Gray Matters Alzheimer's Disease Prevention Intervention
- Conditions
- Alzheimer's Disease
- Interventions
- Behavioral: Health education program
- Registration Number
- NCT02290912
- Lead Sponsor
- Utah State University
- Brief Summary
This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.
- Detailed Description
This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years. Participants are randomized to treatment or control condition. The intervention, spanning a six month period, is an evidence-based health education program.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- Age
- Residing or working in Cache County Utah
- Possessing smart phone or tablet
- Dementia
- Pregnancy
- Untreated chronic major depression or other psychiatric condition
- Body mass index > 41
- Heart or stroke in prior 6 weeks
- Active cancer treatment
- Unwillingness to seek medical help when serious condition identified at intake
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Health education program Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
- Primary Outcome Measures
Name Time Method Picture Vocabulary up to 7 months Picture Vocabulary cognitive test score
Oral Symbol Digit Test up to 7 months Oral Symbol Digit Test cognitive test score
Montreal Cognitive Assessment up to 7 months Montreal Cognitive Assessment test score
Rey Auditory Verbal Learning Test up to 7 months Rey Auditory Verbal Learning Test score
Blood pressure up to 7 months Systolic and diastolic blood pressure
LDL Cholesterol up to 7 months Low-density lipoprotein from venipuncture blood sample
Flanker Inhibitory Control and Attention Test up to 7 months Flanker Inhibitory Control and Attention Test cognitive test score
List Sorting Working Memory Test up to 7 months List Sorting Working Memory Test cognitive test score
Controlled Oral Word Association Test up to 7 months Controlled Oral Word Association Test score
Body mass index up to 7 months Height and weight measurement for computing body mass index
Insulin up to 7 months insulin from venipuncture blood sample
Skin carotenoid status up to 7 months Biophotonic device that shines a light-emitting diode (LED) light at a site on the palm, to measure the skin carotenoid level in units of Raman counts
Triglycerides up to 7 months triglycerides from venipuncture blood sample
HDL Cholesterol up to 7 months High-density lipoprotein from venipuncture blood sample
Systemic inflammation up to 7 months C-reactive protein from venipuncture blood sample
Total cholesterol up to 7 months Total cholesterol from venipuncture blood sample
- Secondary Outcome Measures
Name Time Method Motivation up to 7 months Situational Motivation Scale score
Sleep Quality up to 7 months Pittsburgh Sleep Quality Index scale score
Depression up to 7 months Center for Epidemiologic Studies - Depression scale score
Physical Activity - Moderate up to 7 months self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
Physical Activity - Vigorous up to 7 months self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
Metacognition up to 7 months Total score from a set of seven items (1=much worse to 5=much better), comparing current memory to how it was three years ago, adapted from a questionnaire of functional ability
Loneliness up to 7 months Loneliness subscale from the NIH Toolbox measures for social engagement
Stress up to 7 months Perceived Stress Scale score
Emotional Support up to 7 months Emotional Support subscale from the NIH Toolbox measures for social engagement
Friendship up to 7 months Friendship subscale from the NIH Toolbox measures for social engagement
Hostility up to 7 months Hostility subscale from the NIH Toolbox measures for social engagement
Readiness for Change up to 7 months Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
Nutrition up to 7 months Diet History Questionnaire