The BetterBrains Trial: Baseline characteristics and trial progress of an online multi‐domain lifestyle intervention trial to delay cognitive decline in middle‐aged adults at risk of dementia

Abstract

AbstractBackgroundBetterBrains is a prospective, blinded endpoint, 24‐month randomised controlled trial (RCT). It aims to test the effectiveness of an online, person‐centred, modifiable risk factor (RF) management program in delaying cognitive decline in middle‐aged adults (aged 40‐70) with a family history of dementia. This study aims to describe blinded baseline characteristics of the randomised sample and provide trial engagement statistics.MethodParticipants enrolled in BetterBrains (betterbrains.org.au) complete all assessments on an online platform. RF assessment related to vascular health, sleep, mood, and social/cognitive engagement was conducted and participants with ≥1 RF were eligible. Participants complete assessments of cognition, general health, medical history, and lifestyle habits at baseline, 12, and 24‐months post‐randomisation. Primary outcome is absence of decline on at‐least one out of four cognitive tests at 24‐months. Participants randomised to the intervention arm receive a minimum of 6 person‐centred telehealth consultations over 12‐months with an allied health clinician trained in motivational interviewing. All participants receive monthly educational blogposts.ResultSince August 2021, 1518 participants have enrolled and 856 (56%) were randomised (Figure 1). Blinded baseline analyses reveal that randomised participants are mostly female (84%), white (93%), live in metropolitan areas (73%), and all report a first‐degree dementia family history. Mean age is 60 years (±6.7) and participants have 15.4 years of education (±3.9) on average. Mean number of reported RFs is 5 out of a possible 19. Readiness to change lifestyle behaviours to reduce dementia risk was high, with 71% of participants indicating implementation of at‐least some lifestyle changes prior to trial entry. Only 3% of randomised participants have withdrawn. Of participants who have reached 12‐months post‐randomisation (N = 349), 74% have completed follow‐up cognitive testing.ConclusionLow attrition and high follow‐up rates suggest high acceptability and feasibility of the online BetterBrains methodology. The sample is likely at increased risk of dementia, due to high prevalence of first‐degree dementia family history, female gender, and co‐occurrence of multi‐domain modifiable dementia RFs. Presentation of findings will include a detailed breakdown of study methodology, baseline demographic/risk characteristics, and trial progress.