Psychological and Lifestyle Factors That Predict Adherence of Multi-domain Interventions for Promoting Brain Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adherence to Recommended Healthy Lifestyle Activities
研究概览
简要总结
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.
详细描述
ToBrainHealth Intervention Trial - Three-arm personalised lifestyle optimisation study The ToBrainHealth intervention trial is an 8-week, three-arm controlled study designed to evaluate the impact of personalised, technology-supported strategies on adherence to healthy lifestyle recommendations in community-dwelling adults. The study is embedded in the Barcelona Brain Health Initiative (BBHI), a large longitudinal cohort that investigates determinants of brain health across ageing. The trial addresses a crucial challenge in brain-health promotion: despite strong evidence that modifiable lifestyle factors positively influence resilience and reduce the risk of cognitive decline, long-term adherence to lifestyle interventions remains low.
Background and Rationale Ageing is associated with increasing prevalence of neurological disorders, particularly dementia, which represent the leading cause of disability globally. Cognitive decline is not inevitable; ~20% of older adults maintain youthful cognitive performance, reflecting brain resilience processes. Research from the BBHI cohort (>6,000 adults aged 40-75 years) demonstrates that lifestyle quality, psychological wellbeing, sleep, social engagement and physical activity predict brain health trajectories. However, substantial variability exists between individuals.
To better understand this variability, latent profile analysis of lifestyle and psychosocial data from the BBHI cohort identified three behavioural-psychological profiles: High Risk, Moderate Risk and Low Risk. High- and Moderate-Risk individuals exhibit poorer habits and lower levels of protective traits such as sense of coherence, self-reflection or emotional wellbeing, all of which influence adherence. These profiles provide an empirical basis for targeted interventions.
Lifestyle interventions often fail due to barriers such as lack of personalisation, limited feedback, insufficient motivational support, technical difficulties, and fluctuating emotional states. Evidence shows that technology-supported programmes can enhance adherence when they provide clear guidance, personalised content, adaptive strategies, monitoring features, and-when appropriate-professional supervision. The ToBrainHealth digital solution operationalises this knowledge to deliver multimodal lifestyle recommendations tailored to each participant's psychological and behavioural profile.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participating in the Barcelona Brain Health Initiative
排除标准
- •Neurological or psychiatric disease
研究组 & 干预措施
Generic Lifestyle Education
Participants 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.
干预措施: Generic Lifestyle Education (Behavioral)
Digital Personalised Intervention
Participants 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.
干预措施: ToBrainHealth Personalised Digital Intervention (Behavioral)
Digital Personalised Intervention + Coaching
Participants 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.
干预措施: ToBrainHealth Personalised Digital Intervention with Coaching (Behavioral)
结局指标
主要结局
Adherence to Recommended Healthy Lifestyle Activities
时间窗: From baseline to the end of the 8-week intervention period.
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.
次要结局
未报告次要终点
研究者
Gabriele Cattaneo
Professor, Principal Investigator
Institut Guttmann