Phase 1
N=1,115
Cognitive Health Promotion Project in the Community
Alteration of Cognitive Function · Dietary Modification
Bottom Line
View on ClinicalTrials.gov: NCT01012947 ↗Enrolled (actual)
1,115
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group — 23.3; 23.8; 23.1; 23.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lifestyle Counseling Usual Care (Behavioral); Lifestyle Counseling Telephone, Bimonth (Behavioral); Lifestyle Counseling Telephone, Month (Behavioral); Lifestyle Counseling Visit, Bimonth (Behavioral); Lifestyle Counseling Visit, Reward (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Ajou University School of Medicine
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Cognitive Function Measured by a Mini Mental State Examination Scores on a Scale According to Study Group |
23.3; 23.8; 23.1; 23.7; 24.2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01012947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.