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Gray Matters Alzheimer's Disease Prevention Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290912
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Maria C Norton, PhD, 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Behavioral: Health education program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
Behavioral: Health education program
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).

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Picture Vocabulary [ Time Frame: up to 7 months ]
    Picture Vocabulary cognitive test score

  2. Flanker Inhibitory Control and Attention Test [ Time Frame: up to 7 months ]
    Flanker Inhibitory Control and Attention Test cognitive test score

  3. List Sorting Working Memory Test [ Time Frame: up to 7 months ]
    List Sorting Working Memory Test cognitive test score

  4. Oral Symbol Digit Test [ Time Frame: up to 7 months ]
    Oral Symbol Digit Test cognitive test score

  5. Montreal Cognitive Assessment [ Time Frame: up to 7 months ]
    Montreal Cognitive Assessment test score

  6. Rey Auditory Verbal Learning Test [ Time Frame: up to 7 months ]
    Rey Auditory Verbal Learning Test score

  7. Controlled Oral Word Association Test [ Time Frame: up to 7 months ]
    Controlled Oral Word Association Test score

  8. Blood pressure [ Time Frame: up to 7 months ]
    Systolic and diastolic blood pressure

  9. Body mass index [ Time Frame: up to 7 months ]
    Height and weight measurement for computing body mass index

  10. Insulin [ Time Frame: up to 7 months ]
    insulin from venipuncture blood sample

  11. Systemic inflammation [ Time Frame: up to 7 months ]
    C-reactive protein from venipuncture blood sample

  12. Skin carotenoid status [ Time Frame: 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

  13. Triglycerides [ Time Frame: up to 7 months ]
    triglycerides from venipuncture blood sample

  14. HDL Cholesterol [ Time Frame: up to 7 months ]
    High-density lipoprotein from venipuncture blood sample

  15. LDL Cholesterol [ Time Frame: up to 7 months ]
    Low-density lipoprotein from venipuncture blood sample

  16. Total cholesterol [ Time Frame: up to 7 months ]
    Total cholesterol from venipuncture blood sample


Secondary Outcome Measures :
  1. Depression [ Time Frame: up to 7 months ]
    Center for Epidemiologic Studies - Depression scale score

  2. Motivation [ Time Frame: up to 7 months ]
    Situational Motivation Scale score

  3. Sleep Quality [ Time Frame: up to 7 months ]
    Pittsburgh Sleep Quality Index scale score

  4. Stress [ Time Frame: up to 7 months ]
    Perceived Stress Scale score

  5. Emotional Support [ Time Frame: up to 7 months ]
    Emotional Support subscale from the NIH Toolbox measures for social engagement

  6. Friendship [ Time Frame: up to 7 months ]
    Friendship subscale from the NIH Toolbox measures for social engagement

  7. Hostility [ Time Frame: up to 7 months ]
    Hostility subscale from the NIH Toolbox measures for social engagement

  8. Loneliness [ Time Frame: up to 7 months ]
    Loneliness subscale from the NIH Toolbox measures for social engagement

  9. Physical Activity - Moderate [ Time Frame: up to 7 months ]
    self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)

  10. Physical Activity - Vigorous [ Time Frame: up to 7 months ]
    self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)

  11. Nutrition [ Time Frame: up to 7 months ]
    Diet History Questionnaire

  12. Readiness for Change [ Time Frame: up to 7 months ]
    Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale

  13. Metacognition [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290912


Sponsors and Collaborators
Utah State University
Investigators
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Principal Investigator: Maria C Norton, PhD Utah State University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria C Norton, PhD, Professor, Utah State University
ClinicalTrials.gov Identifier: NCT02290912    
Other Study ID Numbers: 5606
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Keywords provided by Maria C Norton, PhD, Utah State University:
Alzheimer's disease prevention lifestyle intervention
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders