Gray Matters Alzheimer's Disease Prevention Intervention

NCT02290912 | Completed

• 1 other identifier: 5606
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease prevention lifestyle intervention

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (13)

• Depression

  up to 7 months

• Motivation

  up to 7 months

• Sleep Quality

  up to 7 months

• Stress

  up to 7 months

• Emotional Support

  up to 7 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Health education program

Control

NO INTERVENTION

No intervention

Interventions

Health education program 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).

Treatment

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Utah State University: lead

Related Publications (1)

• 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.

  PMID: 27485822 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria C Norton, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 14, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2015

Record last verified: 2015-12