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Passport to Brain Wellness in Sedentary Adults

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided
Self-directed
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Interactive phone-based intervention with written materials, Older adults, Physical activity, Cognitive stimulation, Social engagement

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • HealthPartners Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided

Self-directed

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2009
Last Updated
September 17, 2009
Sponsor
HealthPartners Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00979446
Brief Title
Passport to Brain Wellness in Sedentary Adults
Official Title
Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
HealthPartners Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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. Assess the feasibility of implementing such a multi-domain intervention: recruit and screen 20 sedentary, cognitively intact adults aged 60 to 80 from a health plan, 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, engage these adults in a 4 month pilot of this multi-domain lifestyle intervention with a phone coach and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease
Keywords
Interactive phone-based intervention with written materials, Older adults, Physical activity, Cognitive stimulation, Social engagement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided
Arm Type
Experimental
Arm Title
Self-directed
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Guided
Intervention Description
Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
Intervention Type
Behavioral
Intervention Name(s)
Self-directed
Intervention Description
Received study materials but no phone coaching
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian C Martinson, PhD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Research Foundation
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

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Passport to Brain Wellness in Sedentary Adults

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