Gray Matters Alzheimer's Disease Prevention Intervention

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Behavioral: Health education program

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Picture Vocabulary	Picture Vocabulary cognitive test score	up to 7 months
Flanker Inhibitory Control and Attention Test	Flanker Inhibitory Control and Attention Test cognitive test score	up to 7 months
List Sorting Working Memory Test	List Sorting Working Memory Test cognitive test score	up to 7 months
Oral Symbol Digit Test	Oral Symbol Digit Test cognitive test score	up to 7 months
Montreal Cognitive Assessment	Montreal Cognitive Assessment test score	up to 7 months
Rey Auditory Verbal Learning Test	Rey Auditory Verbal Learning Test score	up to 7 months
Controlled Oral Word Association Test	Controlled Oral Word Association Test score	up to 7 months
Blood pressure	Systolic and diastolic blood pressure	up to 7 months
Body mass index	Height and weight measurement for computing body mass index	up to 7 months
Insulin	insulin from venipuncture blood sample	up to 7 months
Systemic inflammation	C-reactive protein from venipuncture blood sample	up to 7 months
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	up to 7 months
Triglycerides	triglycerides from venipuncture blood sample	up to 7 months
HDL Cholesterol	High-density lipoprotein from venipuncture blood sample	up to 7 months
LDL Cholesterol	Low-density lipoprotein from venipuncture blood sample	up to 7 months
Total cholesterol	Total cholesterol from venipuncture blood sample	up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Center for Epidemiologic Studies - Depression scale score	up to 7 months
Motivation	Situational Motivation Scale score	up to 7 months
Sleep Quality	Pittsburgh Sleep Quality Index scale score	up to 7 months
Stress	Perceived Stress Scale score	up to 7 months
Emotional Support	Emotional Support subscale from the NIH Toolbox measures for social engagement	up to 7 months
Friendship	Friendship subscale from the NIH Toolbox measures for social engagement	up to 7 months
Hostility	Hostility subscale from the NIH Toolbox measures for social engagement	up to 7 months
Loneliness	Loneliness subscale from the NIH Toolbox measures for social engagement	up to 7 months
Physical Activity - Moderate	self-report question concerning # minutes per day doing moderate intensity physical activity (per Center for Disease Control definition)	up to 7 months
Physical Activity - Vigorous	self-report question concerning # minutes per day doing vigorous intensity physical activity (per Center for Disease Control definition)	up to 7 months
Nutrition	Diet History Questionnaire	up to 7 months
Readiness for Change	Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale	up to 7 months
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	up to 7 months

Collaborators and Investigators

• Sponsor: Utah State University
• Investigators: Principal Investigator: Maria C Norton, PhD, Utah State University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Alzheimer's disease prevention lifestyle intervention
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 5606