Cognitive Health Promotion Project in the Community

Dietary Modification Clinical Trial

Official title:

Cognitive Health Promotion Project in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012947
• Other study ID #: AjouU
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2009
• Last updated: January 19, 2012
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: January 2012
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1115
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alteration of Cognitive Function
• Dietary Modification

Intervention

Behavioral:
• Lifestyle Counseling Usual Care
Usual care participants in the group A received no additional services.
• Lifestyle Counseling Telephone, Bimonth
Participants in the group B received bimonthly telephonic care management based on manual.
• Lifestyle Counseling Telephone, Month
Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
• Lifestyle Counseling Visit, Bimonth
Participants in the group D received health educator-initiated visit counseling bimonthly.
• Lifestyle Counseling Visit, Reward
Participants in the group E received health educator-initiated visit counseling bimonthly and reward.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 18 months	No