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Alzheimer's DiseaseNCT02290912

Gray Matters Alzheimer's Disease Prevention Intervention

A study testing Health education program in people with Alzheimer's Disease, run by Utah State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Health education program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
No sites listed yet
Study dates
Apr 2014to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age
  • Residing or working in Cache County Utah
  • Possessing smart phone or tablet

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Health education program
Keywords
Alzheimer's disease prevention lifestyle intervention
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health education programBehavioural

    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).

Study groups in NCT02290912
Study groupRoleWhat they receive
TreatmentExperimentalHealth education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology
Receives: Behavioral: Health education program
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Picture Vocabulary

    Picture Vocabulary cognitive test score

    Measured: up to 7 months

  2. Flanker Inhibitory Control and Attention Test

    Flanker Inhibitory Control and Attention Test cognitive test score

    Measured: up to 7 months

  3. List Sorting Working Memory Test

    List Sorting Working Memory Test cognitive test score

    Measured: up to 7 months

  4. Oral Symbol Digit Test

    Oral Symbol Digit Test cognitive test score

    Measured: up to 7 months

  5. Montreal Cognitive Assessment

    Montreal Cognitive Assessment test score

    Measured: up to 7 months

  6. Rey Auditory Verbal Learning Test

    Rey Auditory Verbal Learning Test score

    Measured: up to 7 months

  7. Controlled Oral Word Association Test

    Controlled Oral Word Association Test score

    Measured: up to 7 months

  8. Blood pressure

    Systolic and diastolic blood pressure

    Measured: up to 7 months

  9. Body mass index

    Height and weight measurement for computing body mass index

    Measured: up to 7 months

  10. Insulin

    insulin from venipuncture blood sample

    Measured: up to 7 months

  11. Systemic inflammation

    C-reactive protein from venipuncture blood sample

    Measured: up to 7 months

  12. 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

    Measured: up to 7 months

  13. Triglycerides

    triglycerides from venipuncture blood sample

    Measured: up to 7 months

  14. HDL Cholesterol

    High-density lipoprotein from venipuncture blood sample

    Measured: up to 7 months

  15. LDL Cholesterol

    Low-density lipoprotein from venipuncture blood sample

    Measured: up to 7 months

  16. Total cholesterol

    Total cholesterol from venipuncture blood sample

    Measured: up to 7 months

Secondary outcomes (13)

  1. Depression

    Center for Epidemiologic Studies - Depression scale score

    Measured: up to 7 months

  2. Motivation

    Situational Motivation Scale score

    Measured: up to 7 months

  3. Sleep Quality

    Pittsburgh Sleep Quality Index scale score

    Measured: up to 7 months

  4. Stress

    Perceived Stress Scale score

    Measured: up to 7 months

  5. Emotional Support

    Emotional Support subscale from the NIH Toolbox measures for social engagement

    Measured: up to 7 months

  6. Friendship

    Friendship subscale from the NIH Toolbox measures for social engagement

    Measured: up to 7 months

  7. Hostility

    Hostility subscale from the NIH Toolbox measures for social engagement

    Measured: up to 7 months

  8. Loneliness

    Loneliness subscale from the NIH Toolbox measures for social engagement

    Measured: up to 7 months

  9. Physical Activity - Moderate

    self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)

    Measured: up to 7 months

  10. Physical Activity - Vigorous

    self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)

    Measured: up to 7 months

  11. Nutrition

    Diet History Questionnaire

    Measured: up to 7 months

  12. Readiness for Change

    Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale

    Measured: up to 7 months

  13. 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

    Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02290912
Sponsor's protocol ID
5606
Status last verified
Dec 2015
First submitted
6 Nov 2014
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27485822

Questions about this trial

What is this clinical trial studying?

A study testing Health education program in people with Alzheimer's Disease, run by Utah State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Picture Vocabulary (time frame: up to 7 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290912, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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