NCT00979446

Brief Summary

Numerous modifiable lifestyle factors have been identified that may affect the risk of older adults developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Evidence suggests that interventions to reduce risk factors and enhance protective factors would be beneficial in slowing cognitive decline and decreasing the risk of incident MCI and AD. The overall objective of this pilot study, funded as a supplement to Keep Active Minnesota (KAM) (03-024; R01-AG023410) is to develop and test the feasibility of conducting a multi-domain intervention to maintain cognitive health in adults ages 60-80 with the goal of reducing the incidence of and slowing progression to MCI and other more severe forms of cognitive decline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

11 months

First QC Date

September 16, 2009

Last Update Submit

September 17, 2009

Conditions

Keywords

Interactive phone-based intervention with written materialsOlder adultsPhysical activityCognitive stimulationSocial engagement

Outcome Measures

Primary Outcomes (1)

  • We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.

    Six months after the baseline visit

Study Arms (2)

Guided

EXPERIMENTAL
Behavioral: Guided

Self-directed

ACTIVE COMPARATOR
Behavioral: Self-directed

Interventions

GuidedBEHAVIORAL

Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach

Guided
Self-directedBEHAVIORAL

Received study materials but no phone coaching

Self-directed

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 60 and 80
  • Have had HealthPartners insurance for 11 out of the 12 months prior to recruitment
  • Engage in less than 90 minutes per week of moderate intensity physical activity
  • Works or volunteers 20 hours total per week or less
  • Telephone Interview for Cognitive Status (TICS) score of 31 and above

You may not qualify if:

  • Modified Charlson scores \>=3 (calculated using prior year diagnoses)
  • Nonskin cancer
  • Congestive heart failure
  • Coronary heart disease
  • Psychotic Illness
  • Substance abuse
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Bloomington, Minnesota, 55425, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Brian C Martinson, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 18, 2009

Study Start

June 1, 2008

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations