Alteration of Cognitive Function, Dietary Modification
Conditions
Keywords
MMSE, activity
Brief summary
This study was based on baseline data derived from a large prospective study called the Suwon Project (SP), a cohort comprising random clustering samples of elderly people, all of whom are ethnic Koreans aged over 60 years.
Detailed description
There is growing evidence supporting the protective effect of health behaviors against cognitive decline and dementia in older persons. With this increasing evidence and a better understanding of the underlying mechanisms, lifestyle modification is likely to be increasingly promoted as a convincing strategy for maintaining cognitive health in later life. The study protocol included cognitive screening through the Korean version of the Mini-Mental State Examination (K-MMSE), which has been validated for the Korean-speaking population ({YW, 1997 #88}Kang YW et al., 1997), recording of the subject's medical history. A Korean study in the community defined the cut-off point of K-MMSE score during the screening of dementia as 17/18 points; the sensitivity and specificity of the findings were 91% and 86%, respectively ({YW, 1997 #88}Kim et al., 2003). Based on these results, we defined cognitive impairment (CI) as the group that had a K-MMSE score lower than 17, and not cognitive impairment (NCI) was defined as the group that had a K-MMSE score higher than 18.
Interventions
BEHAVIORALLifestyle Counseling Usual Care
Usual care participants in the group A received no additional services.
BEHAVIORALLifestyle Counseling Telephone, Bimonth
Participants in the group B received bimonthly telephonic care management based on manual.
BEHAVIORALLifestyle Counseling Telephone, Month
Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
BEHAVIORALLifestyle Counseling Visit, Bimonth
Participants in the group D received health educator-initiated visit counseling bimonthly.
BEHAVIORALLifestyle Counseling Visit, Reward
Participants in the group E received health educator-initiated visit counseling bimonthly and reward.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* more than 60 years old
Exclusion criteria
* those with a history of significant hearing or visual impairment that rendered participation in the interview difficult * those with a history of neurological disorders (e.g., stroke, Parkinson's disease, or active epilepsy) * those with psychiatric illness (e.g., schizophrenia, mental retardation, severe depression, or mania) * those taking psychotropic medications, or those with significant alcohol and other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | baseline and 18 months | The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation. |
Participant flow
Recruitment details
The trial was conducted from August 2008 to December 2010 at a geriatric mental health community center in Suwon, south Korea. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.
Pre-assignment details
Criteria for exclusion included severe visual or hearing impairment and a previous diagnosis of idiopathic Parkinson's disease, liver disease, alcoholism, or known terminal illness. Prior to initiating the study, we obtained a list of all senior citizen centers. A random number table was used to classify the intervention group.
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Counseling A,Usual Care Usual care participants received no additional services. | 212 |
| Lifestyle Counseling B, Telephone, Bimonthly Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal. | 215 |
| Lifestyle Counseling C, Telephone, Monthly Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B. | 241 |
| Lifestyle Counseling D, Visit, Bimonthly Participants in the group D received health educator-initiated visit counseling bimonthly. | 211 |
| Lifestyle Counseling E, Visit, Reward Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward. | 236 |
| Total | 1,115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 131 | 135 | 130 | 118 | 142 |
Baseline characteristics
| Characteristic | Lifestyle Counseling B, Telephone, Bimonthly | Lifestyle Counseling C, Telephone, Monthly | Lifestyle Counseling D, Visit, Bimonthly | Lifestyle Counseling A,Usual Care | Lifestyle Counseling E, Visit, Reward | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 215 Participants | 241 Participants | 211 Participants | 212 Participants | 236 Participants | 1115 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 76.5 years STANDARD_DEVIATION 2.9 | 77.3 years STANDARD_DEVIATION 1.7 | 77.9 years STANDARD_DEVIATION 3.7 | 77.5 years STANDARD_DEVIATION 1.9 | 76.7 years STANDARD_DEVIATION 2.1 | 77.1 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment Korea, Republic of | 215 participants | 241 participants | 211 participants | 212 participants | 236 participants | 1115 participants |
| Sex: Female, Male Female | 174 Participants | 188 Participants | 170 Participants | 157 Participants | 172 Participants | 861 Participants |
| Sex: Female, Male Male | 41 Participants | 53 Participants | 41 Participants | 55 Participants | 64 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 212 | 0 / 215 | 0 / 241 | 0 / 211 | 0 / 236 |
| serious Total, serious adverse events | 0 / 212 | 0 / 215 | 0 / 241 | 0 / 211 | 0 / 236 |
Outcome results
Primary
Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group
The mini-mental state examination (MMSE) or Folstein test is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It ranges from 0 to 30 points. The higher scores mean better outcome. It is also used to estimate the severity of cognitive impairment at a given point in time and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. In the time span of about 10 minutes it samples various functions including arithmetic, memory and orientation.
Time frame: baseline and 18 months
Population: The location of the survey was Suwon City, with a population of 1 million, located adjacent to Seoul, the nation's capital. The center, which has been established since 2008 and has outreach sites throughout the districts, provides a range of social, health, educational, and recreational services for users of elderly groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling A,Usual Care | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 23.3 units on a scale | Standard Deviation 2.3 |
| Lifestyle Counseling B, Telephone, Bimonthly | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 23.8 units on a scale | Standard Deviation 2.1 |
| Lifestyle Counseling C, Telephone, Monthly | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 23.1 units on a scale | Standard Deviation 1 |
| Lifestyle Counseling D, Visit, Bimonthly | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 23.7 units on a scale | Standard Deviation 1.4 |
| Lifestyle Counseling E, Visit, Reward | Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group | 24.2 units on a scale | Standard Deviation 0.7 |