Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health

Summary

Ageing is associated with a rising burden of neurological disorders, particularly dementia, which are now the leading cause of disability worldwide. Many dementia cases could potentially be prevented by modifying lifestyle factors such as physical inactivity, unhealthy diet, poor sleep, low social engagement and psychological distress. The Barcelona Brain Health Initiative (BBHI), a longitudinal cohort of more than 6,000 adults aged 40-75 years, has shown substantial inter-individual variability in lifestyle and psychological profiles and has identified subgroups at higher risk for poorer brain health.

ToBrainHealth is an 8-week, three-arm controlled intervention nested within BBHI. It evaluates different levels of personalisation and support to optimise healthy lifestyle behaviours using the ToBrainHealth platform, a digital platform that delivers recommendations, collects self-reported behaviours and integrates data from wearable activity trackers.

A total of 120 BBHI volunteers classified as moderate- or high-risk based on previous lifestyle and psychological questionnaires will be selected (40 per arm). Allocation to study arms will be pseudo-randomised, stratified by age, sex, and lifestyle and psychological profiles.

The three groups are: (1) a control group receiving only generic, non-personalised education about healthy lifestyles and regular online questionnaires, without use of ToBrainHealth platform tailoring; (2) a digital personalised intervention group using ToBrainHealth platform to deliver tailored lifestyle recommendations, adaptive intervention strategies and remote asynchronous supervision, supported by data from questionnaires and wearables; and (3) a digital personalised intervention plus intensive health-coaching group, which receives the same ToBrainHealth platform-based programme plus structured, proactive support and supervision by health professionals to enhance motivation and adherence.

The primary outcome is adherence to the lifestyle intervention, operationalised as the percentage of recommended activities and goals achieved during the 8-week programme, based on platform's logs, questionnaires and wearable data. The study will test whether lifestyle and psychological profile increases adherence compared with generic education, and whether adding intensive coaching provides additional benefit (expected gradient: coaching \> digital only \> control).

Secondary outcomes include the clinical impact of the intervention on brain-health-related measures. All participants will undergo pre- and post-intervention assessments including a brief medical evaluation (vital signs and anthropometrics), a digital neuropsychological battery, and questionnaires on motivation, lifestyle and psychosocial variables. These data will be analysed together with existing BBHI longitudinal information to explore changes in cognitive performance, health status and psychological wellbeing, and to characterise patterns and predictors of adherence across intervention arms.

The trial will also assess feasibility and acceptability of ToBrainHealth platform as a remote monitoring and coaching tool for brain-health promotion. Results are expected to generate new knowledge on the role of psychological and lifestyle profiles in adherence, and to inform scalable, technology-supported, personalised interventions aimed at preserving brain health and reducing the long-term risk of cognitive decline in community-dwelling adults.

Conditions

• Brain Health Activities
• Cognition
• Prevention
• Cognitive Decline

Interventions

BEHAVIORAL

Generic Lifestyle Education

Participants receive non-personalized educational materials about healthy lifestyle habits related to brain health. They complete periodic questionnaires but do not receive individualized recommendations, adaptive digital support, or coaching. This condition serves as a comparison group to evaluate the added benefit of personalized digital interventions.

BEHAVIORAL

ToBrainHealth Personalised Digital Intervention

This intervention uses the ToBrainHealth digital platform to deliver personalised lifestyle recommendations and adaptive behaviour-change strategies based on each participant's psychological and behavioural profile. The platform integrates data from a Fitbit HR wearable to monitor activity and sleep. Guidance and monitoring are entirely digital, with no human coaching provided.

BEHAVIORAL

ToBrainHealth Personalised Digital Intervention with Coaching

This intervention includes the full personalised digital program described above, enhanced with intensive, structured health coaching delivered by trained professionals. Coaching sessions aim to support motivation, address individual barriers, and reinforce adherence to lifestyle recommendations. This arm allows assessment of the added value of professional guidance beyond digital personalisation alone.

Sponsors & Collaborators

• Universidad Politecnica de Madrid

  collaborator OTHER

• Institut Guttmann

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-15

Primary Completion

2026-05-01

Completion

2026-08-31

Countries

• Spain

Study Locations