Passport to Brain Wellness in Sedentary Adults
Mild Cognitive Impairment
|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|
- 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 ]
|Study Start Date:||June 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Engaged in a 4 month pilot of a multi-domain lifestyle intervention with a phone coach
|Active Comparator: Self-directed||
Received study materials but no phone coaching
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979446
|United States, Minnesota|
|HealthPartners Research Foundation|
|Bloomington, Minnesota, United States, 55425|
|Principal Investigator:||Brian C Martinson, PhD||HealthPartners Institute|