Clinical trial NCT03900156: A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life
Official title: A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Reduction Behavior
Reduce Risk of Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 94
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Lifestyle factors playing a role in the development of late-life cognitive decline may be modifiable. There is a need for robust evidence about the potential for prevention of cognitive decline through behavior change interventions.

This study involves the development, implementation and initial testing of a behavior change intervention. At the 1st year, a small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aim at promoting behavior change of personal modifiable risks for cognitive decline in the community for \>55 years with at least one of the 7 modifiable risk factors for dementia. These older participants in the community (n = 100) will be randomized to either control (had a discussion regarding health and daily activity) or goal-setting with mentoring (the goal-setting interview involving identification of up to five personal goals of personal modifiable risks). All participants will be reassessed after 12 months. The 2nd to the 5th year, is a multisite, prospective, RCT with 36 months intervention. Recruitment of 300 older people (≥55 years) with at least one of the 7 modifiable risk factors for dementia will take place in Northern Taiwan. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of dementia risk factors, with remote mentoring by a mentor.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* can't speak chinese

Primary outcomes:
measure: cognition
timeFrame: 5 minutes
measure: cognition
timeFrame: 10 minutes
measure: objective parameters
timeFrame: 2 minutes
measure: low-density-lipoprotein
timeFrame: 1 minutes
measure: fasting blood sugar
timeFrame: 1 minutes
measure: body mass index
timeFrame: 1 minutes
measure: waist-hip ratio
timeFrame: 1 minutes
Secondary outcomes:
measure: physical activity scale for the elderly
timeFrame: 5 minutes
measure: Senior fitness test
timeFrame: 15 minutes
measure: Mediterranean Diet Adherence Screener
timeFrame: 5 minutes
measure: Geriatric Depression Scale-15
timeFrame: 5 minutes
measure: University of California, Los Angeles, Loneliness Scale
timeFrame: 5 minutes
measure: control, autonomy, self-realization, pleasure-19
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: