title: The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial.
abstract: BACKGROUND
  Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention.
  
  
  OBJECTIVE
  The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change.
  
  
  METHODS
  The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke "Gray Matters" mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user's performance, calculated from reported behaviors against recommended guidelines.
  
  
  RESULTS
  This paper explores the rationale for a mobile phone-led intervention and details the app's effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=-3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly better in attaining their recommended daily goals (mean 56.21 SD 30.4%) than those who increased their BMI (mean 40.12 SD 29.1%), t80 = -2.449, P=.017. In total, 69.2% (n=18) of those who achieved a mean performance percentage of 60% or higher, across all domains, reduced their BMI during the study, whereas 60.7% (n=34) who did not, increased their BMI. One-way analysis of variance of systolic blood pressure category changes showed a significant correlation between reported efforts to reduce stress and category change as a whole, P=.035. An exit survey highlighted that respondents (n=83) reported that the app motivated them to perform physical activity (85.4%) and make healthier food choices (87.5%).
  
  
  CONCLUSIONS
  In this study, the ubiquitous nature of the mobile phone excelled as a delivery platform for the intervention, enabling the dissemination of educational intervention material while simultaneously monitoring and encouraging positive behavior change, resulting in desirable clinical effects. Sustained effort to maintain the achieved behaviors is expected to mitigate future AD risk.
  
  
  BACKGROUND
  ClinicalTrails.gov NCT02290912; https://clinicaltrials.gov/ct2/show/NCT02290912 (Archived by WebCite at http://www.webcitation.org/6ictUEwnm).
authors.affiliation: Computer Science Research Institute, Ulster University, Newtownabbey, United Kingdom. pj.hartin@ulster.ac.uk.
authors.forename: Phillip J
authors.identifier: http://orcid.org/0000-0001-5671-8095
authors.initials: PJ
authors.lastname: Hartin
authors.forename: Chris D
authors.identifier: http://orcid.org/0000-0003-0882-7902
authors.initials: CD
authors.lastname: Nugent
authors.forename: Sally I
authors.identifier: http://orcid.org/0000-0002-6871-3504
authors.initials: SI
authors.lastname: McClean
authors.forename: Ian
authors.identifier: http://orcid.org/0000-0003-2368-7354
authors.initials: I
authors.lastname: Cleland
authors.forename: JoAnn T
authors.identifier: http://orcid.org/0000-0003-1766-2556
authors.initials: JT
authors.lastname: Tschanz
authors.forename: Christine J
authors.identifier: http://orcid.org/0000-0003-2693-8710
authors.initials: CJ
authors.lastname: Clark
authors.forename: Maria C
authors.identifier: http://orcid.org/0000-0001-9261-6977
authors.initials: MC
authors.lastname: Norton
keywords: Alzheimer disease; behavior; behavior change; health behavior; motivation; smartphone