Gray Matters Alzheimer's Disease Prevention Intervention

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290912
• Other study ID #: 5606
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: December 2, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Picture Vocabulary	Picture Vocabulary cognitive test score	up to 7 months	No
Primary	Flanker Inhibitory Control and Attention Test	Flanker Inhibitory Control and Attention Test cognitive test score	up to 7 months	No
Primary	List Sorting Working Memory Test	List Sorting Working Memory Test cognitive test score	up to 7 months	No
Primary	Oral Symbol Digit Test	Oral Symbol Digit Test cognitive test score	up to 7 months	No
Primary	Montreal Cognitive Assessment	Montreal Cognitive Assessment test score	up to 7 months	No
Primary	Rey Auditory Verbal Learning Test	Rey Auditory Verbal Learning Test score	up to 7 months	No
Primary	Controlled Oral Word Association Test	Controlled Oral Word Association Test score	up to 7 months	No
Primary	Blood pressure	Systolic and diastolic blood pressure	up to 7 months	No
Primary	Body mass index	Height and weight measurement for computing body mass index	up to 7 months	No
Primary	Insulin	insulin from venipuncture blood sample	up to 7 months	Yes
Primary	Systemic inflammation	C-reactive protein from venipuncture blood sample	up to 7 months	Yes
Primary	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	No
Primary	Triglycerides	triglycerides from venipuncture blood sample	up to 7 months	Yes
Primary	HDL Cholesterol	High-density lipoprotein from venipuncture blood sample	up to 7 months	Yes
Primary	LDL Cholesterol	Low-density lipoprotein from venipuncture blood sample	up to 7 months	Yes
Primary	Total cholesterol	Total cholesterol from venipuncture blood sample	up to 7 months	Yes
Secondary	Depression	Center for Epidemiologic Studies - Depression scale score	up to 7 months	No
Secondary	Motivation	Situational Motivation Scale score	up to 7 months	No
Secondary	Sleep Quality	Pittsburgh Sleep Quality Index scale score	up to 7 months	No
Secondary	Stress	Perceived Stress Scale score	up to 7 months	No
Secondary	Emotional Support	Emotional Support subscale from the NIH Toolbox measures for social engagement	up to 7 months	No
Secondary	Friendship	Friendship subscale from the NIH Toolbox measures for social engagement	up to 7 months	No
Secondary	Hostility	Hostility subscale from the NIH Toolbox measures for social engagement	up to 7 months	No
Secondary	Loneliness	Loneliness subscale from the NIH Toolbox measures for social engagement	up to 7 months	No
Secondary	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	No
Secondary	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	No
Secondary	Nutrition	Diet History Questionnaire	up to 7 months	No
Secondary	Readiness for Change	Revised University of Rhode Island Change Assessment (R-URICA) readiness for change scale	up to 7 months	No
Secondary	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	No