Movement-Oriented Behavioral Activation (MOBA) to Reduce Stationary Behavior
Phase: NA
Conditions: Sedentary Behavior
Sponsor: Duke University

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Aim 1: Determine feasibility and acceptability of a 10-week group MOBA intervention for individuals with 
excessive stationary behavior compared to waitlist control.
Aim 2: Assess activity and mobility changes following a 10-week group MOBA intervention for individuals 
with excessive stationary behavior compared to waitlist control.
      
 Individuals completing MOBA will have greater (1) improvement in physical performance, 
Hypothesis:
(2) reduction in sedentary time, and (3) increase in daily step count after 12 weeks compared to the
control group.
Aim 3: Examine changes in activation, avoidance, and perceived barriers to physical activity after a 12-
week group MOBA intervention for individuals with excessive stationary behavior compared to waitlist
control.
      
 Individuals completing MOBA will have greater (1) increase in activation, (2) decrease in 
Hypothesis:
avoidance, and (3) decrease in self-reported barriers to physical activity after 12 weeks compared to the 
control group.
Background & Significance
Should support the scientific aims of the research
Stationary behavior, defined as excessive sitting and/or standing without ambulation, is associated with 
multiple morbidities acquired by adults through the lifespan that lead to loss of mobility and diminished 
functional independence in older adulthood. The prolonged lack of movement that characterizes stationary 
behavior is associated with health risks independent of the health benefits of exercise. The attributes and 
antecedents of stationary behavior are distinct from exercise as well. This highlights a 
 for 
critical need
interventions that are specific to encouraging the regular movement-oriented behaviors needed to reduce 
the risks of prolonged stationary time, and which account for the key settings where these behaviors 
occur. Identifying and engaging the behavioral mechanisms that uniquely drive stationary behavior across 
.
settings will be essential to achieving lasting behavioral change
Prevailing approaches to changing stationary activity have two weakness: they are overeliant on external 
motivators to produce behavior change, and they devote insufficient attention to the range of settings in 
which the behaviors occur. The current study is 
, which 
grounded in reinforcement sensitivity theory (RST)
was developed to explain internal motivational processes in responding to environmental stimuli. RST 
encompasses two primary motivational systems: the behavioral inhibition system (BIS) and the behavioral 
activation system (BAS). The BIS guides behavior in response to aversively conditioned stimuli, whereas 
the BAS guides behavior in response to rewarding stimuli. From the perspective of RST, excessive 
stationary behavior reflects a learned avoidance of movement resulting from aversive barriers to activity 
. The rationale of the proposed study is 
and lack of contact with rewards that activate alternative responses
that an intervention based on 
 (BA), which was originally developed to treat 
behavioral activation therapy
depression, can reduce the avoidance that perpetuates stationary behavior by systematically engaging 
individuals in personally valued and rewarding non-stationary alternatives.
The 
 of the proposed study, “
significance
Movement-Oriented Behavioral Activation (MOBA) to Reduce 
,” is that it addresses an important public health need for a cross-cutting intervention 
Stationary Behavior
to reduce stationary behavior. It is significant that the intervention occurs in the setting of an occupational 
health program, which provides close contact to work-related risk factors like stationary behavior. The 
significance of the occupational health approach is also related to the pilot cohort, which will be 
predominantly African American. Unequal access to preventative health services among minorities is a 
problem in this country, and workplace interventions can be an important strategy in addressing this 
disparity. Our choice to target stationary behavior rather than the conventional sedentary behavior 
(excessive sitting) is significant as well. Emerging evidence indicates that prolonged passive standing is as 
common in workplaces as excessive sitting and has comparable risks to health and mobility; thus, 
interventions targeting change in the 
-- lack of ambulatory movement-- will be more 
common risk behavior
potent and translatable than those targeting either behavior alone. The significance of the proposed 
research is enhanced by 
 1) MOBA is a novel approach to changing stationary 
innovative elements:
behavior, particularly the intrinsic, person-centered principles of behavior change that are 
underemphasized in existing interventions; and 2) the intervention is innovative in its inclusion of an 
ecological framework, the Behavior Settings Model, which allows closer contact between personally valued 
activities and the multiple settings in which stationary behaviors occur. 
Design & Procedures
Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 

placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Overview. 
The study uses randomized waitlist-control design. We propose to randomly assign half of participants to 
(a) 10 weeks of MOBA intervention, and half of participants to (b) a 10-week waitlist, followed by 10
weeks of MOBA.
Intervention. MOBA is adapted from established protocols to integrate traditional behavioral activation 
(BA) principles with strategies to incorporate values-based, goal-directed movement into daily routines. 
The BA content of MOBA is adapted from co-investigator Dr. Smoski’s intervention Behavioral Activation 
Therapy for Anhedonia (BATA). MOBA reduces depression-related content relative to BATA and increases 
focus on values that engage individuals in movement-related activity. MOBA is designed as a group 
intervention to leverage the reward value of social contact, and the positive influence of group problem-
solving and accountability on behavior change. MOBA preserves the principles and general sequence of 
sessions used in BATA, but incorporates movement-oriented content: (a) provide psychoeducation about 
risks of physical inactivity, behavioral barriers to activity, and rationale for the treatment approach; (b) 
explore personal values, non-stationary, movement-oriented activities that support those values, and a 
hierarchical plan for goal attainment; (c) identify and assign weekly activities related to the valued goals; 
(d) address common barriers to engagement with valued activities including avoidance, low behavioral
initiation, and an overemphasis on felt motivation as a prerequisite for action; and (e) monitor, support,
and reward achieving behavioral goals. Content unique to MOBA includes: 1) demonstration and
participation in physical activities that provide alternatives to stationary behavior, including select activities
used in a previous study with the Dining Services cohort (e.g., stairs, body-weight squats, knee raises),
and 2) generation of person-centered strategies for integrating movement-oriented activities into daily
routines across the three domains of the Behavior Settings Model: 1) workplace sitting/prolonged
standing, 2) screen-focused home activities, 3) time spent sitting in automobiles. Weeks 1-4 address
topics a-c; weeks 5-12 address topics d-e. MOBA will be facilitated by a clinician (Dr. Potter) and a
wellness educator (Dr. Tittle), who will be trained on the MOBA treatment manual. The facilitators’ role is
to provide teaching, support, encouragement, and guidance throughout the intervention. Weekly sessions
will take place in a dedicated conference room near the workplace, during the last hour of the workday (4-
5 pm), and is counted as paid time at work.
Assessments. 
        Pre-intervention focus group. Separately, and prior to the enrollment in the intervention, 
we plan to conduct a small focus group of individuals (N = 8-10) from the Duke Dining Service 
staff in order to (1) better understand perspectives and experience with physical activity; (2) 
gauge interest in aspects of the study, and (3) understand format preferences for presenting 
and collecting information. The goal is to gather information to improve delivery of the 
intervention to participant stakeholders.  Individuals who participate in the focus group are not 
under any obligation to participate in the intervention.
We plan to collect multiple sources of information to provide 
Feasibility and acceptability. 
information about feasibility and acceptability: 
(1) We will document our challenges and decisions across all aspects of the study (e.g., recruitment,
engagement, obstacles to enrollment) to optimize the translation of our findings; (2) We will collect
descriptive data on adherence and participant engagement; (3) We will collect and characterize descriptive
information on experience, perceived benefits, and satisfaction; (4) We will conduct focus groups with
participants, and those who declined to participate, to better understand “what worked” and “what needs
work” with respect to the intervention. We will consult with Duke Roybal Center intervention experts for
input on our approach. Fidelity to the treatment will be assessed by Dr. Smoski, who does not lead groups,
but will review taped sessions to document adherence (e.g., whether content described in treatment
manual is presented during sessions).
        
 Short Physical Performance Battery (SPPB) will assess lower extremity function and 
Mobility testing.
mobility.
 The 6-Minute Walk Test (6MWT) will assess functional exercise capacity. These measures will 
11
occur at Baseline and Week 10. 
         
The Behavioral Activation in Depression Scale (BADS) will assess state 
Mechanisms of change. 
characteristics of avoidance and activation. This measure will be administered at baseline and week 5. The 
Barriers to Being Active Quiz will assess perceived barriers to regular movement-oriented activity. These 
measures will be administered at baseline and post-intervention.
        
With no validated questionnaire specific to stationary behavior, self-reported 
Stationary behavior. 
sedentary activity will be assessed at baseline/post-assessment, and weekly during the intervention using 
the Past-Day Adults’ Sedentary Time questionnaire (PAST). The PAST assesses multiple domains of 
sedentary behavior over the past day; it was found to have the highest correlation to device-based activity 
compared to other questionnaires. The PAST will be administered at baseline, weekly, midpoint, and post 

assessment. Device-based tracking. Participants will wear an Actigraph Actilife 6 accelerometer on the 
right hip for 7 days prior to MOBA participation. This period will represent the pre-intervention control 
activity condition for each participant. Participants will similarly wear the Actigraph for 1 week post-
intervention. The main outcomes of device-based tracking will be percent change in step count per day, 
with secondary measures including total activity count, and physical activity energy expenditure.
MOBA intervention sessions will occur weekly. 
The following questionnaires will also be administered. PHQ-9 will be collected at baseline and week 10, 
which is post assessment. Physical Activity Readiness will be collected at baseline. The Brief Health 
Questionnaire will be collected at baseline an week 10. At the final session, a MOBA Class Feedback form 
will be completed by the participants.  
As shown in Table 1, participants will complete a baseline assessment administered by a fitness specialist 
that incudes questionnaires and mobility testing. These assessments will be repeated at end of the 
intervention. Additionally, the wait-list control group will complete a third assessment at the end of their 
02-week participation in MOBA.
April 6, 2022 An amendment to remove the participant initials from the last page of the consent is 
incorporated to prevent consent deviations.  
May 16, 2022 An amendment to request permission for a magazine article e.g., Work at Duke, to be 
written about the MOBA project. This article will include pictures of participants and interviews, if they 
agreed. These pictures would require a release to other purposes, such as presentations or an eventual 
website. It is hoped that the article could be written with the next set of assessments, which is scheduled 
near the end of June. By participating in the article, participant's involvement would no longer be 
confidential. 
Selection of Subjects
List inclusion/exclusion criteria and how subjects will be identified.
Participants. 
 The pilot cohort will be composed of members of the Duke Dining Service 
Inclusion:
staff age 30-64. The age range was chosen to target the critical window for establishing the long-term 
. The age range has also been 
geroprotective benefits of increasing movement-oriented behaviors
expanded to allow for participation by all members of the Dining Service. The workplace cohort was chosen 
because their work demands are characterized by a high level of stationary activity, and because of 
previous success recruiting this group to participate in the Healthy Duke 
 (MTC) 
Making the Connection
wellness initiative. Additionally, 58% of this cohort reported >5 hours sitting per day, which indicates high 
levels of sedentary behavior in addition to stationary behavior at work. In MTC, the participating cohort 
was 72% female, and 80% were between age 30-64. 
: 1) individuals with moderate or greater 
Exclusion
depression severity (PHQ-9 > 14); and 2) individuals with significant mobility limitation, defined as 
inability to complete 6 Minute-Walk Test. We plan to include rather than exclude individuals with medical 
comorbidities (e.g., diabetes, cardiac conditions, obesity) because this provides the most representative 
sample of the stationary population, and is consistent with our goal of developing a cross-cutting and 
translatable intervention. The Dining Services workforce is >90% African American, which is a group with 
disproportionately lower physical activity; and 3) individuals who answer "Yes" to any of the questions on 
the Physical Activity Readiness Questionnaire (PAR-Q) will be encouraged to consult with their physician 
before proceeding with the study. Physician clearance is not required for participation. 
. We 
Sample size
plan to recruit 16 individuals for each of the two MOBA groups (N = 32), which allows for 23% attrition 
based on prior MTC completion rates.
Subject Recruitment and Compensation

Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
The opportunity to participate will be presented to employees by the supervisor of East Campus Dining. 
The opportunity will be clearly presented as voluntary and having no bearing in employment or 
performance evaluations. We will work with the supervisor to facilitated recruitment through assistant 
managers, emails, flyers, and staff meetings. 
The age diversity of the sample is guided by the research question, which is oriented toward mid-to-late 
middle age, and aligns with the target population of the Roybal Center, which is funding entity for this pilot 
study.  The demographics are guided by the workforce cohort chosen for the pilot study, which is based 
workplace demands and past participation in successful workplace activity initiatives. However, the target 
population in predominantly African American, which is a demographic group that is often 
underrepresented in intervention research on physical activity.
The target cohort for this pilot study will be composed of Duke University employees, but not DUHS 
employees.
Participant Remuneration 
Baseline assessment ($50), post-intervention assessment ($70), 2-month follow-up interview (32 x $20), 
non-participant interview (20 x $20).  
We plan assessment proximate to the workplace, so there will be no travel costs.  The intervention occurrs 
on paid time, and will not result in lost wages.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
This is not applicable.  All participants will have the capacity to give legally effective consent.
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.
The behavioral intervention is described above.  There is no use of an investigational drug, biologic, or 
device.
Risk/Benefit Assessment

Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant women, prisoners or cognitively impaired 
adults), what special precautions will be used to minimize risks to these subjects? Also identify what 
available alternatives the person has if he/she chooses not to participate in the study. Describe the 
possible benefits to the subject. What is the importance of the knowledge expected to result from the 
research?
Mobility and fitness testing has a low risk of complications, and the physical assessment in the study are 
widely used, including in populations with medical conditions and mobility limitations. All physical 
assessment are administer by a trained fitness specialist.
Brief low intensity activities will be taught during MOBA session, and have low risk of complications
/injury.  These are also taught be a trained fitness specialist. Participants will be choosing low-to-moderate 
physical activities in which they will voluntarily engage during their time out of work. Trained fitness 
specialists will provide guidance on a range or appropriate activities and progression of activity 
level.  These voluntary activities will be expected to have low risk of complications/injury.  
There may be risks, discomforts, or side effects that are not yet known.
Vulnerable populations will not be included in this study.
The possible benefits of participation in this study are expected to be improved mobility and decreased 
stationary behavior, which reduced multiple health and injury risks.  The knowledge from the research is 
expected to result in a better understanding of how to motivated individuals to decrease stationary 
behavior and increase physical activity. 
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
We do not anticipate any costs incurred by participants as a result of participation.
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
Sample size was based on previous recommendations from Lancaster et al. that targeting approximately 
30 participants is a pragmatic standard for feasibility trials. While we recognize this sample size will not 
allow us to derive meaningful effect size estimates for between-group comparisons in this pilot study, it 
will be useful in determining the acceptability of the proposed intervention and deriving variance metrics (e.
g., standard deviation of physical activity outcomes) for the purposes of future effect size estimation. We 
acknowlege that the proposed sample size is not adequate for formally testing group differences or effect 
size metrics. We will therefore (a) interpret these comparisons as preliminary, (b) characterize effect sizes 
for pre-to-post changes within each group separately, and (c) characterize group changes in actigraphy 
using contemporary minimum clinically important difference (MCID) metrics (e.g., 500 steps / day).
Analysis plan for Aim 1. We plan to collect multiple sources of information to provide information about 
feasibility and acceptability: (1) We will document our challenges and decisions across all aspects of the 
study (e.g., recruitment, engagement, obstacles to enrollment) to optimize the translation of our findings; 
(2) We will collect descriptive data on adherence and participant engagement; (3) We will collect and
characterize descriptive information on experience, perceived benefits, and satisfaction; (4) We will
conduct focus groups with participants, and those who declined to participate, to better understand “what
worked” and “what needs work” with respect to the intervention. We will consult with Duke Roybal Center
intervention experts for input on our approach. 
: We will use data from the PAST
Areas of efficacy
questionnaire to identify which domains of activity are most and least responsive to MOBA. Fidelity to the

 will be assessed by Dr. Smoski, who does not lead groups, but will review taped sessions to 
treatment
document adherence (e.g., whether content described in treatment manual is presented during sessions).
Analysis plan for Aim 2. To test 
, we will examine mean difference in SPPB and 6MWT 
Hypothesis 2
between baseline and post-intervention performance (e.g., student’s -test). We will also examine percent 
t
change and effect size (e.g., Cohen’s ). To test 
, we will compare change in self-reported 
d
Hypothesis 2b
sedentary time between baseline and post-intervention. We will plot and visually examine trends of change 
across monthly questionnaires. Additionally, we will examine change in Actigraph measures between 
baseline and post-intervention. As part of this aim, we will examine the association between self-report 
(PAST) and device-measured activity.
Analysis plan for Aim 3. To test 
, we will examine mean difference, percent change, and 
Hypothesis 3
effect size in BADS (Avoidance and Activation scales) and BBAQ total score between baseline and post-
intervention assessments.
Reference Cited:
Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good 
practice. 
2004;10(2):307-312.
J Eval Clin Pract. 
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
The study team includes three licensed clinical psychologists who will review any potential safety concerns 
at regular meetings, at least montly. Other staff will be asked report any potential safety concerns to the 
PI. 
Adverse events will be systematically monitored at the time of enrollment, initiation of the study 
intervention, at the conclusion of the 6-month program. Although we anticipate few adverse events, we 
note that any intervention-related adverse events will be reviewed by the clinical team on a regular basis. 
For the purposes of the proposed study, an adverse event is defined as any undesired, noxious, or 
pathological change in a participant, as indicated by symptoms that occur in association with study 
participation.  Pre-existing conditions that worsen during a study are considered adverse events. Serious 
Adverse Events (SAE) are defined as any adverse event that results in any of the following outcomes:
Death or a life-threatening illness including active suicidal ideation/attempt (such as drug overdose)
A persistent or significant disability/incapacity
A requirement for hospitalization ≥24 hours
Participants will be screened with the PHQ-9 at enrollment, and those individuals with moderate or greater 
depression severity (PHQ-9 > 14) will be excluded; however, they will also be contacted for a wellness 
interview by the PI, and provided resources for care, such as Duke Personal Assistance Service.
All staff involved in the design or conduct of the study will receive and maintain the required education on 
the protection of human research participants prior to funding of the project. Dr. Potter, Dr. Smoski, and 
Dr. Smith are all licensed clinical psychologists and will be available 24/7 for emergent and/or urgent 
study-related issues. Primary on call availability will be with Dr. Potter, and Dr. Smoski and Dr. Smith will 
provide back up as needed.