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Risk Reduction BehaviorNCT03900156

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

A study testing goal-setting in people with Risk Reduction Behavior and Reduce Risk of Dementia, run by Tzu-Ting Huang at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
What is being tested?
goal-setting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteTaiwan
Study dates
14 Apr 2019to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • can't speak chinese

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung University

    Taoyuan, 333

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
goal-setting
Medical subject headings
Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • goal-settingOther

    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.

Study groups in NCT03900156
Study groupRoleWhat they receive
comparison groupNo interventionThe CG received no extra care.
Intervention GroupExperimentalIntervention 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)
Receives: Other: goal-setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognition

    Mini-Mental State Examination

    Measured: 5 minutes

  2. cognition

    Montreal Cognitive Assessment

    Measured: 10 minutes

  3. objective parameters

    systolic blood pressure

    Measured: 2 minutes

  4. low-density-lipoprotein

    low-density-lipoprotein

    Measured: 1 minutes

  5. fasting blood sugar

    fasting blood sugar

    Measured: 1 minutes

  6. body mass index

    body mass index

    Measured: 1 minutes

  7. waist-hip ratio

    waist-hip ratio

    Measured: 1 minutes

Secondary outcomes (6)
  1. physical activity scale for the elderly

    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).

    Measured: 5 minutes

  2. Senior fitness test

    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.

    Measured: 15 minutes

  3. Mediterranean Diet Adherence Screener

    MEDAS. Schröder et al., 2011

    Measured: 5 minutes

  4. Geriatric Depression Scale-15

    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.

    Measured: 5 minutes

  5. University of California, Los Angeles, Loneliness Scale

    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").

    Measured: 5 minutes

  6. control, autonomy, self-realization, pleasure-19

    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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2019
  2. Study start14 Apr 2019
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03900156
Sponsor's protocol ID
201701926B0
Status last verified
Jul 2020
First submitted
14 Mar 2019
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing goal-setting in people with Risk Reduction Behavior and Reduce Risk of Dementia, run by Tzu-Ting Huang at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognition (time frame: 5 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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