Passport to Brain Wellness in Sedentary Adults

September 17, 2009 updated by: HealthPartners Institute

Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The initial aim of the project was to recruit 20 cognitively intact adults ages 60-80 from one health plan, assessing them at baseline with respect to their cognitive health, multiple lifestyle factors, biomarkers and biometrics, engaging them in a 12 week lifestyle intervention and re-assessing them immediately post-intervention.

Specific Aims

  1. Design a multi-domain, lifestyle intervention to increase PA, social integration and cognitive stimulation, and improve nutrition in sedentary, cognitively intact adults, age 60 to 80.

  2. Assess the feasibility of implementing such a multi-domain intervention:

    1. recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a health plan,
    2. obtain baseline measures of cognitive function, physical and social activities, mood, nutrition, height and weight, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation,
    3. engage these adults in a 4 month pilot of this multi-domain lifestyle intervention with a phone coach and
    4. obtain post-intervention measures of cognitive functioning, physical and social activities, mood, nutrition, vascular risk factors of blood pressure and fasting lipids, and biomarkers of inflammation.

After successfully recruiting the first 20 subjects, we determined that the grant budget would allow us to enrich the study by recruiting 40 more subjects. A second, comparison arm was added. The first study arm received the intervention as described above. Subjects assigned (by chance) to the comparison arm received study materials but did not have a phone coach assigned. The additional 40 subjects were genotyped with respect to the apolipoprotein E4 (apoE4) allele.

This feasibility pilot of an evidence-based intervention targets protective lifestyle factors related to cognitive health, including physical and social activities, cognitive stimulation and nutrition. The information gained on intervention design, implementation, and subject recruitment, will guide development of a full-scale intervention study of primary prevention of cognitive decline.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartners Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Guided
Behavioral: Guided
Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
ACTIVE_COMPARATOR: Self-directed
Behavioral: Self-directed
Received study materials but no phone coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
Time Frame: Six months after the baseline visit
Six months after the baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Brian C Martinson, PhD, HealthPartners Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

September 16, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (ESTIMATE)

September 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-024S2
  • 3R01AG023410-05S2 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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