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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study evaluates the feasibility of implementing a Brain Health Service (BHS) to assess and reduce dementia risk in individuals with Subjective Cognitive Decline (SCD). A total of 120 participants will be recruited from the Cognitive Disorders Unit at Hospital del Mar and randomly assigned to either a personalized intervention group or a control group receiving general prevention advice. The study will assess individual biological and lifestyle-related risk factors for dementia and use validated tools to estimate each participant's risk profile. Participants in the intervention group will be offered a structured dementia risk communication and counseling process, with the option to receive or decline their individual risk estimate. The intervention consists of a 6-month multimodal program combining digital and in-person strategies tailored to each participant's risk level. These strategies include personalized recommendations to improve lifestyle factors such as diet, physical activity, sleep, social engagement, and cognitive stimulation. The main objectives are to evaluate the feasibility of delivering this type of service, including recruitment, adherence, and retention; to assess the psychological impact of communicating dementia risk; and to examine changes in lifestyle behaviors and cognitive outcomes over time compared with a control group. This study addresses the need for early, personalized prevention strategies for individuals with SCD and may inform broader implementation of preventive BHS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 85
Healthy Volunteers: f
View:

• Participants aged 55 to 85 with subjective cognitive complaints and normal screening test performance at the hospital.

• Participants must have a minimal educational level for a neuropsychological assessment and a minimal digital literacy for the usage of smartphones, computers and Internet.

Locations
Other Locations
Spain
Fundació Pasqual Maragall
RECRUITING
Barcelona
Contact Information
Primary
Oriol Grau Rivera
ograu@barcelonabeta.org
+34 933 26 31 90
Time Frame
Start Date: 2026-09-15
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 120
Treatments
Active_comparator: Control
Participants in the control arm will receive general recommendations on dementia risk reduction at the beginning of the study, reflecting standard preventive advice.~They will have access to a mobile application providing information on dementia risk factors; however, the application will not include personalized feedback or interactive intervention components.~Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.
Experimental: Personalized intervention
Participants in the experimental arm will receive a 6-month personalized, multimodal intervention tailored to their individual dementia risk profile.~The intervention includes components targeting key domains of brain health, including nutrition, physical activity, cognitive training, and psychoeducation, with the intensity and combination of components adapted according to risk level.~Participants will have access to a mobile application providing personalized feedback on lifestyle behaviors and interactive support to promote adherence to the intervention.~Participants will also be provided with a wearable fitness tracker to support monitoring of physical activity and sleep.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital del Mar Research Institute (IMIM), Hospital del Mar
Leads: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

This content was sourced from clinicaltrials.gov