Passport to Brain Wellness in Sedentary Adults

This study has been completed.
Sponsor:
Information provided by:
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00979446
First received: September 16, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Alzheimer's Disease
Behavioral: Guided
Behavioral: Self-directed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

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. [ Time Frame: Six months after the baseline visit ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979446

Locations
United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Brian C Martinson, PhD HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: Brian C. Martinson, PhD, Senior Research Investigator, HealthPartners Research Foundation
ClinicalTrials.gov Identifier: NCT00979446     History of Changes
Other Study ID Numbers: 03-024S2, 3 R01 AG023410-05S2
Study First Received: September 16, 2009
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by HealthPartners Institute for Education and Research:
Interactive phone-based intervention with written materials
Older adults
Physical activity
Cognitive stimulation
Social engagement

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014