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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
Utah State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer's Disease focused on measuring Alzheimer's disease prevention lifestyle intervention

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 6, 2014
    Last Updated
    December 2, 2015
    Sponsor
    Utah State University
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    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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