Clinical trial NCT02290912: Gray Matters Alzheimer's Disease Prevention Intervention
Official title: Gray Matters: Multi-domain Lifestyle Behavioral Alzheimer's Disease Prevention Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease prevention lifestyle intervention
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 146
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Picture Vocabulary
timeFrame: up to 7 months
measure: Flanker Inhibitory Control and Attention Test
timeFrame: up to 7 months
measure: List Sorting Working Memory Test
timeFrame: up to 7 months
measure: Oral Symbol Digit Test
timeFrame: up to 7 months
measure: Montreal Cognitive Assessment
timeFrame: up to 7 months
measure: Rey Auditory Verbal Learning Test
timeFrame: up to 7 months
measure: Controlled Oral Word Association Test
timeFrame: up to 7 months
measure: Blood pressure
timeFrame: up to 7 months
measure: Body mass index
timeFrame: up to 7 months
measure: Insulin
timeFrame: up to 7 months
measure: Systemic inflammation
timeFrame: up to 7 months
measure: Skin carotenoid status
timeFrame: up to 7 months
measure: Triglycerides
timeFrame: up to 7 months
measure: HDL Cholesterol
timeFrame: up to 7 months
measure: LDL Cholesterol
timeFrame: up to 7 months
measure: Total cholesterol
timeFrame: up to 7 months
Secondary outcomes:
measure: Depression
timeFrame: up to 7 months
measure: Motivation
timeFrame: up to 7 months
measure: Sleep Quality
timeFrame: up to 7 months
measure: Stress
timeFrame: up to 7 months
measure: Emotional Support
timeFrame: up to 7 months
measure: Friendship
timeFrame: up to 7 months
measure: Hostility
timeFrame: up to 7 months
measure: Loneliness
timeFrame: up to 7 months
measure: Physical Activity - Moderate
timeFrame: up to 7 months
measure: Physical Activity - Vigorous
timeFrame: up to 7 months
measure: Nutrition
timeFrame: up to 7 months
measure: Readiness for Change
timeFrame: up to 7 months
measure: Metacognition
timeFrame: up to 7 months
Other outcomes:
Locations:
Study officials:
affiliation: Utah State University
name: Maria C Norton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.