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临床试验/NCT03900156
NCT03900156已完成不适用

A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life

Tzu-Ting Huang1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
cognition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •can't speak chinese

研究组 & 干预措施

comparison group

No Intervention

The CG received no extra care.

Intervention Group

Experimental

Intervention 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)

干预措施: goal-setting (Other)

结局指标

主要结局

cognition

时间窗: 10 minutes

Montreal Cognitive Assessment

waist-hip ratio

时间窗: 1 minutes

waist-hip ratio

body mass index

时间窗: 1 minutes

body mass index

low-density-lipoprotein

时间窗: 1 minutes

low-density-lipoprotein

fasting blood sugar

时间窗: 1 minutes

fasting blood sugar

objective parameters

时间窗: 2 minutes

systolic blood pressure

cognition

时间窗: 5 minutes

Mini-Mental State Examination

次要结局

  • Mediterranean Diet Adherence Screener(5 minutes)
  • Geriatric Depression Scale-15(5 minutes)
  • control, autonomy, self-realization, pleasure-19(5 minutes)
  • physical activity scale for the elderly(5 minutes)
  • Senior fitness test(15 minutes)
  • University of California, Los Angeles, Loneliness Scale(5 minutes)

研究者

发起方
Tzu-Ting Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tzu-Ting Huang

Professor, School of Nursing

Chang Gung Memorial Hospital

研究点 (1)

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