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.
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
- Conditions the study is for
- Risk Reduction Behavior, Reduce Risk of Dementia
- 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.
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.
- Conditions
- Risk Reduction Behavior, Reduce Risk of Dementia
- 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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: goal-setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
Mini-Mental State Examination
Measured: 5 minutes
cognition
Montreal Cognitive Assessment
Measured: 10 minutes
objective parameters
systolic blood pressure
Measured: 2 minutes
low-density-lipoprotein
low-density-lipoprotein
Measured: 1 minutes
fasting blood sugar
fasting blood sugar
Measured: 1 minutes
body mass index
body mass index
Measured: 1 minutes
waist-hip ratio
waist-hip ratio
Measured: 1 minutes
Secondary outcomes (6)
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
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
Mediterranean Diet Adherence Screener
MEDAS. Schröder et al., 2011
Measured: 5 minutes
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
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
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.
- First posted2 Apr 2019
- Study start14 Apr 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tzu-Ting Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tzu-Ting Huang, Chang Gung Memorial Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Goal-setting With Mentoring Lifestyle Modification Intervention to Reduce Risk of Dementia in Later Life
- ClinicalTrials.gov ID
- NCT03900156
- Acronym / sponsor ID
- 201701926B0
- Conditions
- Risk Reduction Behavior, Reduce Risk of Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Tzu-Ting HuangUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| comparison group | No intervention | –The CG received no extra care. |
| Intervention Group | Experimental | Other: goal-settingIntervention 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) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- can't speak chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| goal-settingThe 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. | Other | Intervention Group |
Primary outcome
cognition
Time frame: 5 minutes
Mini-Mental State Examination
cognition
Time frame: 10 minutes
Montreal Cognitive Assessment
objective parameters
Time frame: 2 minutes
systolic blood pressure
low-density-lipoprotein
Time frame: 1 minutes
low-density-lipoprotein
fasting blood sugar
Time frame: 1 minutes
fasting blood sugar
body mass index
Time frame: 1 minutes
body mass index
waist-hip ratio
Time frame: 1 minutes
waist-hip ratio
6 secondary outcomes
physical activity scale for the elderly
Time frame: 5 minutes
Senior fitness test
Time frame: 15 minutes
Mediterranean Diet Adherence Screener
Time frame: 5 minutes
Geriatric Depression Scale-15
Time frame: 5 minutes
University of California, Los Angeles, Loneliness Scale
Time frame: 5 minutes
control, autonomy, self-realization, pleasure-19
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.