- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00979446
Passport to Brain Wellness in Sedentary Adults
Developing a Multi-Domain Intervention to Maintain Cognitive Health in Sedentary Adults Ages 60 - 80
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Bloomington, Minnesota, United States, 55425
- HealthPartners Research Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Guided
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Six months after the baseline visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian C Martinson, PhD, HealthPartners Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-024S2
- 3R01AG023410-05S2 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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