Clinical trial NCT00979446: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Keywords: Interactive phone-based intervention with written materials
Older adults
Physical activity
Cognitive stimulation
Social engagement
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2009-09-18
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: We will use this pilot to determine the feasibility of carrying out a full-scale randomized trial to test the efficacy of our intervention.
timeFrame: Six months after the baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Brian C Martinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: