Gray Matters Alzheimer's Disease Prevention Intervention
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health education program
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer's Disease focused on measuring Alzheimer's disease prevention lifestyle intervention
Eligibility Criteria
Inclusion Criteria:
- Age
- Residing or working in Cache County Utah
- Possessing smart phone or tablet
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
No intervention
Outcomes
Primary Outcome Measures
Picture Vocabulary
Picture Vocabulary cognitive test score
Flanker Inhibitory Control and Attention Test
Flanker Inhibitory Control and Attention Test cognitive test score
List Sorting Working Memory Test
List Sorting Working Memory Test cognitive test score
Oral Symbol Digit Test
Oral Symbol Digit Test cognitive test score
Montreal Cognitive Assessment
Montreal Cognitive Assessment test score
Rey Auditory Verbal Learning Test
Rey Auditory Verbal Learning Test score
Controlled Oral Word Association Test
Controlled Oral Word Association Test score
Blood pressure
Systolic and diastolic blood pressure
Body mass index
Height and weight measurement for computing body mass index
Insulin
insulin from venipuncture blood sample
Systemic inflammation
C-reactive protein from venipuncture blood sample
Skin carotenoid status
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
triglycerides from venipuncture blood sample
HDL Cholesterol
High-density lipoprotein from venipuncture blood sample
LDL Cholesterol
Low-density lipoprotein from venipuncture blood sample
Total cholesterol
Total cholesterol from venipuncture blood sample
Secondary Outcome Measures
Depression
Center for Epidemiologic Studies - Depression scale score
Motivation
Situational Motivation Scale score
Sleep Quality
Pittsburgh Sleep Quality Index scale score
Stress
Perceived Stress Scale score
Emotional Support
Emotional Support subscale from the NIH Toolbox measures for social engagement
Friendship
Friendship subscale from the NIH Toolbox measures for social engagement
Hostility
Hostility subscale from the NIH Toolbox measures for social engagement
Loneliness
Loneliness subscale from the NIH Toolbox measures for social engagement
Physical Activity - Moderate
self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
Physical Activity - Vigorous
self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
Nutrition
Diet History Questionnaire
Readiness for Change
Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
Metacognition
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
Full Information
NCT ID
NCT02290912
First Posted
November 6, 2014
Last Updated
December 2, 2015
Sponsor
Utah State University
1. Study Identification
Unique Protocol Identification Number
NCT02290912
Brief Title
Gray Matters Alzheimer's Disease Prevention Intervention
Official Title
Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Utah State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease prevention lifestyle intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Health education program
Intervention Description
The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals. Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes "cafeteria style" (i.e. based on their individual preferences).
Primary Outcome Measure Information:
Title
Picture Vocabulary
Description
Picture Vocabulary cognitive test score
Time Frame
up to 7 months
Title
Flanker Inhibitory Control and Attention Test
Description
Flanker Inhibitory Control and Attention Test cognitive test score
Time Frame
up to 7 months
Title
List Sorting Working Memory Test
Description
List Sorting Working Memory Test cognitive test score
Time Frame
up to 7 months
Title
Oral Symbol Digit Test
Description
Oral Symbol Digit Test cognitive test score
Time Frame
up to 7 months
Title
Montreal Cognitive Assessment
Description
Montreal Cognitive Assessment test score
Time Frame
up to 7 months
Title
Rey Auditory Verbal Learning Test
Description
Rey Auditory Verbal Learning Test score
Time Frame
up to 7 months
Title
Controlled Oral Word Association Test
Description
Controlled Oral Word Association Test score
Time Frame
up to 7 months
Title
Blood pressure
Description
Systolic and diastolic blood pressure
Time Frame
up to 7 months
Title
Body mass index
Description
Height and weight measurement for computing body mass index
Time Frame
up to 7 months
Title
Insulin
Description
insulin from venipuncture blood sample
Time Frame
up to 7 months
Title
Systemic inflammation
Description
C-reactive protein from venipuncture blood sample
Time Frame
up to 7 months
Title
Skin carotenoid status
Description
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
Time Frame
up to 7 months
Title
Triglycerides
Description
triglycerides from venipuncture blood sample
Time Frame
up to 7 months
Title
HDL Cholesterol
Description
High-density lipoprotein from venipuncture blood sample
Time Frame
up to 7 months
Title
LDL Cholesterol
Description
Low-density lipoprotein from venipuncture blood sample
Time Frame
up to 7 months
Title
Total cholesterol
Description
Total cholesterol from venipuncture blood sample
Time Frame
up to 7 months
Secondary Outcome Measure Information:
Title
Depression
Description
Center for Epidemiologic Studies - Depression scale score
Time Frame
up to 7 months
Title
Motivation
Description
Situational Motivation Scale score
Time Frame
up to 7 months
Title
Sleep Quality
Description
Pittsburgh Sleep Quality Index scale score
Time Frame
up to 7 months
Title
Stress
Description
Perceived Stress Scale score
Time Frame
up to 7 months
Title
Emotional Support
Description
Emotional Support subscale from the NIH Toolbox measures for social engagement
Time Frame
up to 7 months
Title
Friendship
Description
Friendship subscale from the NIH Toolbox measures for social engagement
Time Frame
up to 7 months
Title
Hostility
Description
Hostility subscale from the NIH Toolbox measures for social engagement
Time Frame
up to 7 months
Title
Loneliness
Description
Loneliness subscale from the NIH Toolbox measures for social engagement
Time Frame
up to 7 months
Title
Physical Activity - Moderate
Description
self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)
Time Frame
up to 7 months
Title
Physical Activity - Vigorous
Description
self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)
Time Frame
up to 7 months
Title
Nutrition
Description
Diet History Questionnaire
Time Frame
up to 7 months
Title
Readiness for Change
Description
Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale
Time Frame
up to 7 months
Title
Metacognition
Description
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
Time Frame
up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age
Residing or working in Cache County Utah
Possessing smart phone or tablet
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Norton, PhD
Organizational Affiliation
Utah State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27485822
Citation
Hartin PJ, Nugent CD, McClean SI, Cleland I, Tschanz JT, Clark CJ, Norton MC. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Aug 2;4(3):e93. doi: 10.2196/mhealth.4878.
Results Reference
derived
Learn more about this trial
Gray Matters Alzheimer's Disease Prevention Intervention
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