Clinical trial NCT02772523: Control and Intervention Programme on Alzheimer's Disease Risk Factors
Official title: Control and Intervention Programme on Alzheimer's Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Primary Prevention
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 409
Sex: ALL
Minimum age (years): 45
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Recent epidemiologic studies are identifying a number of modifiable risk and protective factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the combination of an early detection of individuals at risk together with interventional studies targeted to the control of modifiable risk factors makes primary prevention programmes to become a new and real therapeutic strategy.

In this scenario, the investigators have designed the ALFAlife study, a programme of control and intervention on the modifiable AD risk factors. Throughout this study, participants will be given a number of healthy lifestyle guidelines that are personalised depending on their specific risk profile. These guidelines refer to smoking and dietary habits and physical, cognitive and social activity. The investigators hypothesis is that the follow-up of these guidelines will favor a change of participants' lifestyle habits towards healthier ones. In addition, the investigators hypothesise that changes in these lifestyle habits will have an effect on objective physiological measures (such as blood pressure and cholesterol levels).


Eligibility criteria: Inclusion Criteria:

* Participants in the ALFA study (NCT01835717)
* Computer literacy
* Accept study's tests and procedures
* Signature of informed consent

Exclusion Criteria:

* Cognitive impairment assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
* Anxiety or depression assessed by clinical criteria that, according to the investigator's evaluation could interfere with the study's follow-up.
* Visual and/or hearing impairment severe enough to impede tests realization.
* Major psychiatric or neurological disorder or other diseases that according to the investigator's evaluation could interfere with the study's follow-up.
* Antecedents of infarction, ischemic heart disease, stroke, peripheral vascular disease, stent or aneurysm clip

Primary outcomes:
measure: Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire
timeFrame: 1 year; change between baseline and one year after
measure: Change in 14-item mediterranean diet Questionnaire
timeFrame: 1 year; change between baseline and one year after
measure: Change in Lifestyle Activities Questionnaire (LAQ)
timeFrame: 1 year; change between baseline and one year after
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelonabeta Brain Research Center
state: Catalonia
Study officials:
References: