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Completed

NCT Number: NCT02290912

Gray Matters Alzheimer's Disease Prevention Intervention

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Education Program

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Utah State University

Other

Registry information

Official study title

Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2014
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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