Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health
ToBrainHealth
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedMarch 27, 2026
March 1, 2026
3 months
January 28, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to Recommended Healthy Lifestyle Activities
Adherence will be defined as the percentage of recommended healthy lifestyle activities (e.g., physical activity, cognitive training, sleep routines, social and psychological exercises) that each participant completes during the 8-week intervention. It will be calculated from ToBrainHealth platform logs, self-reported questionnaires and Fitbit HR data, summarised as an overall adherence score for each participant and compared across intervention arms.
From baseline to the end of the 8-week intervention period.
Study Arms (3)
Generic Lifestyle Education
SHAM COMPARATORParticipants receive general, non-personalised educational materials about healthy lifestyle habits, including information on nutrition, physical activity, sleep, cognitive stimulation and psychological wellbeing. They do not receive personalised recommendations nor access to adaptive features of the ToBrainHealth platform. Participants complete periodic online questionnaires to report their activities, but no tailored guidance or coaching is provided.
Digital Personalised Intervention
ACTIVE COMPARATORParticipants use the ToBrainHealth digital platform, which provides personalised lifestyle recommendations based on individual behavioural and psychological profiles. The platform delivers adaptive intervention strategies, remote asynchronous monitoring and feedback. Participants also wear a Fitbit HR device that synchronises activity and sleep data with the platform. No human coaching is provided; all support is delivered digitally through the platform's personalised features.
Digital Personalised Intervention + Coaching
EXPERIMENTALParticipants receive the full personalised digital intervention described for Arm 2, including tailored recommendations, adaptive strategies, digital monitoring and wearable integration. In addition, they receive intensive professional health coaching throughout the 8-week programme. Coaching sessions aim to enhance motivation, address barriers to behaviour change, reinforce adherence and optimise long-term adoption of healthy lifestyle habits.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy adult participating in the Barcelona Brain Health Initiative
You may not qualify if:
- Neurological or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Politecnica de Madridcollaborator
- Institut Guttmannlead
Study Sites (1)
Guttmann Barcelona. Institut de Salut Cerebral i Neurorehabilitació
Barcelona, Catalonia, 08027, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants remain blinded to their intervention assignment. Group allocation is determined by the principal investigator and kept in sealed envelopes. At the baseline visit, the evaluator opens the envelope immediately before administering the assessments; therefore, evaluators are not blinded during the assessment itself but remain unaware of the assignment until that moment. Other study personnel not involved in delivering the intervention (e.g., data analysts) remain masked throughout the study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Principal Investigator
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 4, 2026
Study Start
February 15, 2026
Primary Completion
May 1, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared publicly at this stage. The dataset contains sensitive health and neuropsychological information, and full anonymization without risk of re-identification cannot be guaranteed. In addition, participant consent does not currently include provisions for broad data sharing. Aggregated results will be made publicly available through publications and reports. Future data sharing with qualified researchers may be considered upon reasonable request, subject to ethical approval, data protection regulations, and appropriate data-use agreements.