Abstract
AbstractBackgroundThere is increasing evidence that modifiable lifestyle factors account for around 40% of worldwide dementia cases. Given the multifactorial etiology of dementia, multidomain lifestyle interventions have generated major interest. Results from randomized controlled trials (RCTs) suggest that implementing multidomain interventions in at‐risk individuals is an effective strategy to delay disease onset. As per the Obesity‐Related Behavioral Intervention Trials (ORBIT) model, to ensure successful interventions, pre‐efficacy trials are needed to ascertain that each intervention component can yield a predefined clinically significant change (CSC). Therefore, the main objective of this Proof‐of‐Concept was to determine if each individual part of an online multidomain dementia risk reduction program can achieve a CSC in the targeted behavioural risk outcome.MethodThis was a 12‐week, within‐subject, treatment‐only study with three single‐domain groups (Diet, Physical Activity [PA] or Cognitive Engagement [CE]) and one multidomain group. The study enrolled cognitively healthy individuals aged 50‐70 with at least one risk factor among the targeted domains. The personalized intervention was delivered via a digital, coach‐supported application. Primary outcomes were the percentage of participants showing a CSC at study end in each domain. CSCs were defined as a change ≥ 1 point on the Canadian Mediterranean Diet Score, ≥ 300 METs‐min/week on the short version of the International Physical Activity Questionnaire, and ≥ 6 points on the Cognitive Activity Questionnaire, respectively. Additional outcomes comprised feasibility indicators.ResultThirty‐nine participants (mean age=63.1 [51‐68]; 82.1% female) were recruited, with 31 participants enrolled in the single‐domain groups (Diet, N=11; PA, N=7; CE, N=13). Within the single‐domain groups, participants received 7.9 (6‐9) coaching sessions. The number of participants achieving a CSC was 5 (45.5%) in the Diet group, 3 (42.9%) in the PA group and 6 (50.0%) in the CE group. Overall compliance and retention were 93.5% (89.6‐98.0) and 97.4% (92.3‐100), respectively.ConclusionThe results of this study support moving forward to the next ORBIT framework step, which includes refinement of the Luci intervention components and the design of a pilot feasibility trial to test the program in a larger sample of participants.
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