Passport to Brain Wellness in Sedentary Adults
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

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.
    

Intervention name(s): Guided; Self-directed
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach; Received study materials but no phone coaching
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Interactive phone-based intervention with written materials; Older adults; Physical activity; Cognitive stimulation; Social engagement