Control and Intervention Programme on Alzheimer's Disease Risk Factors (ALFAlife)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle recommendations
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease focused on measuring Primary Prevention
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
Sites / Locations
- Barcelonabeta Brain Research Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire
Change in 14-item mediterranean diet Questionnaire
Change in Lifestyle Activities Questionnaire (LAQ)
Secondary Outcome Measures
Full Information
NCT ID
NCT02772523
First Posted
May 6, 2016
Last Updated
July 20, 2020
Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02772523
Brief Title
Control and Intervention Programme on Alzheimer's Disease Risk Factors
Acronym
ALFAlife
Official Title
Control and Intervention Programme on Alzheimer's Disease Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Primary Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
409 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Lifestyle recommendations
Intervention Description
Dietary, and physical, cognitive and social activity recommendations
Primary Outcome Measure Information:
Title
Change in Short Version of the Minnesota Leisure Time Physical Activity Questionnaire
Time Frame
1 year; change between baseline and one year after
Title
Change in 14-item mediterranean diet Questionnaire
Time Frame
1 year; change between baseline and one year after
Title
Change in Lifestyle Activities Questionnaire (LAQ)
Time Frame
1 year; change between baseline and one year after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Barcelonabeta Brain Research Center
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08005
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Control and Intervention Programme on Alzheimer's Disease Risk Factors
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