Cognitive Health Promotion Project in the Community

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.

Study Overview

• Status: Completed
• Conditions: Dietary Modification; Alteration of Cognitive Function
• Intervention / Treatment: Behavioral: Lifestyle Counseling Usual Care; Behavioral: Lifestyle Counseling Telephone, Bimonth; Behavioral: Lifestyle Counseling Telephone, Month; Behavioral: Lifestyle Counseling Visit, Bimonth; Behavioral: Lifestyle Counseling Visit, Reward

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.

• Study Type: Interventional
• Enrollment (Actual): 1115
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle Counseling Usual Care; Usual care participants in the group A received no additional services.	Behavioral: Lifestyle Counseling Usual Care; Usual care participants in the group A received no additional services.; Other Names: Group A usual care
Experimental: Lifestyle Counseling Telephone, Bimonth; Participants in the group B received bimonthly telephonic care management based on manual.	Behavioral: Lifestyle Counseling Telephone, Bimonth; Participants in the group B received bimonthly telephonic care management based on manual.; Other Names: Group B bimonthly telephone
Experimental: 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.	Behavioral: 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.; Other Names: Group C monthly telephone
Experimental: Lifestyle Counseling Visit, Bimonth; Participants in the group D received health educator-initiated visit counseling bimonthly.	Behavioral: Lifestyle Counseling Visit, Bimonth; Participants in the group D received health educator-initiated visit counseling bimonthly.; Other Names: Group D bimonthly visit
Experimental: Lifestyle Counseling Visit, Reward; Participants in the group E received health educator-initiated visit counseling bimonthly and reward.	Behavioral: Lifestyle Counseling Visit, Reward; Participants in the group E received health educator-initiated visit counseling bimonthly and reward.; Other Names: Group E bimonthly visit and reward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Chang Hyung Hong, MD PhD, Ajou University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 12, 2009
• First Submitted That Met QC Criteria: November 12, 2009
• First Posted (Estimate): November 13, 2009

Study Record Updates

• Last Update Posted (Estimate): February 24, 2012
• Last Update Submitted That Met QC Criteria: January 19, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: activity; MMSE
• Other Study ID Numbers: AjouU