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

• ClinicalTrials.gov Identifier: NCT03900156
• Recruitment Status: Completed
• First Posted: April 2, 2019
• Last Update Posted: July 15, 2020
• Sponsor: Tzu-Ting Huang
• Information provided by (Responsible Party): Tzu-Ting Huang, Chang Gung Memorial Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Risk Reduction Behavior; Reduce Risk of Dementia	Other: goal-setting	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life
• Actual Study Start Date: April 14, 2019
• Actual Primary Completion Date: June 30, 2020
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: comparison group; The CG received no extra care.
Experimental: Intervention Group; 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)	Other: goal-setting; 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.

Outcome Measures

Primary Outcome Measures :

1. cognition [ Time Frame: 5 minutes ]
   Mini-Mental State Examination
2. cognition [ Time Frame: 10 minutes ]
   Montreal Cognitive Assessment
3. objective parameters [ Time Frame: 2 minutes ]
   systolic blood pressure
4. low-density-lipoprotein [ Time Frame: 1 minutes ]
   low-density-lipoprotein
5. fasting blood sugar [ Time Frame: 1 minutes ]
   fasting blood sugar
6. body mass index [ Time Frame: 1 minutes ]
   body mass index
7. waist-hip ratio [ Time Frame: 1 minutes ]
   waist-hip ratio

Secondary Outcome Measures :

1. physical activity scale for the elderly [ Time Frame: 5 minutes ]

   The first page of the questionnaire provides general instructions and shows an example of a completed item. Respondents should be encouraged to answer each item by circling the correct response. All items refer to activities performed in the previous seven days. "Never" and "No" responses should always be marked to indicate any activities the respondent did not perform during that period.

   The leisure activity items require respondents to first report the number of days per week the activity was performed and then the number of hours per day. Space is also provided for respondents to record the types of activities in which they engaged. These reports should be reviewed before computing PASE scores to ensure that specific sports and recreational activities have been recorded in the appropriate categories.

   In this sample scores ranged from 0 to 361. The mean score was 102.9 (standard deviation = 64.1); the median was 90. Mean scores (and standard deviations).

2. Senior fitness test [ Time Frame: 15 minutes ]

   The Senior Fitness Test was developed as part of the LifeSpan Wellness Program at Fullerton University, by Dr. Roberta Rikli and Dr. Jessie Jones. As such, the test is sometimes known as the Fullerton Functional Test. It is a simple, easy-to-use battery of test items that assess the functional fitness of older adults. The test describes easy to understand and effective tests to measure aerobic fitness, strength and flexibility using minimal and inexpensive equipment.

   The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching. The tests were developed to be safe and enjoyable for older adults, while still meeting scientific standards for reliability and validity.

3. Mediterranean Diet Adherence Screener [ Time Frame: 5 minutes ]
   MEDAS. Schröder et al., 2011
4. Geriatric Depression Scale-15 [ Time Frame: 5 minutes ]

   A short-form GDS that consisted of 15 questions was the primary outcome measure (Sheikh and Yesavage, 1986). Scores of 0-4 are considered normal; 5-8 indicates mild depression; 9-11 indicates moderate depression; and 12-15 indicates severe depression.

   The Chinese version of the GDS-15 demonstrates high reliability (Liao et al., 1995); in this study, the Cronbach's a is .91.

5. University of California, Los Angeles, Loneliness Scale [ Time Frame: 5 minutes ]
   A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way").
6. control, autonomy, self-realization, pleasure-19 [ Time Frame: 5 minutes ]

   Description: The Quality of Life Scale (CASP-19) uses four domains (i.e., control, autonomy, pleasure and self-realization) to assess the quality of life in individuals in early old age.

   Number of items: 19, including 6 items for control, 5 items for autonomy, 4 items for pleasure and 4 items for self-realization.

   Example of statement/item: "I look forward to each day" Response options: 4-point Likert scale ranging from 0, "never" to 3, "often". Total score: Items are summed, yielding a range from 0 to 57 for the total score (domains are usually not used separately). Higher scores indicate higher levels of satisfaction of quality of life.

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Taiwan

Chang Gung University

Taoyuan, Taiwan, 333

Sponsors and Collaborators

Tzu-Ting Huang

More Information

• Responsible Party: Tzu-Ting Huang, Professor, School of Nursing, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03900156
• Other Study ID Numbers: 201701926B0
• First Posted: April 2, 2019
• Last Update Posted: July 15, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders