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.
Background
With no cure for dementia and the number of people living with the condition predicted to rapidly rise, there is an urgent need for dementia risk reduction and prevention interventions. Modifiable lifestyle risk factors have been identified as playing a major role in the development of dementia; hence, interventions addressing these risk factors represent a significant opportunity to reduce the number of people developing dementia. Relatively few interventions have been trialed in older participants with cognitive decline (secondary prevention).


Objectives
This study evaluates the efficacy and feasibility of a multidomain lifestyle risk reduction intervention for people with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).


Methods
This study is an 8-week, two-arm, single-blind, randomized controlled trial (RCT) of a lifestyle modification program to reduce dementia risk. The active control group receives the following four online educational modules: dementia literacy and lifestyle risk, Mediterranean diet (MeDi), cognitive engagement and physical activity. The intervention group also completes the same educational modules but receives additional practical components including sessions with a dietitian, online brain training and sessions with an exercise physiologist to assist with lifestyle modification.


Results
Primary outcome measures are cognition (The Alzheimer's Disease Assessment Scale-Cognitive-Plus [ADAS-Cog-Plus]) and a composite lifestyle risk factor score for Alzheimer's disease (Australian National University - Alzheimer's Disease Risk Index [ANU-ADRI]). Secondary outcome measures are motivation to change lifestyle (Motivation to Change Lifestyle and Health Behaviour for Dementia Risk Reduction [MCLHB-DRR]) and health-related quality of life (36-item Short Form Health Survey [SF-36]). Feasibility will be determined through adherence to diet (Mediterranean Diet Adherence Screener [MEDAS] and Australian Recommended Food Score [ARFS]), cognitive engagement (BrainHQ-derived statistics) and physical activity interventions (physical activity calendars). Outcomes are measured at baseline, immediately post-intervention and at 3- and 6-month follow-up by researchers blind to group allocation.


Discussion
If successful and feasible, secondary prevention lifestyle interventions could provide a targeted, cost-effective way to reduce the number of people with cognitive decline going on to develop Alzheimer's disease (AD) and other dementias.
['McMaster|Mitchell|M|', 'Kim|Sarang|S|', 'Clare|Linda|L|', 'Torres|Susan J|SJ|', "D'Este|Catherine|C|", 'Anstey|Kaarin J|KJ|']
D000368:Aged D003071:Cognition D060825:Cognitive Dysfunction D003704:Dementia D004032:Diet D015444:Exercise D015438:Health Behavior D006801:Humans D008019:Life Style D009042:Motivation D010353:Patient Education as Topic D011788:Quality of Life D016032:Randomized Controlled Trials as Topic D012107:Research Design D012307:Risk Factors D040242:Risk Reduction Behavior D016037:Single-Blind Method
dementia risk reduction subjective cognitive decline mild cognitive impairment secondary prevention Alzheimer’s disease dementia prevention multidomain lifestyle intervention