LMP); and (3) a 12-week email-only programme providing general health information. We aim to recruit 240 participants, aged 18 and over, to undergo a comprehensive cognitive and physical assessment at baseline and follow-ups (postintervention, 18, 36 and 62 weeks). The primary outcome is dementia risk measured with the modified version of the Australian National University-Alzheimer\u27s Disease Risk Index Short Form. Secondary outcomes are cognitive function measured with Trails A and B, and the Digit Symbol Modalities Test; physical activity with moderate-vigorous physical activity and the International Physical Activity Questionnaire; depression with the Centre for Epidemiological Studies Depression; cost evaluation with the 12-item Short Form Health Survey, Framingham Coronary Heart Disease Risk Score and Australian Type 2 Diabetes Risk Assessment Tool; diet quality with the Australian Recommended Food Score; and sleep quality with the Pittsburgh Sleep Quality Index. ETHICS AND DISSEMINATION: This RCT is a novel pragmatic intervention applied in a primary care setting to reduce the dementia risk exposure in adults at high risk. If successful, BBL-GP and LMP will provide a versatile, evidence-based package that can be easily and quickly rolled out to other primary care settings and which can be scaled up at relatively low cost compared with other strategies involving intensive interventions.&nbsp

Parallel but not equivalent: Challenges and solutions for repeated assessment of cognition over time

OBJECTIVE: Analyses of individual differences in change may be unintentionally biased when versions of a neuropsychological test used at different follow-ups are not of equivalent difficulty. This study's objective was to compare mean, linear, and equipercentile equating methods and demonstrate their utility in longitudinal research. STUDY DESIGN AND SETTING: The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE, N = 1,401) study is a longitudinal randomized trial of cognitive training. The Alzheimer's Disease Neuroimaging Initiative (ADNI, n = 819) is an observational cohort study. Nonequivalent alternate versions of the Auditory Verbal Learning Test (AVLT) were administered in both studies. RESULTS: Using visual displays, raw and mean-equated AVLT scores in both studies showed obvious nonlinear trajectories in reference groups that should show minimal change and poor equivalence over time (ps ≤ .001), and raw scores demonstrated poor fits in models of within-person change (root mean square errors of approximation, RMSEAs > 0.12). Linear and equipercentile equating produced more similar means in reference groups (ps ≥ .09) and performed better in growth models (RMSEAs < 0.05). CONCLUSION: Equipercentile equating is the preferred equating method because it accommodates tests more difficult than a reference test at different percentiles of performance and performs well in models of within-person trajectory. The method has broad applications in both clinical and research settings to enhance the ability to use nonequivalent test forms

The Role of Education and Intellectual Activity on Cognition

Although educational attainment has been consistently related to cognition in adulthood, the mechanisms are still unclear. Early education, and other social learning experiences, may provide the skills, knowledge, and interest to pursue intellectual challenges across the life course. Therefore, cognition in adulthood might reflect continued engagement with cognitively complex environments. Using baseline data from the Baltimore Experience Corps Trial, multiple mediation models were applied to examine the combined and unique contributions of intellectual, social, physical, creative, and passive lifestyle activities on the relationship between education and cognition. Separate models were tested for each cognitive outcome (i.e., reading ability, processing speed, memory). With the exception of memory tasks, findings suggest that education-cognition relations are partially explained by frequent participation in intellectual activities. The association between education and cognition was not completely eliminated, however, suggesting that other factors may drive these associations

Impact of Experience Corps® Participation on Children’s Academic Achievement and School Behavior

This article reports on the impact of the Experience Corps® (EC) Baltimore program, an intergenerational, school-based program aimed at improving academic achievement and reducing disruptive school behavior in urban, elementary school students in Kindergarten through third grade (K-3). Teams of adult volunteers aged 60 and older were placed in public schools, serving 15 h or more per week, to perform meaningful and important roles to improve the educational outcomes of children and the health and well-being of volunteers. Findings indicate no significant impact of the EC program on standardized reading or mathematical achievement test scores among children in grades 1–3 exposed to the program. K-1st grade students in EC schools had fewer principal office referrals compared to K-1st grade students in matched control schools during their second year in the EC program; second graders in EC schools had fewer suspensions and expulsions than second graders in non-EC schools during their first year in the EC program. In general, both boys and girls appeared to benefit from the EC program in school behavior. The results suggest that a volunteer engagement program for older adults can be modestly effective for improving selective aspects of classroom behavior among elementary school students in under-resourced, urban schools, but there were no significant improvements in academic achievement. More work is needed to identify individual- and school-level factors that may help account for these results

The selection of comparators for randomized controlled trials of health-related behavioral interventions : recommendations of an NIH expert panel

Funding and logistical support for the expert panel was provided by the National Institutes of Health Office of Behavioral and Social Sciences Research.Peer reviewedPostprin