A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life
1 other identifier
interventional
94
1 country
1
Brief Summary
This is a 5-year project. In the 1st year of this study, a pilot randomized controlled trial evaluating the feasibility and acceptability of a goal-setting behavior change intervention aim at reducing modifiable risk factors for preventing cognitive decline. The aim of 2nd to 5th year of this study to investigate whether this multidomain intervention to optimize self-management of cognitive decline risk factors in older individuals, delivered through a mentor- supported interactive internet platform, can reduce the risk of cognitive decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedStudy Start
First participant enrolled
April 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 15, 2020
July 1, 2020
1.2 years
March 14, 2019
July 14, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
cognition
Mini-Mental State Examination
5 minutes
cognition
Montreal Cognitive Assessment
10 minutes
objective parameters
systolic blood pressure
2 minutes
low-density-lipoprotein
low-density-lipoprotein
1 minutes
fasting blood sugar
fasting blood sugar
1 minutes
body mass index
body mass index
1 minutes
waist-hip ratio
waist-hip ratio
1 minutes
Secondary Outcomes (6)
physical activity scale for the elderly
5 minutes
Senior fitness test
15 minutes
Mediterranean Diet Adherence Screener
5 minutes
Geriatric Depression Scale-15
5 minutes
University of California, Los Angeles, Loneliness Scale
5 minutes
- +1 more secondary outcomes
Study Arms (2)
comparison group
NO INTERVENTIONThe CG received no extra care.
Intervention Group
EXPERIMENTALIntervention Group, goal-setting with follow-up, will have a structured goalsetting interview using the Bangor Goal-Setting Interview ; once goals are identified and clearly expressed in accordance with SMART principles (specific, measureable, achievable, realistic, and timed)
Interventions
The interviewer will have access to key information from the initial assessment such as details of identified risks. Areas where the participant would like to make changes or improvements will be identified and prioritized, and up to five specific, realistic and achievable goals will be identified.
Eligibility Criteria
You may qualify if:
- in Northern Taiwan
- at least one of the 8 modifiable risk factors for dementia (Hearing loss, Hypertension, Obesity, Smoking, Depression, Physical inactivity, Social isolation, and Diabetes)
- living independently
- in the local community
You may not qualify if:
- can't speak chinese
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tzu-Ting Huanglead
Study Sites (1)
Chang Gung University
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, School of Nursing
Study Record Dates
First Submitted
March 14, 2019
First Posted
April 2, 2019
Study Start
April 14, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
July 15, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share