Designing With Dissemination in Mind: Development of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy; Aim 1, Phase 2
Phase: NA
Conditions: Overweight and Obesity, Physical Inactivity
Sponsor: University of Colorado, Denver

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Fig 1: Conceptual model of how Move+ components impact long-term weight loss, through SDT-constructs 
w 
COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
 
 
 
Protocol #: 22-2183 
Project Title: 
Designing with dissemination in mind: Development of a theory-based 
physical activity intervention using the Multiphase Optimization Strategy; 
Aim 1, Phase 2  
 
Principal Investigator:  Danielle M. Ostendorf, PhD 
Version Date: 3/29/23  
 
 
 
  
 
I. Hypotheses and Specific Aims:  A critical challenge in the prevention of cardiovascular disease 
(CVD) is increasing the proportion of adults who are able to lose weight and maintain their weight 
loss long-term.1 Physical activity (PA) is a key predictor of sustained weight loss2 and current 
guidelines recommend high levels of moderate-to-vigorous PA (MVPA, 300 min/wk) for weight 
management.3 However, long-term adherence to PA remains low in adults with overweight or 
obesity enrolled in lifestyle weight management programs.4-6 My previous work indicates that 
adults with overweight or obesity are more likely to adhere to PA when PA is consistent with their 
values and is perceived as enjoyable. This is consistent with Self-Determination Theory (SDT), 
which supports autonomous motivation as a critical factor in promoting sustained PA 
adherence.7-10 Based on my work, and the work of others11-14, I developed and piloted a brief, 
SDT-based, PA support program (called Move) in adults with BMI 25-45 kg/m2 who were enrolled 
in a 12-month lifestyle weight management program. Currently, Move consists of two, group-
based sessions that support autonomous motivation for PA by encouraging adults in choosing 
PA types that are personally meaningful and intrinsically motivated. Participants who attended 
both Move sessions demonstrated a greater increase in MVPA at 12 months compared to those 
who did not attend both Move sessions.  Focus group feedback (n=39) indicated high 
enthusiasm for Move, but also a strong desire for individualized support and additional Move 
content. Thus, the next step to refine this intervention is to add novel intervention components 
that target barriers to PA that were identified in the focus group feedback. We propose to create 
Move+ by developing 3 additional SDT-based components: 1) 1:1 support sessions (to provide 
individualized support), 2) guided positive exercise mental imagery sessions (to address negative 
feelings around PA), and 3) low-cost, livestream fitness membership (to improve PA access). We 
hypothesize that these Move+ components will improve autonomous motivation for PA15, which 
will lead to increased PA adherence, and thus long-term weight loss (Fig 1).  Our specific aim is: 
 
Aim 1 Phase 2: Pilot test the delivery of the Move+ program. We will conduct a 12-week, 
single-arm field trial to pilot test the delivery of the Move+ program. 
 
 
II. Background and Significance: The burden of obesity, associated with cardiovascular disease 
(CVD) and early mortality, will continue to be critical public health concern if the issues 
surrounding poor long-term weight loss maintenance are not addressed. Despite the short-term 
efficacy of lifestyle interventions for weight loss16 many individuals regain over half of their lost 
weight within two years.1 A high level of physical activity (PA; 250-300 min/wk moderate aerobic 

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PA) is a key predictor of weight loss maintenance5, 17-19 and is universally recommended for 
prevention of weight regain.20 In addition, increasing PA reduces risk for CVD, independent of 
weight loss.21, 22 
 
Despite the benefits of PA, getting adults with overweight or obesity to adopt and maintain high 
levels of PA long-term remains a significant challenge.4, 23 The vast majority (~90%) of adults 
with overweight or obesity enrolled in current lifestyle weight management programs do not meet 
PA guidelines for weight management long-term (≥12 months after start of intervention).5, 23-25 
Although many factors contribute to poor long-term PA adherence4, 26-29, absence of accessible, 
effective, theory-based programs that account for each person’s values30, motivation, and 
preferences31-34 remains a major barrier. Thus, there is a critical need for person-centered and 
scalable interventions that promote long-term adherence to PA in adults with overweight/obesity. 
 
I developed a brief, person-centered PA support program, called Move, designed to 
enhance explicit autonomous motivation for PA in adults with overweight or obesity. The 
Move program is based on the Self-Determination Theory (SDT) and targets enhanced PA 
adherence. Move supports autonomous motivation for PA by encouraging adults in choosing PA 
types that are personally meaningful and intrinsically motivated. SDT is compelling to focus on in 
the context of PA because it distinguishes the quantity from the quality of explicit motivation for 
PA. Autonomous motives, in contrast to controlled motives (e.g. rewards, guilt), are considered 
high-quality because PA is perceived to be consistent with individual values and inherent 
interests.35 The quality of explicit motivation is determined by the extent to which a context (e.g. 
exercise) satisfies 3 basic psychological needs: autonomy (actions are authentic and freely 
chosen), competence (feeling capable of achieving goals), and relatedness (connection to 
others).35 My work and the work of others has demonstrated that explicit motivation predicts PA 
adoption and maintenance.36 I found that adults with autonomous PA motives sustained their 
initial increases in PA at 12 months whereas those with controlled PA motives did not.37 These 
data, among others11-13, 38, suggest the importance of autonomous motives for PA adherence 
and provided key insight for Move. 
 
Move+ targets both explicit and implicit motivation, which may enhance PA adherence: 
PA motivation involves both explicit (conscious thoughts, autonomous motives) and implicit 
processes (automatic, may occur without awareness). Implicit attitudes towards PA represent an 
individual’s ‘gut’ reaction towards a PA stimulus (e.g. seeing a person running)39, can be positive 
or negative, and may occur without conscious awareness. There is increased evidence that 
these implicit processes are associated with PA behavior.40-44 Dr. Conroy (collaborator) is an 
expert in studying this association. In his study of 201 participants, implicit attitudes towards PA 
prospectively predicted device-measured PA 1 week later.41 Recently, the use of guided positive 
exercise imagery has been shown to impact implicit attitudes towards PA45 and to improve 
autonomous PA motives46, but it remains unclear whether changing implicit attitudes towards PA 
results in increased PA levels. This project will integrate guided positive exercise mental imagery 
as a novel Move+ intervention component to support long-term PA adherence. Thus, the 
proposed study is novel because our SDT-based PA program targets improved long-term PA 
adherence by changing both explicit and implicit motivation through our focus on PA enjoyment 
and positive affect, an approach that has not yet been applied in a weight management program. 
 
III. Preliminary Studies/Progress Report:   
 
Two Move sessions improved explicit autonomous motivation for PA and PA 
adherence over 12 months: As part of my F32 award (DK122652), I piloted Move 
in adults with overweight or obesity enrolled in a 12-month lifestyle weight 
management program with two, 60-min group sessions. In a preliminary analysis, 
participants who attended both Move sessions demonstrated 1) a significant 
increase in autonomous motivation for PA at 12 months (Fig 2A), and 2) were more 

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Fig 2A-B: Preliminary Data. Includes subjects who completed the 12-month study. B includes subjects who provided 
valid PA data (activPAL, ≥4 days; cadence ≥75) 
likely to meet the PA guidelines of ≥300 min/week of device-measured moderate-to-
vigorous intensity PA (MVPA) at 12 months (Fig 2B).  
 
 
 
 
 
 
 
 
 
 
However, participants were not randomized to receive Move and results are likely confounded by 
other factors, including overall attendance to group-based classes (78% vs. 60%, p<0.01). 
Importantly, qualitative data supports our intervention, as participants (n=39) reported high 
enthusiasm and acceptability for the Move program (abstract, ObesityWeek 2021). One 
participant stated: “You begin to enjoy [PA] because it becomes part of you. If you start moving in 
ways that you actually enjoy, it’s no longer a chore. It’s something that you just do.” Participants 
also indicated a strong desire for additional Move program content.  
 
IV. Research Methods 
The study will take place at the University of Colorado Anschutz Medical Campus (CU-AMC). The 
overall objective is to engage research partners to refine Move+ (Aim 1, Phase 2). Results will 
inform a future pilot feasibility trial of the refined Move+ intervention. 
 
A.  Outcome Measure(s):  To achieve Aim 1 Phase 2, quantitative and qualitative data will be 
collected. Human-centered design testing47, 48 will occur using a 12-week, single-arm field 
trial where a Registered Dietitian (RD) delivers ≥1 Move+ session per week (group-class, 
1:1, and/or guided imagery), remotely. Patients will receive a 12-week online fitness 
membership, using the option with the highest acceptability from cycle 1. Research 
partners recommendations will be used to refine intervention components. See Table 1 for 
a description of the assessments by research partner type. The primary study outcomes 
are acceptability and feasibility of the Move+ intervention. Other pre-specified study 
outcomes include exploring changes in SDT-constructs, explicit motivation for PA, implicit 
attitudes towards PA, weight, waist circumference, PA patterns, and cardiovascular 
markers. 
 
 
Table 1. Assessments for Aim 1, Phase 2 by Research Partner Type 
Outcome 
Measure 
Description 
Participants 
(n=9) 
RD  
(n=1) 
Week 
0 
12 
Acceptability 
90-min Semi-
structured 
Focus Group 
via Zoom* 
Explore acceptability; Identify 
any issues with the Move+ 
components 
x 
 
 
x 
Semi-structured 
60-min 
Interview49 via 
Zoom* 
Record reactions around 
acceptability using 
videoconferencing; identify any 
issues with the refined Move+ 
components 
 
x 
 
x 
Net Promoter 
Score (NPS)®50 
Scale -100 to 100; scores >0 
indicate good acceptability 
x 
x 
 
x 
Acceptability of 
Intervention 
Measures 
 
x 
x 
 
x 
A. Autonomous Motivation (PA Enjoyment) 
*p<0.05; **p<0.01 
B. PA Guidelines 
**
*

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(AIM)51 
Intervention 
Appropriatenes
s Measure 
(IAM)51 
 
x 
x 
 
x 
Likert scale (0-
10) 
Ratings of satisfaction for 
intervention component(s) by 
patients and staff every 3 weeks 
x 
x 
x 
x 
Feasibility 
Feasibility of 
Intervention 
Measure 
(FIM)51 
 
x 
x 
 
x 
Perceived 
Characteristics 
of Intervention 
Scale (PCIS)52 
PCIS measures trialability, 
relative advantage, 
compatibility, complexity, 
potential for intervention 
adaptation, etc. 
 
x 
 
x 
Organizational 
Readiness for 
Knowledge 
Translation 
(OR4KT)53  
Setting-level factors that 
influence program adoption 
(organization climate, 
organization context, change 
content, leadership, 
organizational support, 
motivation) 
 
x 
 
x 
Reach/Recruit
ment 
# of patients screened, 
proportion of eligible screens 
who enroll 
x 
 
x 
 
Treatment 
Adherence 
[# sessions attended/# 
provided], self-reported fitness 
membership usage  
x 
 
 
x 
Outcome 
Measure Rates 
[# patients who complete 
measures at each time point/# 
patients randomized] 
x 
 
x 
x 
Retention 
[# patients who complete 12-wk 
intervention/# patients who start 
the intervention] 
x 
 
 
x 
Fidelity and 
Adaptations 
Direct 
Observation 
Move+ sessions will be 
recorded, and the study PI will 
review recordings using an a-
priori checklist  
 
 
x 
x 
Physical Activity 
Patterns 
Accelerometer 
The activPALv4 (PAL) will be 
worn over 7 days to capture 
total stepping time, stepping 
time in MVPA, and sedentary 
behavior 
x 
 
x 
x 
Global Physical 
Activity 
Questionnaire 
(GPAQ) 
The GPAQ consists of 16 items 
which ask about the time spent 
doing different types of physical 
activity in a typical week 
x 
 
x 
x 
 
Exercise and 
Sleep Log 
Participants will be asked to 
record exercise and sleep over 
15 days 
x 
 
x 
x 
SDT-constructs 
Basic 
Psychological 
Need 
Satisfaction 
and Frustration 
Scale - 
Exercise 
(BPNSFS-E)54 
SDT-based; Assesses 
satisfaction vs. frustration with 
basic psychological needs for 
autonomy, competence, and 
relatedness with regards to 
engaging in physical activity (for 
participants) or teaching the 
program (for providers) 
x 
x 
 
x 
Explicit PA 
Motivation 
Behavioral 
Regulations for 
Exercise 
Questionnaire55 
SDT-based; Provides separate 
scores for each behavioral 
regulation for exercise 
(amotivation, external, 
introjected, identified, 
integrated, and intrinsic) 
x 
 
x 
x 
Implicit Attitudes 
Single 
A computerized, time sorting 
x 
 
x 
x 

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B. Description of Population to be Enrolled:   
 
B.1 Patient and Provider Partners: Two types of partners (n=10 total) will be recruited, 
applying strategies learned from participatory and research partner-engaged research 
methods: 
1. Adult participants with overweight or obesity seeking weight loss and/or 
improvements in health and well-being (n=9) 
Towards PA 
Category 
Implicit 
Association 
Test56 
task, which asks participants to 
rapidly indicate, whether each 
presented PA stimulus belongs 
to one of two attributes 
(good/bad) 
Imagery 
Vividness 
Vividness of 
Movement 
Imagery 
Questionnaire 
(VMIA-2)  
A 12-item questionnaire where 
participants rate each mental 
image in 3 ways (internal visual 
imagery, external visual 
imagery, and kinesthetic 
imagery) from 1 (perfectly clear 
and vivid) to 5 (no image at all) 
x 
 
x 
x 
Imagery Ability 
Movement 
Imagery 
Questionnaire 
(MIQ-3) 
A 12-item questionnaire to 
assess an individual’s ability to 
image four movements using 
internal visual imagery, external 
visual imagery, and kinesthetic 
imagery. 
x 
 
x 
x 
Weight Bias 
Weight Bias 
Internalization 
Scale Modified 
(WBIS-M)57 
An 11-item survey that 
measures the degree to which 
people apply weight-based 
stereotypes to themselves and 
base their self-evaluations on 
weight. 
x 
 
x 
x 
Body 
Dissatisfaction 
Figure Rating 
Scale (FRS) 
A 2-item survey that asks 
participants to rate their current 
body size and ideal body size. 
x 
 
x 
x 
Identity 
Physical 
Activity Identity 
A 4-item survey that asks about 
participant’s physical activity 
identity 
x 
 
x 
x 
Physical Activity 
Habit Strength  
Self-Report 
Index of Habit 
Strength 
(SRHI) 
Involves 12-items that assesses 
habit strength of physical 
activity. 
x 
 
x 
x 
Diet 
3-day Diet 
Record 
Record food intake over 3 days 
(including 1 weekend day) 
x 
 
x 
x 
COVID-19 
Tracking 
Survey 
A brief survey that asks about 
whether COVID-19 impacted 
participation in the study 
x 
 
 
x 
Anthropometrics 
Body Weight 
Digital scale accurate to ± 0.1 
kg 
x 
 
x 
x 
Waist 
Circumference 
Measured with a tape measure 
just over the iliac crest. 
x 
 
x 
x 
Height 
Measured with a stadiometer in 
cm 
x 
 
x 
 
Cardiovascular 
Markers 
Blood Pressure 
Automatic sphygmomanometer 
(average of 2 seated values 
taken after 5 min rest) 
x 
 
x 
x 
Cardiorespirato
ry Fitness 
Estimated using the YMCA 3-
minute step test protocol58 
x 
 
x 
x 
Note: All proposed quantitative measures have demonstrated adequate reliability and validity 
*Focus groups and interviews will also be used to explore feasibility 

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2. Providers, including Registered Dietitians (RDs) with experience delivering weight 
loss or lifestyle intervention curriculum (n=1) 
We will enrich recruitment of minority participants above the Denver metro proportions59 
(target ≥15% Black, ≥30% Hispanic). A sample size of n=10 was chosen because ~10 
research partners/cycle identify 95% of design issues.60 Special classes of participants 
considered vulnerable populations will not be included in the study.  Our primary 
recruitment strategy for this study will be university emails, recruitment from existing 
behavioral weight loss interventions (for participant partners), and through personal 
invitations (for RDs).  
 
B.2 Eligibility Criteria:  Eligibility criteria are designed to select a broad range of 
participant partners with overweight and obesity (women and men) for whom a physical 
activity program would be appropriate.   
 
To be eligible to participate in this research, volunteers must meet the following criteria: 
 
Inclusion Criteria: 
• For all types of research partners: 
o Men and Women 
o Age 18-65 years 
o Have access to a computer and/or smart phone, and Wi-Fi 
o Speak English 
• For the participant partners only: 
o Body Mass Index 25-45 kg/m2    
o Insufficiently active (defined as <150 min/week of voluntary exercise at 
moderate intensity over the past 3 months)  
o Willing not to enroll in any other formal weight loss, physical activity 
program, or fitness center membership over the next 5 months. 
o Have a primary care physician (or has access to a healthcare professional 
and/or are willing to establish care with a primary care physician prior to 
study enrollment) to address medical issues which may arise during 
screening or study procedures/interventions. 
o Capable and willing to give informed consent, understand exclusion 
criteria, attend the Move+ program sessions, and complete outcome 
measures. 
• For the provider partners only: 
 
>1 year experience with delivering lifestyle interventions involving changes 
in diet and/or exercise behaviors. 
 
Exclusion Criteria  
• For participant partners: 
o Considered high risk, based on the American College of Sports Medicine 
Guidelines for Exercise Testing and Prescription61 (i.e. have CVD 
symptoms or known CVD, diabetes, or end–stage renal disease).  
o Females who are currently pregnant or lactating, were pregnant within the 
past 3 months, or planning to become pregnant in the next 5 months will 
also be excluded 
o Self-reported cardiovascular disease: 
o Cardiac, peripheral vascular, or cerebrovascular disease 
o Self-reported symptoms suggestive of cardiovascular disease: 
• 
pain, discomfort in the chest, neck, jaw, arms, or other areas that 
may result from cardiac ischemia; shortness of breath at rest or 
with mild exertion; dizziness or syncope; orthopnea or paroxysmal 

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nocturnal dyspnea; ankle edema; palpitations or tachycardia; 
intermittent claudication.  
o Self-reported end-stage renal disease  
o Self-reported diabetes (history of type 1 or type 2 diabetes) 
o Uncontrolled hypertension, defined as diastolic blood pressure >100 
mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 
bpm as measured in duplicate at the screening visit after 5 minutes of 
rest in a seated position.  
o Self-reported pulmonary disease requiring chronic oxygen 
supplementation; severe asthma or chronic obstructive pulmonary 
disease requiring hospitalization in past year. 
o Plans to relocate in the next 4 months 
o Currently participating in or planning to participate in any formal weight 
loss, dietary modification, or physical activity/exercise programs or clinical 
trials. 
o Current severe depression or history of severe depression within the 
previous year, based on DSM-IV-TR criteria for Major Depressive 
Episode.  Score > 18 on BDI will require further assessment by the Study 
MD to determine if it is appropriate for the subject to participate in the 
study. 
o History of other significant psychiatric illness (e.g., psychosis, 
schizophrenia, mania, bipolar disorder) which in the opinion of the Study 
MD would interfere with ability to adhere to the exercise intervention. 
o History of clinically diagnosed eating disorders including anorexia nervosa, 
bulimia, binge eating disorder.  Score >20 on the EATS-26 or pattern of 
response on the QEWP-5 suggestive of possible binge eating disorder or 
bulimia will require further assessment by the Study MD to determine if it 
is appropriate for the subject to participate in the study. 
o Current alcohol or substance abuse 
o Nicotine use (current or past 6 months) 
o Regular use of prescription or over-the-counter medications known to 
significantly impact appetite, weight, sleep, or energy metabolism (e.g., 
appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic 
antidepressants) 
o Regular use of obesity pharmacotherapeutic agents within the last 6 
months. 
o Previous obesity treatment with surgery or weight loss device, except: (1) 
liposuction and/or abdominoplasty if performed > 1 year before screening, 
(2) lap banding if the band has been removed > 1 year before screening, 
(3) intragastric balloon if the balloon has been removed > 1 year before 
screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been 
removed > 1 year before screening or 5) AspireAssist or other 
endoscopically placed weight loss device if the device has been removed 
> 1 year before screening.   
o Has access to and currently uses (defined as having used membership at 
least once in past month) a fitness center membership. 
• For RDs partners: 
o None 
 
C. Study Design and Research Methods 
 
C.1 Screening 
Interested participants will complete an initial REDCap screening questionnaire containing 
demographic information (age, sex at birth, gender, race, ethnicity, etc.). For participants 
with an age >89, their age will be recorded as 89 in the study database. Participant 

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partners will also be asked to self-report their exercise levels, body weight, height, weight 
loss history, and health history. Potential participants will receive a follow-up call from a 
member of the research team to validate their information from the screening questionnaire 
and interest in the interviews. Research partners who meet initial eligibility criteria will be 
contacted by the study PI or PRA to confirm eligibility. Research partners will receive an 
explanation of the purpose of the study and study expectations, including research partner 
responsibilities and potential risks related to study participation. Interested individuals will 
be scheduled for an in-person screening visit to determine eligibility for the 12-week field 
trial. 
 
Participants will be asked to sign an eConsent via REDCap or Docusign if they agree to 
participate in the study. If a participant declines eConsent, they will be given the option to 
sign a paper consent in-person or remotely and email their signed consent to the study 
team. Following completion of informed consent procedures, potential participant partners 
will undergo a health history and physical examination. Health history and physical 
examinations will be performed by a qualified healthcare provider (Physician Assistant, 
Nurse Practitioner, or MD) to ensure that they meet study inclusion/exclusion criteria. Body 
weight and height will be measured to confirm the self-reported BMI. Resting blood 
pressure and heart rate will be measured. Participants will complete the Physical Activity 
Readiness Questionnaire (PAR-Q+)114 to screen for any contraindications to exercise. 
Participants will also complete the Beck Depression Inventory (BDI)62 to screen for 
depression, and the Eating Attitudes Test (EATS-26)63 and the Questionnaire on Eating 
and Weight Patterns (QWEP-5)64 to screen for eating disorders. Any screening results that 
preclude enrollment will be communicated to potential volunteers who will be 
recommended to consult with their primary care provider.  Participants who meet eligibility 
criteria will be invited to participate in the study.   
 
Study group assignment:  Phase 2 is a single arm, 12-week field trial, thus all participant 
partners will receive the Move+ program and there is no inactive control. 
 
C.2 Study Procedures 
 
C.2.1 Description of Move+ Intervention: The Move+ components are 1) group-based 
classes, 2) individual support sessions (for personalized support), 3) guided mental 
imagery sessions (to address negative feelings around PA), and 4) low-cost, virtual fitness 
membership (to improve PA access). I worked with Drs. Masters and Conroy to develop 
Move+ curriculum (see Table 2) that targets SDT constructs.65 The group-based sessions 
serve as the core curriculum for Move+, and three 1:1 support sessions help participants 
adopt the 3 PA messages from each group-based class into their daily lives. These 3 PA 
messages were inspired by a prior publication14. For the membership to livestream fitness 
classes, participants will receive 12-weeks, using the option with the highest acceptability 
from Aim 1 Phase 1 (COMIRB # 22-0147). The guided positive exercise imagery scripts 
were developed based on work from Williams et al.66 and prompt several sensory and 
emotional experiences.45 
 
Table 2. Description of Move+ Intervention Activities, Targeted SDT Constructs, and Organizational-Level Personnel 
for Intervention Delivery 
Component 
Move+ Activities 
Targeted SDT 
Constructs 
Organizational 
Delivery Mechanism 
Core Curriculum of Move+ Program 
Group-Based 
Classes 
There will be 1 introduction group-based class, in 
addition to the 3 group-based sessions. Each of the 
3, 60-min group-based sessions will focus on an 
autonomy-supportive PA message: 1) “All movement 
counts”, 2) “Move in ways that make you feel good”, 
and 3) “By moving more, you take better care of 
Autonomy, 
Relatedness, 
Competence 
Trained* Registered 
Dietitian (RD) teaches 
class via Zoom 
Videoconferencing 

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C.2.2 Delivery of Move+ Program: 10 research partners (9 patients, 1 RDN) will complete 
a single-arm 12-week field trial, where an RDN delivers ≥1 Move+ session per week 
(group-class, 1:1, and/or guided imagery), remotely. Patients will receive a 12-week online 
fitness membership, using the option with the highest acceptability from Aim 1 Phase 1 
(COMIRB # 22-0147). Research partner recommendations will be used to refine 
intervention components. Research partners will be compensated for their time in 
completing the 12-week single-arm field trial and the quantitative and qualitative measures. 
See Table 3 below for the schedule of delivery of components. 
 
Table 3. Schedule of Delivery of Move+ Program Components 
 
Intervention Week 
Program Component 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Introduction to the Study 
x 
 
 
 
 
 
 
 
 
 
 
 
 
Group-Based Class 
 
x 
 
 
x 
 
 
 
x 
 
 
 
 
Individualized Support Session 
 
 
 
x 
 
 
x 
 
 
 
x 
 
 
Guided Imagery Sessions 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Access to Online Fitness Center Membership 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
C.2.3 Physical Activity Prescription:  
Participants will receive a recommendation to gradually increase moderate intensity PA to 
150 min/week over the initial 12 weeks. This target is consistent with current PA guidelines 
for overall health67, 68. Participants will be instructed in how to use a relative intensity scale 
67 to achieve the target moderate intensity.   
 
D.   Description, Risks and Justification of Procedures and Data Collection Tools: 
 
Screening:  
Description: See detailed description in Section C.1 above. 
 
Justification and Risks: The primary risk from screening measures is diagnosis of a previously 
unknown disease. If a previously undiagnosed disease is found during screening or during any of 
the procedures, the PI will contact the participant and discuss the diagnosis and its ramifications, 
and when appropriate, the volunteer will be referred to their Primary Care Provider.  
 
Move+ Program and Exercise Prescription:   
yourself”. All group-based classes will be digitally 
recorded for fidelity checks. 
Additional SDT-based Move+ Components 
Individualized 
1:1 Support 
Sessions 
• 3, 45-min sessions to tailor PA messages & 
develop clear plan of action for PA  
• Encourage support of friends/family, demonstrate 
interest in person, use empathetic listening 
• All individualized support sessions will be digitally 
recorded for fidelity checks. 
Relatedness, 
Competence 
Trained* RD provides 
via Zoom 
Videoconferencing 
Online Fitness 
Membership 
• Choice in PA type: cardio, strength and 
conditioning, yoga, meditation 
• Opportunities for social support from other fitness 
members 
Autonomy, 
Relatedness 
Participants access 
online 
Guided 
Imagery 
• Weekly 3-5 min recorded sessions 
• Mental images of a positive, fun PA experience46 
and moving with confidence 
Autonomy, 
Competence 
Trained* RD provides 
online access to 
recordings to 
participants 
*Training will ensure RDs provide an autonomy-supportive environment and are confident in teaching PA content 

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Description: See detailed description in Section C.2 above. 
 
Justification and Risks: The exercise prescription is part of current guidelines for overall health.  
Subjects in will receive a recommendation to gradually increase moderate intensity PA to 150 
min/week over the 12 weeks.  This target is consistent with current PA guidelines for overall 
health67, 68.  Subjects will be provided an outline of weekly PA goals (min/week) to gradually 
progress to the target of 150 min/week by week 12.  Subjects will be instructed in the use of a 
relative intensity scale to achieve the target intensity as outlined in current PA guidelines67 
(moderate-intensity activity defined as a level of effort of 5 or 6 on a scale of 0 to 10, where 0 is the 
level of effort of sitting, and 10 is maximal effort).  The primary risks associated with beginning an 
exercise program are likely to be fatigue, shortness of breath, or muscle soreness during or after 
the training sessions.  It is expected that when these symptoms occur, they will be minor and brief.  
During exercise there is a small risk subjects may experience musculoskeletal injuries.  During 
exercise there is a small risk subjects may trip or fall.  During exercise there is a very small risk 
subjects will experience cardiovascular symptoms such as chest pain, shortness of breath, 
dizziness, syncope, or lower extremity claudication. 
 
o 
Risks of the exercise program will be minimized by ensuring all subjects meet the 
specific inclusion/exclusion criteria.  Subjects will have previously undergone a medical 
screening including medical history interview and physical exam, and assessment of 
blood pressure.  According to the most recent American College of Sports Medicine 
(ACSM) Guidelines for Exercise Testing and Prescription61, exercise stress testing 
prior to initiation of moderate or vigorous exercise is only indicated for high-risk 
individuals (i.e. individuals with symptoms of CVD or individuals with known CVD, 
diabetes, pulmonary disease, or end–stage renal disease).  Subjects with these 
conditions are excluded from our study, thus all subjects in our study will be classified 
as low- or moderate-risk by ACSM guidelines and thus routine screening exercise 
stress testing prior to exercise initiation is not recommended. 
o 
If subjects experience muscle soreness, we will prescribe light stretching, and hot/cold 
therapy to reduce the soreness.  If these approaches do not alleviate the soreness, we 
will advise the use of OTC pain relievers (e.g., aspirin, acetaminophen, ibuprofen), 
unless contraindicated.  It is anticipated that some subjects will experience soreness 
during the first few days of exercise, but since the recommended intensity is moderate 
we expect the symptoms will be minor and transient.  
o 
Although some minor to moderate orthopedic injuries may occur during the exercise 
program (primarily lower body musculoskeletal injuries such as muscle sprains, 
tendonitis, shin splints) given the moderate intensity and gradual increase of the 
exercise prescription we do not expect any severe injuries.  Subjects who experience 
minor to moderate orthopedic injuries will be allowed to remain in the study and return 
to exercise as tolerated. 
o 
Participants may feel uncomfortable about answering questions that are being asked 
group-based classes or individualized support sessions. Participants are not required 
to answer any questions.  To minimize this risk, we will notify participants that they are 
not required to answer any questions and that they may choose to leave the interview 
at any time. In addition, participants can ask to pause the recording at any time. Lastly, 
we will allow participants to send a chat privately to the interview moderator if they 
want to write down any thoughts or reactions that they would prefer not to share out 
loud, or that they didn’t have a chance to say. 
 
 
Qualitative Data: 
Description: At the end of the 12-week field trial participant partners will be asked to participate in a 
90-minute semi-structured focus group, and the RD partner will be asked to participate in a 60-
minute semi-structured interview. The focus group and interview will be conducted remotely, via 
Zoom Videoconferencing, a web conference software with full HD video and audio capability, or in-

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person. Zoom has wireless sharing, enabling users to access the platform via desktop or mobile 
device. Participants will have the option to connect to audio via phone or computer and can use 
their real name or a nickname or alias during the interview discussion to protect their privacy. Use 
of a web camera will be optional, with the understanding that it could reduce privacy. During the 
focus group or interview process, we will make every effort to protect subject privacy by only using 
first names in the group discussion. Any names included in the transcription will be changed to a 
de-identified study ID. The identity of subjects and the data acquired as a result of this study will be 
treated with professional standards of confidentiality. Only members of the research team will have 
access to information collected from the participants.  
 
Digitally recorded interview data will be sent to an outside company to be transcribed verbatim. 
Once we have verified the written documents, the recordings will be deleted. The typed 
transcriptions will be kept on a password-protected university server and any printed copies will be 
kept in a locked file cabinet in Dr. Ostendorf’s locked office. Data records will be maintained for at 
least 5 years after the publication of results. At that time, the PI may destroy the data records by 
deleting them from electronic media and by shredding paper documents, but some of the data 
records may be retained indefinitely. 
 
Sharing of data among investigators within the institution is typically facilitated either by providing a 
password for the database or by electronic transmissions. All members of the research group have 
individual computers that are part of the institution network with institutional oversight of security. 
Files that contain data that could jeopardize blinding to treatment code are password-protected to 
restrict access. Electronic transfer, in a manner that is compliant with regulations, typically 
facilitates sharing of data with investigators or monitoring personnel outside the institution. 
 
Semi-structured Focus Group: Topics that will be addressed in this focus group include 
participant experience with the Move+ program including feasibility/acceptability of each Move+ 
intervention component, assessment of cultural relevance, and feedback to refine Move+ 
components. Additional topics include facilitators and barriers for receiving the Move+ program. 
The study team will make decisions on the final Move+ program content based on research partner 
feedback. Thus, the final Move+ program content will reflect the wants and needs of the research 
partners. We will code for research partner comments that would result in a revision within each 
transcript. We will discuss all potential revisions within our study team meetings and collectively 
decide on which revisions to make outright, which revisions to develop a prototype for and go back 
to research partners for input, and which revisions to discard. As a study team, we will ensure that 
all revisions made to the program features are aligned with retain fidelity of the Self-Determination 
Theory. 
 
Semi-structured 60-minute Interviews: Topics that will be addressed in this focus group include 
RD experience with delivering the Move+ program including feasibility/acceptability of each Move+ 
intervention component, assessment of cultural relevance, and feedback to refine Move+ 
components. Additional topics include facilitators and barriers for delivering the Move+ program. 
 
Justification and Risks: Participating in a focus group or interview poses minimal risk. In addition, 
the subject matter of the interviews, Move+ acceptability/feasibility, is non-sensitive. This measure 
is required to assess our primary study outcome of interest: feasibility and acceptability of the 
Move+ program. As with all clinical research studies, there is the general risk of breach of 
confidentiality or data security.  To minimize this risk, only the minimal necessary data will be 
collected, and we will follow thorough procedures to maintain confidentiality. As part of the verbal 
consent process before each interview, we will ensure that each participant agrees that anything of 
a personal nature that is mentioned in the room will not be repeated to others outside of the 
discussion group. If anyone is not willing to give their consent to confidentiality, they may be 
excused from the group.  The risks to the subjects, including potential psychological risks from 
interview questions are minimal. Participants may feel uncomfortable about answering questions 
that are being asked in the interviews. Participants are not required to answer any questions.  To 

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minimize this risk, we will notify participants that they are not required to answer any interview 
questions and that they may choose to leave the interview at any time. In addition, participants can 
ask to pause the recording at any time. Lastly, we will allow participants to send a chat privately to 
the interview moderator if they want to write down any thoughts or reactions that they would prefer 
not to share out loud, or that they didn’t have a chance to say. If interviews are held in-person 
instead of remotely via Zoom Videoconferencing, we will hand out note cards to each participant 
that will be collected at the end of the session. These note cards can be used for participants to 
write down any thoughts or reactions that they would prefer not to share out loud, that they prefer 
not to be recorded, or that they didn’t have a chance to say. There is a slight risk of a time burden 
associated with participating in engagement activities. Subjects enrolled in this study will potentially 
benefit by learning information about strategies to improve their adherence to physical activity 
goals. The potential benefits of the study to the adult population may be significant. This study is 
expected to lead to an enhanced understanding of, and possibly new therapeutic treatments for, 
obesity treatment/prevention. In light of these potential benefits, the risks to subjects are 
acceptable. 
 
 
Outcome Questionnaires:  
Description: The following questionnaires listed below will be used to assess the primary and other 
pre-specified outcomes of the study. 
• 
REDCap Survey on Design Features: After the focus group occurs, research 
partners may be asked to complete a REDCap survey that asks for partner input on 
design changes for the Move+ program components. Research partners may be 
asked to select between two design options for a program component feature that is 
being considered for revision. Whichever option is preferred by more research 
partners will be selected for the refined Move+ program components. Program 
features that are selected by the majority of research partners will be used in the 
refined Move+ program components. If a feature splits users 50/50 then we will 
make revisions to the design options and re-survey research partners. If research 
partners continue to be split on a feature, we will not go past 4 iterative cycles of this, 
and the study team will make final decisions on program features, giving priority to 
the features that best operationalize Self-Determination Theory. 
• 
Acceptability of Intervention Measure (AIM): At the end of the 12-week field trial, 
research partners will be asked to evaluate each Move+ component using the AIM51 
with a 1-5 Likert scale (1=Completely Disagree, 5=Completely Agree). The AIM is a 
4-item questionnaire that asks research partners about whether the intervention 
component meets their approval, is appealing, whether they like it, and whether they 
welcome it’s use. The AIM demonstrated strong psychometric properties including 
content validity, discriminant content validity, reliability, structural validity, structural 
invariance, known-groups validity, and responsiveness to change.  
• 
Intervention Appropriateness Measure (IAM): At the end of the 12-week field trial, 
research partners will be asked to evaluate each Move+ component using the IAM51 
with a 1-5 Likert scale (1=Completely Disagree, 5=Completely Agree). The IAM is a 
4-item questionnaire that asks partners about whether the intervention component 
seems fitting, suitable, applicable, and/or like a good match. The IAM demonstrated 
strong psychometric properties including content validity, discriminant content 
validity, reliability, structural validity, structural invariance, known-groups validity, and 
responsiveness to change. 
• 
Feasibility of Intervention Measure (FIM): At the end of the 12-week field trial, 
research partners will be asked to evaluate each Move+ component using the FIM51 
with a 1-5 Likert scale (1=Completely Disagree, 5=Completely Agree). The FIM is a 
4-item questionnaire that asks partners about whether the intervention component 
seems implementable, seems possible, seems doable, and seems easy to use. The 
FIM demonstrated strong psychometric properties including content validity, 

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discriminant content validity, reliability, structural validity, structural invariance, 
known-groups validity, and responsiveness to change. 
• 
Weekly Survey: Every week during the 12-week field trial, patient partners will be 
asked to rate their satisfaction with specific program components that they received 
using a 1-10 Likert scale (1=Strongly Dislike, 10=Strongly Like), to describe their 
engagement with the virtual fitness membership and rate the classes they tried, and 
to provide any input for refinement/improvement. 
• 
Net Promoter Score (NPS): At the end of the 12-week field trial, research partners 
will be asked to evaluate each Move+ component using the NPS. The NPS is a 
single question with a 1-10 Likert scale: How likely is it that you would recommend 
the Move+ component to a friend or colleague? Respondents are grouped as 
follows: 1) promoters (score 9-10) are loyal enthusiasts who will keep referring 
others and fueling growth, 2) passives (score 7-8) are satisfied but unenthusiastic 
customers who are vulnerable to competitive offerings, and 3) detractors (score 0-6) 
are unhappy customers who can impede growth with negative word-of-mouth. The 
final NPS score is calculated as % promoters - % detractors. NPS scores range from 
-100 to +100, with scores >0 indicating good acceptability.  
• 
Perceived Characteristics of Intervention Scale (PCIS): At the end of the 12-
week field trial, the RD partner will be asked to complete the PCIS (e.g., completed 
in both phases 1-2). The PCIS is a 20-item scale that measures trialability, relative 
advantage, compatibility, complexity, potential for intervention adaptation, etc. The 
PCIS is a reliable measure of perceived characteristics of interventions, with some 
preliminary support for its validity.52  Participant partners will not be asked to 
complete this scale. 
• 
Organizational Readiness for Knowledge Translation (OR4KT) Questionnaire: 
At the end of the 12-week field trial, the RD partner will be asked to complete the 
OR4KT. The OR4KT is a 59-item survey that measures setting-level factors that 
influence program adoption (organizational climate for change, organizational 
contextual factors, organizational willingness to adjust to changes, leadership, 
organizational support, and motivation).53 Subscales are grouped into 6 dimensions: 
1) Organizational climate for change (10 items), 2) organizational contextual factors 
(10 items), 3) Change content (9 items), 4) Leadership (10 items), 5) Organizational 
support (10 items), and 6) motivation (10 items), followed by 1 open-ended question. 
The validity and reliability of the OR4KT will be assessed in real-life contexts of 
implementation of evidence-based changes in healthcare.53 Participant partners will 
not be asked to complete this scale. 
• 
Global Physical Activity Questionnaire (GPAQ) 69, 70: At baseline and week 12, 
patient partners will be asked to complete the GPAQ with showcards. The GPAQ is 
a 16-item interview-based questionnaire, where a research staff member will ask 
participants to estimate time spent doing different types of physical activity in a 
typical week. The research staff member will use showcards to help the participant 
understand types of activities considered moderate vs. vigorous intensity. 
• 
Basic Psychological Need Satisfaction and Frustration Scale - Exercise 
(BPNSFS-E)54: At week 12, patient partners and provider partners will be asked to 
complete the BPNSFS-E. The BPNSFS-E is a SDT-based questionnaire. It assesses 
satisfaction vs. frustration with basic psychological needs for autonomy, 
competence, and relatedness with regards to exercise through 12 items (e.g., “The 
way I exercise is in agreement with my choices and interests”) and a five-point Likert 
scale, where 1 = “I don’t agree at all” and 5 = “I completely agree”). This 24-item 
questionnaire has demonstrated validity71 and gender invariance.72  
• 
Behavioral Regulations for Exercise Questionnaire (BREQ-3)55: At baseline and 
week 12, patient partners will be asked to complete the BREQ-3. The BREQ-3 is 
SDT-based and provides separate scores for each behavioral regulation for exercise 
(amotivation, external, introjected, identified, integrated, and intrinsic). There are 24-

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items with responses that range from 0=”Not true for Me” and 4=”Very true for Me.” It 
has demonstrated validity and reliability.55, 73 
• 
Single Category Implicit Association Test (SC-IAT)56: At baseline and week 12, 
patient partners will be asked to complete the SC-IAT. The SC-IAT is a 
computerized, time sorting task, which asks participants to rapidly indicate, whether 
each presented PA stimulus belongs to one of two attributes (good/bad). The SC-IAT 
for physical activity has shown satisfactory internal consistency (i.e., reliability of the 
outcome score of trials within the same test)74, 75 Three scores will be calculated: D-
Score, DW-Score, and IP-Score. 
• 
Vividness of Movement Imagery Questionnaire (VMIA-2)76: At baseline and week 
12, patient partners will be asked to complete the VMIA-2. The VMIA-2 is a 12-item 
questionnaire where participants rate each mental image in 3 ways (internal visual 
imagery, external visual imagery, and kinesthetic imagery) from 1 (perfectly clear 
and vivid) to 5 (no image at all). 
• 
Movement Imagery Questionnaire (MIQ-3)77: At baseline and week 12, patient 
partners will be asked to complete the MIQ-3. The MIQ-3 is a 12-item questionnaire 
to assess an individual’s ability to image four movements using internal visual 
imagery, external visual imagery, and kinesthetic imagery. 
• 
Internalization of Weight Bias (WBIS-M): At baseline and week 12, patient 
partners will be asked to complete the WBIS-M. We will measure internalization of 
weight bias using the Weight Bias Internalization Scale – Modified (WBIS-M)57. This 
scale consists of 11 items and uses a 7-point Likert scale (1=strongly disagree; 
7=strongly agree). WBIS-M has demonstrated high internal consistency and strong 
construct validity. The WBIS-M also demonstrated significant correlations with body 
image, eating pathology, self-esteem, and symptoms of anxiety and depression, and 
was associated with these outcomes distinctly from anti-fat attitudes and BMI57. 
• 
Body dissatisfaction: At baseline and week 12, patient partners will be asked to 
rate their degree of body dissatisfaction. We will measure this using the Figure 
Rating Scale (FRS) developed by Stunkard et al78. Respondents are asked to 
choose the image that better represents their actual size. Then, they are asked to 
choose which image represents their ideal body size. The first is considered a 
measure of perception of one's body (current body image); the second is understood 
as an adherence to the ideals of beauty socially shared in the culture to which the 
respondent belongs (ideal body image). The discrepancy between the two is 
considered a good measure of body dissatisfaction. Positive scores are indicative of 
the desire to have a larger body size, while the negative ones are indicative of the 
desire to be thinner. The FRS has indicated good test—retest reliability and 
moderate correlations with other measures of body image dissatisfaction, eating 
disturbance, and overall self-esteem.79 
• 
Identity: At baseline and week 12, patient partners will be asked to rate their level of 
agreement for each physical activity identity statement. This will be measured using 
the Behavior Based Identity Questionnaire, which consists of 4 items. 80 
• 
Physical Activity Habit Strength: At baseline and week 12, patient partners will be 
asked to rate their level of agreement for each physical activity habit statement. The 
Self-Report Index of Habit (SRHI) Index Strength involves 12-items that assesses 
physical activity habit strength and automaticity81, 82. 
• 
Dietary Intake Assessment:  Dietary energy and fat intake will be assessed with a 
3-day dietary record. Participants will be asked to log food intake over 3 days 
including a weekend day.  
• 
Environment: Participants will be asked to report their home address, work address, 
and any changes in these addresses over the 12-week intervention. Home address 
and work address will be used to obtain census level data about the area in which 
they live and work, like access to parks and grocery stores. 

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• 
Medication Review: We will ask patient partners about the medications they are 
taking at baseline and week 12. 
 
Justification and Risks:  These questionnaires are required to assess the primary outcomes of 
acceptability and feasibility and other pre-specified outcomes of changes in SDT-based constructs 
and additional behavioral and psychosocial outcomes.  Subjects may find it inconvenient to 
complete the surveys.  There are no known risks associated with these procedures.   
 
Additional, Other Pre-Specified Outcome Measures: 
Anthropometric Measures 
Description: Body weight will be measured using a digital scale accurate to ±0.1 kg at baseline and 
week 12.  Height will be measured to the nearest 1 mm with a stadiometer at baseline.  Blood 
pressure will be measured with an automatic sphygmomanometer (average of 2 seated values 
taken after 5 min rest) at baseline and week 12.  Waist circumference will be measured at baseline 
and week 12 with a tape measure just over the iliac crest. 
 
Justification and Risks: These measures are required to assess our primary study outcomes of 
change in weight and BMI and there are no risks associated with these procedures.   
 
Patterns of PA and Sedentary Behavior 
Description:  The activPALv4 (PALTechnologies, Glasgow, Scotland) will be used to estimate time 
spent in moderate-to-vigorous PA (MVPA), light activity, and sedentary behavior over a 7-day 
period at baseline and approximately week 12.  The activPAL is a small (23.5 x 43 x 5 mm) and 
light (10 grams) device that uses accelerometer-derived information about thigh position to 
estimate time spent in different body positions (i.e., sitting/lying, standing and stepping).  The 
device is attached to the anterior thigh and is waterproofed by wrapping in a nitrile sleeve.  Thus, it 
can be worn during bathing and overnight, allowing for 24-hour measurement of wake and sleep 
behavior.  The activPAL was used in Dr. Catenacci’s K23 DK078913 in 114 participants; the device 
was well-tolerated with wear time averaging >23 hours/day83.  The time-stamped “event” data file 
from the activPAL software will be used to determine time spent sitting, standing, and stepping per 
day.  Using the activPAL program, the event data file will be converted to a second-by-second file 
and additional metrics of sedentary behavior (e.g., breaks in sedentary time, average duration of 
sedentary bouts, sleep time) and time in PA intensity category (sedentary, light and MVPA) will be 
estimated.  The activPAL estimates EE (METs) by 1) assigning MET values to sitting/lying and 
standing events and 2) estimating METs for stepping events.  Many studies have validated the 
activPAL for use in children, adolescents, and adults and report very high levels of accuracy (99-
100%) and no adverse events84-90.    Participants will also be asked to log all exercise during the 7-
day period they wear the activity monitor.   
 
Justification and Risks: This measure is necessary to obtain an assessment of patterns of free-
living physical activity, and sedentary behavior.  Subjects may find wearing the monitors 
inconvenient.  Rarely, mild to moderate skin irritation or rash can occur due to the activity monitors.  
If this occurs, the monitor will be discontinued, and the subject evaluated by the study PI.   
 
3 Minute Step Test (TMST) 
Description:  A TMST will be obtained as a surrogate measure of cardiorespiratory fitness.  In 
accordance with the YMCA TMST protocol58 participants will step on and off a 30.5 cm (12 inch) 
step 24 times per minute for 3 minutes. They will be aided by an electronic metronome set at 96 
beats per minute which they are to match with 96 steps (24 ascent-descent cycles) per minute. At 
one-minute intervals participants will be told “you are doing well” and the time remaining was 
indicated. Immediately after completion of the test participants rate their perceived exertion using 
the Borg (6 to 20) perceived exertion scale. Their cumulative heart rate will be determined by 
auscultation with a stethoscope during the first minute after test completion. 
 

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Justification and Risks:  The TMST predicts 50-90% of the variance in fitness as assessed by 
exercise treadmill V02 max testing and is thus an inexpensive surrogate for cardiorespiratory 
fitness, an important metabolic outcome measure. The TMST is also recommended by the ADOPT 
working group as an important predictor of response within weight loss interventional studies.  The 
primary risks associated with the TMST are likely to be fatigue, shortness of breath, or muscle 
soreness during or after the test.  It is expected that when these symptoms occur, they will be 
minor and brief.  During the TMST there is a small risk subjects may experience musculoskeletal 
injuries.  During the TMST there is a small risk subjects may trip or fall.  During the TMST is a very 
small risk subjects will experience cardiovascular symptoms such as chest pain, shortness of 
breath, dizziness, syncope, or lower extremity claudication.  Study staff will monitor the test and the 
test will be stopped if subjects experience any of these symptoms and subjects will be referred to 
their PCP or to the emergency room for further evaluation depending on the severity of symptoms.  
Risks of the TMST will be minimized by ensuring all subjects meet the specific study 
inclusion/exclusion criteria.  Subjects will have previously undergone a medical screening including 
medical history interview and physical exam, and assessment of blood pressure.   
    
D. Potential Scientific Problems:   
 
Making correct inferences when coding qualitative data: There is a risk of making 
incorrect inferences when coding the qualitative data. However, we will use an iterative 
process that involves moving back and forth between raw data and emerging themes 
multiple times, to ensure that participants’ experiences are accurately captured. We use a 
team-based approach to code the qualitative data. 
 
Compliance with Move+ Intervention:  We recognize adherence to PA will not be perfect 
and we do not expect it to be.  The research question we seek to address is not whether 
participants will fully adhere to the Move+ program, but rather whether the Move+ program 
components are acceptable and feasible.  
 
F.   Data Analysis Plan:   
 
F.1 Quantitative Data Analyses: Descriptive statistics will be performed on scale ratings 
with aspects of the Move+ program. Aspects of the Move+ program with less acceptable 
ratings will be targeted for refinement. Average scores <0 for the Net Promoter Score®, or 
<3 on any scale from the PCIS will indicate areas for refinement. Demographic information 
will be analyzed using descriptive statistics. We will also explore within-person changes in 
other pre-specified outcome measures from baseline to 12 weeks (e.g., PA, weight, waist 
circumference, blood pressure, cardiovascular fitness) using a paired samples t-test. 
Normality assumptions will be evaluated, and transformations used (e.g., square root and 
log) as appropriate.  P-values <0.05 will be considered significant.  No interim analysis is 
planned.   
 
F.2 Qualitative Data Analyses: Qualitative data from each cycle will be transcribed 
verbatim and analyzed using a rapid qualitative analysis approach and a traditional content 
analytical approach. The qualitative data software program ATLAS.ti will be used for data 
organization, management, and analysis. Consistent with established qualitative 
methodology, analysis of interview data will be a continuous, iterative process, beginning 
with initial data collection and continuing throughout and beyond the data generation 
period.91-93 We will use a rapid qualitative analysis to understand themes around specific 
domains (acceptability, feasibility, areas for improvement)94. A rapid qualitative analysis 
involves the use of a templated summary to summarize each transcript. Once templated 
summaries are complete, they are further condensed into a matrix to identify key points, 
potential themes, quality and consistency of data collection, directions for further data 
collection and analysis. A rapid qualitative analysis is used to obtain a quick understanding 
of what is in the data. In addition, order to achieve immersion, transcripts will be read 

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multiple times using a deductive approach guided by the Practical Robust Implementation 
and Sustainability Model (PRISM) and RE-AIM (Reach, Effectiveness, Adoption, 
Implementation, and Maintenance) frameworks95, 96, as well as an inductive, emergent 
approach in order to emphasize respondent perspectives and deemphasize investigator 
speculations93. Each transcript will be coded using a team-based approach (by Dr. 
Ostendorf and a trained Professional Research Assistant) within ATLAS.ti©.  Initial codes 
will be established, and any questionable codes will be discussed with the study team. We 
will look for comments/themes of acceptability and feasibility. The PI will meet with her 
mentors quarterly to discuss emergent new codes, themes, and patterns.97-99 
 
F.3 Mixed Methods Analyses: We will use an iterative convergent mixed methods 
design100 to integrate findings from the survey results with qualitative themes to identify 
intervention areas for refinement. We will look for parallel constructs/themes, identify 
differences and similarities, and create a joint display to array the integrated results.101, 102  
We will incorporate what we learn from Aim 1 to create a Move+ manual. Our goal is to 
package Move+ in a manner that it is 1) acceptable to participants and organizations to 
and 2) can be feasibly integrated into any existing lifestyle weight management curriculum. 
 
G.  Summarize Knowledge to be Gained:  Over two-thirds of US adults are afflicted with 
overweight or obesity.  Obesity is a serious and increasing public health problem. Physical 
activity is a key modifiable behavior, which may help promote weight loss and weight loss 
maintenance. Despite the benefits of physical activity, the majority of adults with 
overweight or obesity do not meet physical activity recommendations. Participants in 
lifestyle interventions typically adhere to behavior change recommendations initially, but 
this adherence steadily declines over time. Although many factors contribute to poor 
physical activity adherence, absence of accessible, effective, theory-based programs that 
account for each person’s values, motivation, and preferences remains a major barrier. 
The proposed study is designed to optimize a theory-based, person-centered physical 
activity program for adults with overweight or obesity. Developing novel approaches to 
improve physical activity adherence and promote weight loss and maintenance may 
potentially benefit many people. Identifying a feasible physical activity support program for 
adults with overweight or obesity could enhance our ability to treat obesity, as well as 
reduce the risk of chronic diseases, including cardiovascular disease.  Thus, the minimal 
potential risks to participants are balanced by the expected knowledge to be gained from 
this study. 
 
 H. References: 
 
1. 
Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a 
meta-analysis of US studies. The American journal of clinical nutrition. 2001;74(5):579-84. PubMed 
PMID: 11684524. 
2. 
Swift DL, Johannsen NM, Lavie CJ, Earnest CP, Church TS. The role of exercise and 
physical activity in weight loss and maintenance. Progress in cardiovascular diseases. 
2014;56(4):441-7. doi: 10.1016/j.pcad.2013.09.012. PubMed PMID: 24438736; PMCID: 3925973. 
3. 
Services USDoHaH. Physical Activity Guidelines for Americans. In: Services DoHaH, 
editor. 2nd Edition ed. Washington, DC, U.S.2018. 
4. 
Middleton KR, Anton SD, Perri MG. Long-Term Adherence to Health Behavior Change. Am 
J Lifestyle Med. 2013;7(6):395-404. doi: 10.1177/1559827613488867. PubMed PMID: 27547170; 
PMCID: PMC4988401. 
5. 
Jakicic JM, Marcus BH, Lang W, Janney C. Effect of exercise on 24-month weight loss 
maintenance in overweight women. Archives of internal medicine. 2008;168(14):1550-9; discussion 
9-60. doi: 10.1001/archinte.168.14.1550. PubMed PMID: 18663167; PMCID: 2829743. 
6. 
Catenacci VA, Wyatt HR. The role of physical activity in producing and maintaining weight 
loss. Nature clinical practice Endocrinology & metabolism. 2007;3(7):518-29. doi: 
10.1038/ncpendmet0554. PubMed PMID: 17581621. 

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7. 
Kok BE, Coffey KA, Cohn MA, Catalino LI, Vacharkulksemsuk T, Algoe SB, Brantley M, 
Fredrickson BL. How positive emotions build physical health: perceived positive social connections 
account for the upward spiral between positive emotions and vagal tone. Psychol Sci. 
2013;24(7):1123-32. Epub 2013/05/08. doi: 10.1177/0956797612470827. PubMed PMID: 
23649562. 
8. 
Notthoff N, Carstensen LL. Positive messaging promotes walking in older adults. Psychol 
Aging. 2014;29(2):329-41. Epub 2014/06/24. doi: 10.1037/a0036748. PubMed PMID: 24956001; 
PMCID: PMC4069032. 
9. 
Teixeira PJ, Silva MN, Mata J, Palmeira AL, Markland D. Motivation, self-determination, 
and long-term weight control. Int J Behav Nutr Phys Act. 2012;9:22. doi: 10.1186/1479-5868-9-22. 
PubMed PMID: 22385818; PMCID: PMC3312817. 
10. 
Kinnafick FE, Thogersen-Ntoumani C, Duda JL. Physical activity adoption to adherence, 
lapse, and dropout: a self-determination theory perspective. Qual Health Res. 2014;24(5):706-18. 
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