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Gray Matters Alzheimer's Disease Prevention Intervention

NCT ID: NCT02290912

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

Health education program; informational website, experiential classes in various help domains, custom smart phone application, and wearable technology

Group Type EXPERIMENTAL

Health education program

Intervention Type 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).

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Utah State University

OTHER

Sponsor Role lead

Responsible Party

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Maria C Norton, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria C Norton, PhD

Role: PRINCIPAL_INVESTIGATOR

Utah State University

References

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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.

Reference Type DERIVED
PMID: 27485822 (View on PubMed)

Other Identifiers

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5606

Identifier Type: -

Identifier Source: org_study_id