Using Mobile Technology to Better Understand and Measure Self-Regulation

Health risk behavior, including poor diet, physical inactivity, tobacco and other substance
use, causes as much as 40% of the illness, suffering, and early death related to chronic
diseases. Non-adherence to medical regimens is an important exemplar of the challenges in
changing health behavior and its associated impact on health outcomes. Although an array of
interventions has been shown to be effective in promoting initiation and maintenance of
health behavior change, the mechanisms by which they actually work are infrequently
systematically examined. One promising domain of mechanisms to be examined across many
populations and types of health behavior is of self-regulation. Self-regulation involves
identifying one's goals, and maintaining goal-directed behavior. A large scientific
literature has identified the role of self-regulation as a potential causal mechanism in
promoting health behavior.

Advances in digital technologies have created unprecedented opportunities to assess and
modify self-regulation and health behavior. In this project, we plan to use a systematic,
empirical process to integrate concepts across the divergent self-regulation literatures to
identify putative mechanisms of behavior change to develop an overarching "ontology" of
self-regulatory processes.

This multi-year, multi-institution project aims to identify an array of putative
psychological and behavioral targets within the self-regulation domain implicated in medical
regimen adherence and health behavior. This is in service of developing an "ontology" of
self- regulation that will provide structure and integrate concepts across diverse
literatures. We aim to examine the relationship between various constructs within the
self-regulation domain, the relationship among measures and constructs across multiple levels
of analysis, and the extent to which these patterns transcend population and context. The
project consists of four primary aims:

Aim 1. Identify an array of putative targets within the self-regulation domain implicated in
medical regimen adherence and health behavior across these 3 levels of analysis. We will
build on Multiple PI Russ Poldrack's pioneering "Cognitive Atlas" ontology to integrate
concepts across divergent literatures to develop an "ontology" of self-regulatory processes.
Our expert team will catalog tasks in the self-regulation literature, implement tasks via
online testing (Mechanical Turk) to rapidly obtain large datasets of self-regulatory
function, assess the initial ontology via confirmatory factor analysis and structural
equation modeling, and assess and revise the resulting ontology according to neural
similarity patterns across tasks (to identify tasks for Aim 2).

Aim 2. Evaluate the extent to which we can engage and manipulate putative targets within the
self-regulation domain both within and outside of laboratory settings. Fifty smokers and 50
overweight/obese persons with binge eating disorder will participate in a lab study (led by
Poldrack) to complete the tasks identified under Aim 1. We will experimentally modulate
engagement of targets (e.g., stimulus set of highly palatable foods images or tobacco-related
images as well as self-regulation interventions). A comparable sampling of 100 persons will
participate in a non-lab study (led by Multiple PI Lisa Marsch) in which we will leverage our
novel mobile-based behavioral assessment/intervention platform to modulate target engagement
and collect data in real-world conditions.

Aim 3. Identify or develop measures and methods to permit verification of target engagement
within the self-regulation domain. Led by Co-I Dave MacKinnon, we will examine cross-assay
validity and cross-context and cross-sample reliability of assays. We will employ
discriminant and divergent validation methods and Bayesian modeling to refine an
empirically-based ontology of self-regulatory targets (to be used in Aim 4).

Aim 4. We will evaluate the degree to which engaging targets produces a desired change in
medical regimen adherence (across 4 week interventions) and health behavior among smokers
(n=100) and overweight/obese persons with binge eating disorder (n=100) (objectively measured
smoking in the former sample and binge eating in the latter sample). We will employ our novel
mobile behavioral assessment/intervention platform to engage targets in these samples, given
that (1) it offers self-regulation assessment and behavior change tools via an integrated
platform to a wide array of populations, and (2) content within the platform can be quickly
modified as needed to better impact targets. The proposed project is designed to identify
valid and replicable assays of mechanisms of self-regulation across populations to inform an
ontology of self-regulation that can ultimately inform development of health behavior
interventions of maximal efficacy and potency.

This protocol details the Aim 2 non-lab study led by Multiple PI Marsch.

This phase of the study takes what we learned about self-regulation in the first phase and
tests it in two samples that are exemplary for "lapses" in self-regulation: individuals who
smoke and overweight/obese individuals with binge eating disorder. We expect that many
real-world conditions (e.g., temptation, negative affect) may decrease self-regulation,
whereas training through the mobile intervention described below may increase
self-regulation. The primary purpose of this study is to determine whether we can shift
self-regulation for the ultimate goal (in Aim 4) of targeting self-regulation to impact
health behaviors.

Inclusion criteria:

- Age 21-50 years

- Understand English sufficiently to provide informed consent

- Use a smartphone (participants without mobile sensing); proficient with using
smartphone and comfort wearing devices (participants with mobile sensing)

- Additional inclusion criteria for binge eating sample:

- 27 ≤ BMI ≤ 45 kg/m2

- Have binge eating disorder according to the Diagnostic and Statistical Manual of
Mental Disorders, 5th Edition (DSM-5) criteria

- Non-smoking (defined as no cigarettes in past 12 months—this includes former and
never smokers)

- Additional inclusion criteria for smoking sample:

- Smoke 5 or more tobacco cigarettes/day for past year

- 17 ≤ BMI < 27 kg/m2

Exclusion criteria:

- Any current substance use disorder

o Will not exclude based on use of substances

- Currently pregnant or plans to become pregnant in next 3 months

- Lifetime history of major psychotic disorders (including schizophrenia and bipolar
disorder)

- Current use of any medication for psychiatric reasons (including stimulants and mood
stabilizers)

- Current use of prescription pain medications (e.g., Vicodin, oxycodone)

- Current use of any medication for smoking

- Exceptions: short-acting nicotine replacement therapy (e.g., gum, lozenge, nasal
spray, inhaler)

- Will screen out for Wellbutrin or varenicline

- Current use of any medication for weight loss

- Have undergone weight-loss surgery (e.g., gastric bypass, lap band)

- Current nighttime shift work or obstructive sleep apnea

- Note: We will not exclude based on e-cigarette use.

- Additional exclusion criteria for binge eating sample:

- Compensatory behavior (e.g., purging, excessive exercise, fasting) [already
excluded as part of the DSM-5 binge eating disorder criteria]

- Lost weight in recent past (>10 pounds in past 6 months)

- Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig) [will not
exclude on online/mobile app weight-loss programs]

- Currently on a special diet for a serious health condition

- Additional exclusion criteria for smoking sample:

- Binge eating behavior according to Questionnaire on Eating and Weight Patterns-5
(QEWP-5) ("yes" to Qs 8 and 9 and for Q10, at least one episode per week for
three months).

- - QEWP-5 #8: During the past three months, did you ever eat in a short period of
time (for example, a two-hour period) what most people would think was an
unusually large amount of food? [yes or no]

- - QEWP-5 #9: During the times when you ate an unusually large amount of food, did
you ever feel you could not stop eating or control what or how much you were
eating? [yes or no]

- - QEWP-5 #10: During the past three months, how often, on average, did you have
episodes like this? That is, eating large amounts of food plus the feeling that
your eating was out of control? (There may have been some weeks when this did not
happen. Just average those in.) [less than one episode per week, five response
options for 1 or more episodes per week]