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

Abstract

IntroductionIt 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 analysisA 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 disseminationThis 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 numberACTRN12616000868482

Body, Brain, Life for Cognitive Decline (BBL-CD): protocol for a multidomain dementia risk reduction randomized controlled trial for subjective cognitive decline and mild cognitive impairment

“…A major strength of this project is that all the components of the intervention have previously been used in separate successful interventions, 21 , 31 , 32 , 37 but not with a group experiencing cognitive decline. The efficacy and feasibility of dementia risk reduction interventions in this group have been identified as a major knowledge gap by systematic reviews, 26 – 28 and the use of multidomain interventions to combat multiple risk factors simultaneously is considered to be the “gold standard” for risk reduction and prevention interventions.…”

“… 31 – 33 The original intervention included educational modules only and more recently face-to-face physical activity and dietary components have been added. 32 The present study, Body, Brain, Life for Cognitive Decline (BBL-CD), draws from the earlier interventions but introduces some new components and adaptations so that it is suitable for participants with cognitive impairment. This study evaluates the feasibility and efficacy of adapting this program for a cognitively impaired population.…”

An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial

“…The trial protocol for the BBL-GP study is published elsewhere [ 25 ]. Briefly, it is a three-arm, pragmatic, single-blind RCT to reduce the risk of cognitive decline in at-risk individuals attending a general practice.…”

“…The dietitians and exercise physiologist were all staff members within the NHC, but their services for this project were funded by a research grant. Participants at baseline who had unintentional weight loss or weight gain (±5 kg) or scored low on the Australian Recommended Food Score were seen by one of the dietitians (1-hour face-to-face) [ 25 ] and reviewed via phone at weeks 4, 12, and 20. Each participant received a single exercise physiology session that involved an evaluation of their current exercise level, fitness, and any preexisting health conditions and the design of a personal exercise program.…”

Lifestyle Risk Factors and Cognitive Outcomes from the Multidomain Dementia Risk Reduction Randomized Controlled Trial, Body Brain Life for Cognitive Decline (BBL‐CD)

“…This proof‐of‐concept study adapts elements of previously successful trials from other participant groups to the SCD and MCI groups 12‐16 . It is hypothesized that given individualized support, people experiencing cognitive decline can make meaningful lifestyle changes, and in this prodromal stage of dementia the brain will still retain sufficient neuroplasticity to modify the trajectory of the disease.…”