The Pick Two to Stick To Habit Development Intervention
Phase: NA
Conditions: Metabolic Syndrome
Sponsor: Wayne State University

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The Pick Two to Stick To Habit Development Intervention 
NCT03370419 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Specific Aims  
Together, diabetes and cardiovascular disease cost the U.S. economy a staggering $557.6 billion 
annually and are the leading chronic diseases of Black Americans. Maintaining a healthy body weight 
by being physically active and eating a healthy diet are the best means of reducing cardio-metabolic 
risk factors. Despite decades of behavioral research, however, lifestyle interventions targeting activity 
and diet have made little progress in effecting widespread and enduring health behavior changes in 
the populations most at risk for developing these conditions. We argue that addressing the role of 
habits, defined as behavior patterns operating below conscious awareness that are acquired through 
context-dependent repetition, would significantly improve the effectiveness of lifestyle interventions. 
Most simply, habits develop when repetition of a behavior (e.g., walking for 10 minutes) occurs in 
connection with a stable situational cue that supports the behavior (e.g., while on a lunch break). 
Once established, habits are cued by the characteristics of a specified recurring situation rather than 
by intentions. Recent research suggests that habit development may prevent relapse and aid 
maintenance of behavior changes beyond the duration of the intervention because the performance 
of habitual behaviors is less vulnerable to changes in motivation, mood, or extraneous circumstances. 
Emerging evidence also suggests that habit-development strategies are effective across a range of 
behaviors (e.g., dental flossing, physical activity, and dietary behaviors) and a range of settings to 
target the development of healthful physical activity and dietary habits. Nonetheless, these concepts 
and methods have yet to be fully tested to determine their feasibility as a treatment modality for 
promoting healthful lifestyle behavior changes.  
The short-term objective of the proposed research is to test the feasibility of of 80 Black American 
adults ages 40 and older with metabolic syndrome (MetS). We hypothesize that a habit- focused 
approach will be feasible to implement and acceptable to intervention recipients. We will pursue the 
following specific aims.  
1. To evaluate intervention feasibility and acceptability. Determine if the intervention used in the 
proposed project is feasible. By tracking time, effort, costs, adherence to recommendations, 
participant recruitment and retention rates, and intervention satisfaction, we expect to be able to 
provide data that both support the feasibility of the intervention and help us improve it for a 
subsequent study.  
2. To estimate intervention effect sizes for the primary outcome measures of habit 
development. Habit development and anthropometry will be measured using the four-item Self-
Reported Behavioral Automaticity Index (Gardner et al., 2012) at baseline and Week 20.  
 
Significance  
Because individuals with MetS are twice as likely to develop heart disease and five times as 
likely to develop diabetes than those without MetS (NHLBI, 2011), the condition poses a serious 
threat to the already strained U.S. healthcare system. Its impact on minority communities, especially 
Black Americans, is even more significant. Intensive lifestyle interventions have that modest weight 
loss achieved through modifying dietary and physical activity behaviors positively impacts the five 
components of MetS and can significantly reduce or delay the onset of cardiovascular disease (CVD) 
and diabetes in high-risk individuals (Yamoko & Tango, 2012; UKPDS Group, 1996). However, the 
time and resource demands needed to derive such benefits limits the feasibility of this approach in 
resource-restricted settings and its appeal to individuals unable or unwilling to commit to such 
intensive intervention (Dale Grave et al., 2005). Results of efforts to scale down interventions to be 
amenable to real-world settings while still producing sustainable improvements in health outcomes 
have been mixed (Dunkley et al., 2012). Thus, there remains an urgent need to develop efficacious 
lifestyle behavior change programs that are both scalable to real-world conditions and accessible and 

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acceptable to a range of populations at risk of MetS and CVD.  
A promising and novel approach to fostering health-promoting lifestyle changes is targeting the 
development of physical activity and dietary habits as part of behavioral interventions. While theory 
and empirical evidence supports the role of two pathways in behavior change—an intentional 
pathway based on deliberative thought and action and an automatic (habitual) route enacted in 
response to contextual cues (Evans, 2008)—interventions to date have focused on intentional 
processes and neglected habit development. Recently conducted habit-focused behavioral trials, 
however, demonstrate that habit-development strategies are positively correlated with key health 
outcomes (e.g., weight loss and maintenance and healthy dietary intake) (Carels et al., 2014; 
McGowan et al., 2013). The proposed habit-focused intervention promises similar results for 
participants with MetS and to enhance occupational therapy’s contribution to solving pressing societal 
needs vis-à-vis developing a broader range of interventions for use in other populations with chronic 
health conditions and underserved populations.  
We propose to implement a habit-based approach in a high-risk subgroup recruited from the 
emergency department (ED) of a safety-net institution located in Detroit, MI (whose 2014 population 
was 82% African- American). By focusing on the effect of habit development in physical activity and 
dietary behavior and its relevance to key health outcomes in an at-risk population, this project will set 
the stage for a broader study of a habit-based approach with more diverse patient groups and 
disease states. Should the habit-development approach be feasible and prove to be successful 
across a range of circumstances, our research’s long-term impact on cardio-metabolic risk and 
related health outcomes would be immense.  
C. Approach  
 
Trial Setting:  
Enrollment for this study will occur in the emergency department (ED) of Detroit Receiving 
Hospital (DRH) in Detroit, MI, which is part of the eight-hospital Detroit Medical Center (DMC). In 
Detroit, where 59% of the population lives in a medically underserved area and in poverty (Detroit 
Health Care Stabilization Workgroup, 2007), reliance on the ED for primary care is commonplace and 
access to lifestyle behavior change programming is limited. Once enrolled, study participants will 
complete data collection visits in the Wayne State University (WSU) Clinical Research Service Center 
(CRSC), also located in Detroit, approximately two miles from the DRH ED in the newly built WSU 
Integrated Biomedical Research building. Both sites are under the directorship of Dr. Phillip Levy, a 
co-investigator on this proposal, ensuring a seamless transition.  
Sampling and Recruitment: Recruitment will occur on-site in the DRH ED through active 
screening by Dr. Levy’s team 24 hours a day, 365 days a year using the same highly successful 
approach employed in his other ED-based studies. Dr. Levy has a highly trained research staff, 
including more than 50 paid and voluntary screeners who work on multiple studies at the same time 
(> 20 at the time of this grant submission). His team has extensive experience recruiting in this 
setting. After reviewing basic study information, patients who are interested in participating will be 
provided with an in-depth review of the study consent form and a signed informed consent form will 
be obtained.  
We will recruit a sample of 80 subjects with MetS aged 40 and above, targeting equal numbers 
of men and women. We will use a modified MetS screening criteria that will allow us to identify 
potential participants at the point of care in the ED. The criteria include two or more of the following 
three cardio-metabolic risk factors: waistline > 40 inches for men and > 35 inches for women; blood 
pressure > 130/85; and HbA1c of 5.7%-6.4%. Adults who present to the ED with non-life threatening 
conditions and who agree to receive text messages on their cell phones will be eligible for inclusion. 
Participants must have at least two of the three risk factors confirmed via documentation in their 
medical record. For this pilot study, we will restrict enrollment to English-speaking subjects who will 

be discharged to home from the ED. Pregnant patients and those with any history of the following will 
also be excluded: previous diagnosis of resistant HTN; steroid-dependent asthma or emphysema; 
cirrhosis or hepatic failure; a cardiac event within the last 30 days; chronic kidney disease on renal 
replacement therapy; cancer (terminal or undergoing active chemotherapeutic or radiation therapy); 
taking medications for weight reduction or already being involved in a weight reduction program. 
Patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to 
complete study activities also will be excluded.  
Trial Procedures:  
Once enrolled (Week -2), participants will be scheduled for a return visit in two weeks at the 
CRSC (Week 0), where baseline data collection will occur and participants will be randomized into 
one of the two study arms. Based on Dr. Levy’s ongoing NIH-funded study of uncontrolled HTN 
(5R01MD005849-05), we anticipate attrition to be greatest between ED recruitment and the first  
follow-up visit (25.3%). Thus, delaying randomization until after this 2-week run-in period will reduce 
the likelihood of loss to follow-up. In Week 0, participants complete baseline measures and are 
randomized in equal numbers to one of two arms: Arm 1: Usual Care or Arm 2: Habit-focused 
Intervention. Usual care participants will receive freely available informational brochures containing 
information about making healthful dietary and physical activity changes but will receive no further 
intervention. Usual Care participants will be asked to return to the CSRC in Week 20 for the follow-up 
data collection visit.  
C.5.1. Habit-Focused Arm. The intervention will be delivered by Dr. Fritz (PI), a licensed 
occupational therapist and certified health coach trained in Motivational Interviewing. The habit-
focused arm utilizes a “low and slow” approach to behavior change whereby simple changes in habits 
are hypothesized to accumulate over time to impact health outcomes. Participants will be asked to 
commit to developing two new low-complexity habits (one dietary management habit and one 
physical activity habit) every 2 weeks over the 8-week intervention period (8 habits total). The 
intervention approach is based upon the following assumptions: (a) simple behaviors are more likely 
to become habits than more complex behaviors (Lally, Jaarsveld, Potts, & Wardle, 2010); (b) less-
intensive approaches to lifestyle behavior changes may be easier to maintain long term (Hagobian & 
Phelan, 2013); and (c) significant changes in habit development can be seen in as little as 2 weeks 
(McGowan et al., 2013). Introducing two new health habits every 2 weeks is hypothesized to allow the 
previously selected habits to sufficiently develop before additional habits are pursued.  
The intervention components (see Table 2) are designed to target the relationships among intentions, 
performance patterns, and performance contexts that affect habit development. Intervention 
participants will be asked to participate in five health-coaching sessions and to return to the CRSC in 
Week 20 for follow-up data collection. The initial face-to-face coaching session is expected to last 
approximately 60 minutes with subsequent telephone sessions lasting approximately 30 minutes.  
Coaching sessions will be augmented with the use of the Habit Recorder workbook (Appendix A), an 
informational workbook that contains information about MetS, healthy lifestyle behaviors, and the 
principles of habit development along with worksheets to guide the construction of context 
modifications and implementation intentions. Each session, participants select two new habits to 
develop and carry forward. Targeting two new habits every 2 weeks is hypothesized to reduce the 
burden of developing multiple new habits during the intervention period.  
Participants will be asked to record their intentions and modifications in the Recorder, and 
those data will be used to individually tailor study text messages. For example, for the intention “I will 
walk for 10 minutes every evening before dinner,” the message would include the specific intention 
and be delivered at a participant- identified time that coincides with the intended behavioral 
performance. We will use Movisens XS, a customizable ambulatory momentary assessment platform 
that allows the research team to administer assessments and deliver tailored text notifications.  
Trial Participant Retention. We will use previously successful retention strategies to encourage 
participation for the full trial, including routinely obtaining contact information for the participants and 
up to three friends/relatives who could help locate them. We anticipate that the regularly scheduled 
coaching sessions will help foster participant retention in the intervention arm. To reduce the 

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likelihood of participant attrition in the control arm, we will contact participants at Week 8 of the study 
to express our appreciation for their involvement in the study, update contact information if needed, 
and to remind the participant of the Week 20 follow-up data collection visit. All participants will also 
receive the study coordinator’s cell phone number. We will also incentivize data collection by 
providing $25 for completing each component of the study (total incentive of up to $150/participant).  
 
Trial Measures and Data Collection.  
Acceptability of the Intervention: After receipt of the intervention, participants will be asked to 
participate in a structured interview to better understand the users’ experience of the intervention and 
to elicit suggestions for intervention improvements. We will target intervention completers, non- 
completers, and refusers to develop a more holistic understanding of participants’ intervention 
experiences and reasons for non-participation. Individuals will receive $25 for their participation in the 
interview.  
Process Assessment: Following the example of Tickle-Dengnen (2013), we will track multiple 
indicators of trial feasibility, including the following:  
We will also assess the primary outcome of Habit Development: Habit development will be 
measured using the four-item Self-Reported Behavioral Automaticity Index (SRBAI) (Gardner et al., 
2012) at baseline and Week 20. The SRBAI contains stem statements that can be adapted to 
address desired behavioral domains (e.g., physical activity, dietary behaviors). Every participant will 
complete the global SRBAI created for the study (Appendix C). Intervention participants will also 
complete the SRBAI questions that are tailored to the specific habits that they selected to develop 
(Appendix D).  
Covariates will be measured at baseline (Week 0) and include the seven-item Rapid Estimate 
of Adult Literacy in Medicine: Short Form (REALM-SF) (Nevarez, Alvarez, Tzuang, & Gallagher-
Thompson, 2011) and a socio-demographic factors using a socio-demographic survey.  
Data Analysis:  
Descriptive statistics (proportions, rates) will be used to assess quantitative process 
component measures (Aim 1, section D.5.3.b) and to determine M, SD, and effect sizes (Cohen’s d) 
for outcome variables to inform power analyses for the subsequent study (Aim 2). We will analyze the 
interview data using qualitative thematic analysis (Boyatzis, 1998). To maintain rigor, we will also 
work to minimize threats to validity using a five-step qualitative analysis training model (Luborsky, 
2001). A systematic approach to data coding is expected to enhance coding reliability and overall 
quality of study results.