B-HEALTH (Spain)

The B-HEALTH Project
− Implementation of a Brain Health Service for Personalized Stratification and Prevention of Dementia Risk

B-HEALTH evaluates the feasibility of implementing a Brain Health Services in a real-world clinical setting to prevent cognitive decline in participants with subjective cognitive decline. It estimates each participant’s individual dementia risk and provides structured risk communication and counselling and a personalized six-month multimodal intervention. Intervention intensity is adapted according to baseline dementia risk. The program combines individual and group sessions with a digital component through the BrainNet mobile application.

Latest page update: 24 July, 2026

Summary

The B-HEALTH study is a two-arm randomized controlled trial (RCT) designed to evaluate the feasibility of implementing a Brain Health Services (BHS) in a real-world clinical setting to prevent cognitive decline in 120 participants with subjective cognitive decline (SCD) aged 55-85 referred from the Neurology Unit of Hospital del Mar.

The BHS comprises three integrated components: (1) dementia risk assessment, combining demographic characteristics, modifiable lifestyle and vascular risk factors, and blood-based Alzheimer’s disease biomarkers (plasma p-tau217) to estimate each participant’s individual dementia risk; (2) structured risk communication and counselling, providing participants with clear, evidence-based information about their individualized risk profile and opportunities for risk reduction; and (3) a personalized six-month multimodal intervention.

Based on the estimated dementia risk, participants are classified into low-, intermediate-, or high-risk categories and undergo stratified randomization (1:1) to either the intervention (n = 60) or control group (n = 60). Participants allocated to the intervention arm are offered personalized risk communication and counselling, followed by a six-month multidomain intervention tailored to their individual risk profile. The intervention targets diet, physical activity, sleep health, cognitive training, social engagement, and the management of vascular and other modifiable risk factors. Intervention intensity is adapted according to baseline dementia risk, with participants at higher risk receiving a greater number and intensity of intervention components, as well as more frequent in-person support. The programme combines individual and group sessions delivered face-to-face with a digital component through the BrainNet mobile application, which supports monitoring, self-management, and adherence. Participants allocated to the control group receive general recommendations for dementia risk reduction.

Aims of the project

• To evaluate the feasibility of implementing a personalized risk stratification and risk reduction program by assessing overall recruitment and dropout rates and adherence to a multimodal intervention.
• To evaluate the psychological impact of dementia risk communication among participants who choose to receive an individualized risk estimate, compared with participants who do not receive it (either from the control group or from the intervention group but who decline to be informed of their risk).
• To evaluate differences in cognitive and lifestyle changes between participants undergoing a multimodal intervention vs controls receiving general prevention advice.
• To investigate associations between baseline modifiable dementia risk (LIBRA index), plasma AD biomarker levels, and baseline and longitudinal cognitive performance assessed using conventional and digital cognitive tests.
• To characterize modifiable and biological (AD plasma biomarkers) risk factors in a prospective cohort of care-seeking SCD participants.

Location

Barcelona, Spain

Local setting

Potentially eligible patients with subjective cognitive decline (SCD) seeking medical advice will be recruited through the Neurology Unit at Hospital del Mar using both prospective and retrospective approaches. Recruitment will include newly referred patients as well as individuals already enrolled in the DegMar cohort, a clinical research database comprising patients assessed at the Hospital del Mar Neurology Unit who have provided informed consent for the use of a minimum set of their clinical data for research purposes.

Potential participants will be contacted by telephone and invited to access the study website, where they will receive detailed information about the study and complete an online enrollment process comprising an electronic informed consent form and a prescreening questionnaire. The prescreening questionnaire will assess eligibility and collect information on dementia risk factors. Eligible participants will be invited to attend an in-person baseline visit at the Barcelonaβeta Brain Research Center (BBRC).

Organizations involved

B-HEALTH is a collaboration between the Barcelonaβeta Brain Research Center (BBRC), the Barcelona Brain Health Center (BBHC), the Hospital del Mar and its research institute (Hospital del Mar Research Institute).

Principal Investigator (PI)

Oriol Grau-Rivera, MD, PhD,
Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation

Research team

Barcelonaβeta Brain Research Center, Pasqual Maragall Foundation
Natalia Soldevila-Domenech (Co-PI)
Ana Fernández Arcos (Co-PI)
Andrea Horta-Barba (Co-PI)
Helena Palma Gudiel
Andreea Rădoi
Iva Knezevic
Eloisa Antonaglia
Beatrice Roncarati
Mireia Sánchez Gutiérrez

Hospital del Mar
Marta Gutierrez Gandara

Barcelona Brain Health Center
Sònia Abilleira Castells

Duration of the intervention

Project duration

Project start date

Project end date

Current stage of the project

Ongoing; participant recruitment phase

Number of study participants

Target population

Individuals aged 55–85 years with SCD referred from the Neurology Unit of Hospital del Mar, who have normal cognitive screening test performance. Participants must have sufficient educational attainment to complete a comprehensive neuropsychological assessment and access to a smartphone or computer with an Internet connection.

Outcomes

Primary outcome

The primary endpoint is the feasibility of the multimodal intervention, which will be assessed by (1) recruitment rate, defined as the proportion of eligible participants who are randomized into the study; (2) adherence, measured by completion of ecological momentary assessments (EMAs), online questionnaires, attendance at in-person intervention activities, and participation in online cognitive training sessions; (3) retention rate, defined as the proportion of participants completing the 6-month intervention period.

Secondary outcomes

Secondary outcomes include: (1) the feasibility and acceptability of implementing a personalized dementia risk disclosure and counselling programme for individuals with SCD. Feasibility will be assessed through uptake, adherence, and completion rates across the multivisit protocol, while acceptability will be evaluated using psychological measures including distress, anxiety, depressive symptoms, perceived stress, coping, well-being, and attitudes towards dementia risk disclosure; and (2) the effectiveness of the personalized multimodal intervention on health outcomes, including the adoption of healthier lifestyle behaviours and changes in cognitive performance. Changes in the Lifestyle for Brain Health (LIBRA) index will be used to assess the intervention’s effect on modifiable dementia risk factors.

Exploratory outcomes

Exploratory outcomes will include (1) delineating the prevalence of modifiable and biological dementia risk factors, (2) examining associations of modifiable risk factors, and plasma AD biomarker status with performance in digital cognitive assessments, (3) evaluating additional implementation outcomes, including identification of implementation barriers and qualitative insights on study acceptability, and (4) incidence of cognitive impairment and healthcare resource utilization over up to 5 years, based on electronic health records (EHRs).

Intervention

The multidomain intervention

Domains

• Diet
• Physical activity
• Sleep
• Cognition
• Social activity

Two arms

• Arm 1: intervention group (n = 60), offered a multimodal intervention and a structured Dementia Risk Communication and Counseling program including: a risk education session, a counselling follow-up session, an optional individual session to disclose personal dementia risk related to AD biomarkers and the delivery of the participant’ personalised prevention plan.
  • Low risk group (n=20): Fitbit activity tracker and access to the BrainNet app with personalized counselling for dementia prevention and weekly feedback.
  • Intermediate risk group (n=20): the aforementioned for the low risk group plus individual cognitive training sessions through a digital platform (30min; 2-3 times/week) and monthly psychoeducational group sessions.
  • High risk group (n=20): the aforementioned for the intermediate risk group plus monthly individual nutrition counselling visits and guided physical activity sessions in a gymnasium (60 min; 1 session/week).

• Arm 2: control group (n = 60), Participants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study through the BrainNet mobile application, but without personalized feedback or interactive intervention components

Technology

A digital BrainNet mobile application will be used with the purpose of

• Monitor lifestyle changes
• Data collection through mobile-assisted ecological momentary assessments (EMAs) on participants’ physical activity, adherence to the Mediterranean Diet and sleep quality (daily), participation on cognitive and social activities (weekly)
• Personalized feedback will be provided weekly with recommendations to improve in the most affected areas
• A calendar with social activities in the city of Barcelona will be included in the app to foster social engagement among intervention participants
• Co-design of the app: a 60 minute workshop was held with a group of approximately 6 participants aged 55-85 with SCD from the Neurology Department of Hospital del Mar. The aim was to gather feedback on a demo version of the project’s mobile application and improve the accessibility of the app and its alignment with participants’ requirements and abilities.
• Participants wore activity trackers to self-monitor physical activity levels
• Cognitive training carried out through a web-based platform (NeuronUP)

Results

No results have been published.

Acknowledgements

This study has been funded by the Instituto de Salud Carlos III (ISCIII) through project PI24/00116 and co-funded by the European Union.

We sincerely appreciate the participation and commitment of all participants to the B-HEALTH study.

We thank all investigators, on-site study staff, and members of the B-HEALTH study group for their invaluable efforts in conducting the fieldwork.

The B-HEALTH research team