Physical Activity Promotion Based on Positive Psychology: Development and Piloting of a Novel Intervention Approach
Phase: NA
Conditions: Obesity, Physical Activity
Sponsor: Brown University

 
Study Protocol and Statistical Analysis Plan 
NIH #: 1R21CA224609-01A1  
Official Title: Positive Psychology for Physical Activity Promotion  
NCT #: NCT03826173  
Date of document: Approved by the Brown University IRB on March 12, 2018 
 
 

 
Engaging in regular physical activity (PA) is consistently inversely associated with risk of breast and colon 
cancers, 3-17 with additional evidence for suggesting PA helps prevent endometrial,18,19 pancreatic,20 and 
lung21,22 cancers. Despite these benefits, less than 5% of overweight and obese adults meet national 
guidelines for PA.44 Moreover, overweight adults spend less time in PA than normal weight adults,44-48 and are 
more likely to discontinue PA programs.49,50 Affect (feeling good/bad) is important for promoting regular PA, as 
those who respond with less positive affect during moderate intensity PA are less likely to adopt a program 
of regular PA.23-28 Additionally, those experiencing lower positive affect and higher negative affect outside the 
context of PA are less likely to engage in PA.29-34 Given the importance of positive affect for adoption and 
maintenance of regular PA, intervention componenents that focus on enhancing positive affect may be a 
valuable addition to standard PA promotion interventions. Specifically, interventions derived from positive 
psychology55 have shown promise in reducing depressive symptoms and increasing positive affect and are 
beginning to be applied to other areas of behavioral health.56-57 Consistent with the ORBIT model52 for 
developing behavioral interventions, the aims of this project are to, first, translate positive psychology theory 
into a 6-week, group-based positive psychology for PA promotion (PPPA) intervention for low-active 
overweight or obese adults (>18 years; BMI 25-40), delivered at local YMCAs, and supplemented with text 
messaging. We will deliver the intervention prototype among a cohort of 10 participants. Participants and 
investigators will provide ongoing feedback regarding their experiences with the intervention in an iterative 
development process to refine the protocol. Our second aim is to test proof-of-concept and feasibility of PPPA 
in the context of a randomized pilot study among 60 low-active overweight or obese adults at local YMCAs. In 
an additive design, participants will be randomized in a 2:1 ratio to PPPA versus a control intervention 
including only the standard PA promotion components of the PPPA intervention (i.e., PA education, self-
monitoring, and goal-setting), with equal frequency of staff contact and text message delivery. All 
participants will be followed for 6 months, and will receive a 6-month YMCA membership to equate access to 
PA facilities. We hypothesize that participants in PPPA, relative to the standard PA intervention will: 
demonstrate equal or greater session treatment retention and satisfaction (H1); and more min per week 
of PA as measured by accelerometry at immediate post-treatment (week 7) and weeks 13 and week 26 (H2). 
As a secondary aim we will examine effect sizes for PPPA versus the standard PA intervention on putative 
mediators that may underlie the efficacy of PPPA in improving PA outcomes, including positive and negative 
affect, optimism, happiness, life satisfaction, social support for PA, and PA enjoyment. The proposed research 
will set the stage for an RCT to test a novel PA promotion intervention that can be readily disseminated. 
 
 

 
Engaging in regular physical activity (PA) is an important cancer prevention behavior. A consistent inverse 
association has been shown for engagement in PA and risk and of breast and colon cancers, 3-17 with some 
evidence for endometrial,18,19 pancreatic,20 and lung21,22 cancers. As a result of the large and growing evidence 
base showing the protective effects of PA, NCI has emphasized funding for research on the development of 
PA promotion interventions to reduce risk of multiple cancers.2  
Despite the benefits of PA for cancer prevention, rates of regular PA are low, particularly among overweight 
and obese adults. Less than 5% of overweight and obese adults meeting national guidelines of expending 500-
1000 MET-minutes (intensity in metabolic equivalents times minutes) per week through PA of at least 
moderate intensity (64-76% of maximal heart rate (HR))35 and overweight adults spend less time in moderate-
to-vigorous PA,35-39 and are more likely than normal weight adults to discontinue PA programs.40,41  
Affect (feeling good/bad) plays an important role in promoting regular PA, as those who respond with less 
positive affect during moderate intensity PA are less likely to adopt a program of regular PA.23-28 Additionally, 
those experiencing lower positive affect and higher negative affect outside the context of PA are less likely to 
engage in PA.29-34 Given the importance of low positive affect for adoption and maintenance of regular PA, 
interventions based on positive psychology offer a promising means of enhancing PA promotion interventions.  
Positive psychology is a burgeoning area of research that may provide valuable and innovative directions 
for improving on PA promotion interventions.55 Building from a focus on personal strengths and the value of 
positive emotions and cognitions, interventions derived from positive psychology have shown promise in 
reducing depressive symptoms and increasing positive affect and are beginning to be applied to other areas of 
behavioral health.56-57 Most positive psychology interventions can be readily implemented with limited 
additional training and treatment resources and have the potential to appeal to a broad range of individuals 
given their emphasis on the near-ubiquitous human goal of enhancing personal happiness. Positive 
psychology interventions may increase levels of PA by emphasizing the potential physical and mental health 
gains associated with being more active, harnessing individuals’ personal strengths to address challenges to 
maintaining a program of regular PA, and providing techniques to savor positive events, social interactions, 
and social support for PA. Such intervention targets may directly impact PA behavior, and set off reciprocal 
effects among increased PA behavior, enhanced general positive affect, and PA enjoyment. 
The Aims of this project are consistent with the ORBIT model42 for developing behavioral interventions:  
Aim 1: Intervention development and refinement (ORBIT Phase 1): The first aim of the project is to 
translate positive psychology theory and research into a 6-week, group-based positive psychology for PA 
promotion (PPPA) intervention for low-active overweight or obese adults, delivered at local YMCAs, and 
supplemented with text messaging. The in-person session and text-messaging protocol will be based on the 
team’s previous and ongoing work developing and implementing positive psychology and smoking cessation 
interventions (Kahler, Bock), as well as our expertise in exercise promotion interventions (Williams; Bock). We 
will deliver the intervention prototype among a cohort of 10 low-active (< 60 min/week of structured PA) 
overweight or obese adults (>18 years; BMI 25-40). Participants and clinician-investigators will provide ongoing 
feedback regarding their experiences with application of the intervention in an iterative development process to 
refine the protocol, improve the utility of the intervention and modify intervention materials. The milestone for 
Phase 1 is a finalized PPPA intervention protocol by month 6 of year 1.   
Aim 2: Preliminary testing (ORBIT Phase 2): The second aim of the project is to test proof-of-concept and 
feasibility of PPPA. This will be accomplished in the context of a randomized pilot study among 60 low-active 
overweight or obese adults at local YMCAs. In an additive design, participants will be randomized in a 2:1 ratio 
to PPPA versus a control intervention including only the standard PA promotion components of the PPPA 
intervention (i.e., PA education, self-monitoring, and goal-setting), with equal frequency of staff contact and text 
message delivery. All participants will be followed for 6 months, including the 6-week treatment period, and will 
receive a 6-month YMCA membership to equate access to PA facilities. We hypothesize that participants in 
PPPA, relative to the standard PA intervention will: demonstrate equal or greater session treatment retention 
and satisfaction (H1); and more min per week of PA as measured by accelerometry at immediate post-
treatment (week 7) and weeks 13 and week 26 (H2).   
Secondary Aim: As a secondary aim we will examine effect sizes for PPPA versus the standard PA 
intervention on putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including 
positive and negative affect, optimism, happiness, life satisfaction, social support for PA, and PA enjoyment. 
Putative mediators will be assessed at mid-treatment (week 3), immediate post-treatment, and follow-ups.   
The proposed research will set the stage for a randomized clinical trial, which would be powered to test main 
effects and mediational mechanisms of action. Ultimately, we expect this program of research will result in a 
well-specified, efficacious PA promotion intervention that could be readily disseminated.  

 
A. SIGNIFICANCE 
A.1. Health benefits of physical activity for cancer prevention. The benefits of physical activity (PA) for 
cancer prevention are significant. Numerous large cohort studies and systematic reviews have shown 
consistent evidence of an inverse relationship between engagement in PA and risk and of breast and colon 
cancers, 3-17 with some evidence for endometrial,18,19 pancreatic,20 and lung21,22 cancers. Moreover, a recent 
pooled-cohort study of 1.44 million adults showed associations between leisure-time PA and 13 cancer types.1 
As a result of the large and growing evidence base showing the protective effects of PA, NCI has emphasized 
funding for research on the development of PA promotion interventions to reduce risk of multiple cancers.2  
A.2. Low rates of PA among overweight adults. Despite the many health benefits of PA, rates of regular PA 
are low, particularly among overweight and obese adults. Studies based on accelerometer data show that less 
than 5% of overweight and obese adults meet national guidelines of expending 500-1000 MET-minutes 
(intensity in metabolic equivalents times minutes) per week through PA.35 Moreover, overweight adults spend 
less time in moderate-to-vigorous PA than normal weight adults,35-39 and PA promotion studies have shown 
that overweight adults are more likely to discontinue PA programs and discontinue them sooner.40,41 Thus, 
there is an urgent need to improve adherence to PA programs among low-active overweight and obese adults. 
A.3. Importance of affect for PA promotion. Affect (feeling good/bad) is important for promoting regular PA. 
First, although both acute sessions of PA and participation in regular PA can result in increases in positive 
affect,43,44 findings from our group23,24 and others25-28 have shown that those who respond with less positive 
affect during moderate intensity PA are less likely to adopt a program of regular PA as assessed 6 and 12 
months later. Importantly, the latter effects have been shown even when controlling for affect assessed 
immediately prior to PA, thus illustrating that a less positive affective response to PA is predictive of poorer PA 
adherence. Second, research from our lab29 and others30-34 has shown that those experiencing lower positive 
affect and higher negative affect outside the context of PA are less likely to engage in PA. Thus, low positive 
affect and high negative affect experienced outside the context of PA are likely to be significant barriers to PA 
adoption. Given the importance of low positive affect for adoption and maintenance of regular PA, interventions 
based on positive psychology offer a promising means of enhancing PA interventions. 
A.4. Positive psychology interventions. Positive psychology calls for a balanced approach to addressing 
behavioral health that focuses not only on ameliorating deficits and addressing psychological suffering but also 
building on strengths and promoting flourishing.45  Accordingly, positive psychology interventions (PPIs) “aim to 
cultivate positive feelings, behaviors, or cognitions.”45 The majority of PPIs have been directed at decreasing 
depressive symptoms and enhancing positive affect and well-being.46 A meta-analyses encompassing 51 
studies, indicated that PPIs enhance well-being (r = .29) and decrease depressive symptoms (r=.31).46 A 
second meta-analysis of PPIs including only RCTs with long-term follow-ups found standardized mean 
differences of .34 for subjective well-being, .20 for psychological well-being, and .23 for depression.47 
PPIs are now being tested in the broader context of behavioral medicine, including trials of PPIs for family 
care-givers of people with dementia (R01, NINR), adolescents with Type I diabetes (DP3; NIDDK), youth 
substance abusers (R21; NIDA), people recently diagnosed with HIV (R01; NIMH), and cardiac patients (R01; 
NHLBI), including our research team’s ongoing work applying PPIs to individuals with chronic pain,48 and 
adolescents with suicidal ideation (R34MH101272). Promising results have been reported recently for positive 
affect-focused interventions to improve health behaviors in patients with hypertension and cardiopulmonary 
disease49-51 and to reduce stress in healthcare practitioners.52 As we describe below (Preliminary Studies), our 
team conducted a treatment development study53 and pilot randomized controlled trial54 of a smoking cessation 
treatment incorporating PPIs, with promising results, and we are now conducting an RCT comparing a PPI for 
smoking cessation plus text messaging versus a standard smoking cessation intervention (R01 CA201262).  
A.5. Positive psychology for PA promotion. We propose to incorporate PPI techniques into a community-
based PA promotion intervention: Positive Psychology for Physical Activity (PPPA). Our approach has a strong 
scientific premise, with multiple potential mechanisms of action specifically designed to target the low positive 
affect that is a barrier to PA promotion (Figure 1). First, 
evidence shows that engaging in regular PA is likely to 
result in significant affective gains outside the context 
of PA, including increased positive affect,43 quality of 
life,55 and happiness,56 and reduced risk of 
depression,57 depressive symptoms among healthy 
adults,58 and anxiety.59 On the other hand, many 
people, particularly those who do not engage in regular 
PA, experience an acute negative affective response 

 
during PA.24,60 A positive psychology-based approach to PA promotion can build upon these data by gain-
framing PA as part of an effort to increase both physical and mental health, while still acknowledging the 
challenges associated with acute negative affective responses during PA. This is similar to the approach we 
have taken with positive psychology and smoking cessation.53,54 Second, a focus on accentuating 
individuals’ strengths in the context of PA promotion may enhance intervention engagement. For example, 
positive self-affirmations61 have been shown to reduce stereotype threat,62 reduce biased evaluation of 
information,63 and reduce defensiveness about health information leading to increased behavioral intentions.64 
Third, PPIs that focus on savoring of positive events and positive social interactions help to further 
enhance positive affect and provide a valuable counter to negative affect that may undermine PA adherence.65 
Emphasis on positive social interactions includes recruitment of social support and decreased loneliness, 
which are predictive of adherence to PA programs.66,67 These three intervention targets are posited to directly 
impact PA adherence and to further increase PA behavior through enhancing overall positive affect and PA 
enjoyment. Increases in positive affect outside the context of PA and PA enjoyment can improve efficiency of 
thinking and the ability to consider behavioral options for increasing PA, and build social and psychological 
resources that provide a buffer against future stress.68-72 Indeed, an analysis of three clinical trials with patients 
with cardiovascular disease and asthma indicated that a positive affect intervention buffered against the effects 
of stress on reduced PA.51 Thus, increases in overall positive affect and PA enjoyment will serve to increase 
adherence to PA programs. Increases in PA will, in turn, have a reciprocal effect on positive affect and 
PA enjoyment, thus creating a feedback loop for positive affect, PA enjoyment, and PA adherence. 
A.6. Community-based physical activity promotion. In order for PPPA to ultimately have high public health 
impact, the intervention must be readily conducted in community settings with an eye towards future 
dissemination.  For this project, we are focusing on delivering the intervention in the YMCA setting. The 
YMCA is a non-profit organization with a mission to increase the health of their clientele. There are 2,700 
YMCA branches nationwide, which serve a diverse clientele in large part due to their sliding-scale policy for 
membership fees. Partnership with the YMCA at this stage of intervention development will ensure that the 
program is conducive to a community-based setting that will ultimately allow for widespread dissemination. 
A.7. Use of text messaging to enhance compliance with positive psychology exercises. Development of 
PPPA must include easy-to-disseminate approaches to maximize participants’ engagement in the ongoing 
exercises that must be completed outside therapy sessions—i.e., homework. In our team’s prior work using 
PPIs for smoking cessation, a substantial portion of participants reported engaging only sporadically in 
homework, often citing “forgetting” as a key reason for nonadherence. Therefore, in our recent pilot work and 
now in our ongoing NCI-supported clinical trials, we have incorporated text messaging as a means of 
regularly prompting participants to complete PPI homework. Text messaging is a relatively simple and low 
cost technology73 that has widespread use and popularity.74 Pew Research estimates that 95% of adults in the 
US own a cell phone, including 94% of non-Hispanic whites, 94% of Blacks and 98% of Hispanics; over 99% of 
those under age 50, 97% of those 50-64, and 80% of those 65 or older. Even among the lowest income 
groups, 92% own cell phones. Over 80% of all cell phone users regularly use text messaging.75 Thus text 
messaging offers considerable reach across diverse populations. Moreover, text messaging has been 
increasingly used in health promotion research,76,77 with meta-analyses showing favorable effects.78-80 
B. INNOVATION 
Positive psychology and the development of PPIs represents a shift from traditional social-cognitive-based PA 
promotion programs towards a focus on enhancing well-being and accentuating individual strengths.45,81,82 We 
are not aware of any previous studies that have tested a positive psychology approach to PA 
promotion. Health behavior researchers have just begun to describe the potential innovative contributions 
positive psychology can make to health behavior interventions.83 Moreover, use of PPIs to enhance PA is likely 
to have high appeal given that people across nations list happiness as a top priority in terms of life goals84 and 
so such a focus may enhance treatment engagement.81 We propose to integrate the framework of positive 
psychology throughout PA promotion counseling, creating a highly innovative protocol that builds from a clear 
conceptual model of intervention effects. Additionally, while the use of text messaging is not innovative in 
its own right, this project is innovative in its use of text messaging to increase engagement and allow 
completion of homework exercises through texts. Initial data suggest participants prefer to complete PPI 
homework exercises with text messages rather than traditional written forms. The text messaging program also 
is innovative in its ability to allow users to choose which PPI exercises to continue and to provide day-level 
data to counselors regarding homework completion. Use of text messaging is likely to enhance the effects of 
PPPA in a cost-effective and disseminable manner and provide valuable data on the extent to which 
participants engage in the PPI exercises and how this engagement predicts PA adherence. 

 
C. APPROACH 
C.1. Preliminary studies 
C.1.a. Behavioral interventions for physical activity promotion. Bock (Co-I), Williams (PI),  and colleagues 
have developed and repeatedly tested an individually tailored PA promotion intervention designed to help 
previously sedentary and low-active adults overcome barriers to regular PA. The intervention has been 
delivered through multiple media (e.g., print, internet, phone) and has repeatedly shown efficacy in increasing 
PA.85-90 This research demonstrates our track record of PA promotion research among community volunteers, 
including extensive experience with recruitment, screening for PA contraindications, delivery of behavioral 
interventions, PA-related assessments (e.g., accelerometry), and participant retention.  
C1.b. Development and evaluation of positive psychology interventions. Our consultant, Dr. Parks, was 
one of the early pioneers in the development and validation of PPIs. In her first study, a 6-week group-based 
PPI was delivered to college freshmen with mild to moderate elevations in depressive symptoms.81 Participants 
showed significantly greater reductions in depressive symptoms than control participants through 1-year follow-
up. Findings were replicated in a second study among a more age-diverse group including non-students.91  
C.1.c. Positive psychology for smoking cessation. Kahler (Co-I) has an ongoing collaboration with Parks 
(Consultant) using PPI strategies for smoking cessation. In an initial study (1R01CA156241) Kahler and Parks 
developed a structured manual for Positive Psychotherapy for Smoking Cessation (PPT-S), which participants 
received favorably and which was modified based on patient and clinician-investigator feedback53 prior to 
launching a successful pilot randomized trial (N=66).54 Participants in PPT-S had significantly higher odds of 
abstinence (OR=2.75; p=.046) compared to those receiving standard treatment, and greater use of PPT-S 
strategies was associated with a less steep decline in smoking abstinence rates over time (OR=2.64; p=.04), 
suggesting that PPT-S had a positive effect on successful behavior change maintenance. 
C.1.d. Text messaging and positive psychology. Over the past two decades, Bock (Co-I) has been 
conducting studies that use technology (e.g., videogames, mobile phones, expert systems, Internet, text 
messaging) applied to behavioral assessment and intervention. Kahler and Parks have recently partnered with 
Bock to develop a text-messaging component for their PPT-S intervention (i.e., PPT-S+). Based on feedback 
and pilot testing, the messages in PPT-S+ were reduced in frequency so that the number of messages does 
not become burdensome. Responses to piloting of PPT-S+ with 8 smokers have been positive. Participants 
responded to 83% of messages, with 7 participants indicating they prefer to complete exercises by text rather 
than using pen and paper, and one indicating no preference. Kahler, Bock, and Parks are currently testing 
PPT-S+ in an RCT. In the proposed research, we will use the same iterative methods used to develop PPT-S+.  
C.1.e. Previous and ongoing partnerships with the Greater Providence YMCA. Williams (PI) has previous 
and ongoing collaborations with Ms. Taylor (Consultant), Vice President for Healthy Living and Membership for 
the Greater Providence YMCAs, including delivery of PA promotion and smoking cessation programs through 
multiple Greater Providence YMCA branches (R01 CA155381; R03CA188473; R01 DA21729).92-94 Thus, the 
YMCA is a natural partner for development and preliminary testing of the PPPA program.  
C.2. Procedures for Aim 1: Intervention development and refinement (ORBIT phase 1) 
C.2.a. Overview. For Aim 1 (months 1-6), we will first develop a PPPA intervention prototype and 
corresponding treatment manual based on our existing PPT-S+ intervention and our extensive experience with 
PA promotion interventions. We will then test the preliminary 6-session PPPA intervention with 10 participants 
in a group format at two local branches of the Greater Providence YMCAs serving central (Kent County) and 
northern (Mount Hope) RI. The Research Interventionist (RI) will conduct the treatment sessions, which will be 
audio-recorded and reviewed by Kahler, Bock (Co-Is), and Parks (Consultant) to provide ongoing feedback 
and suggestions. We will also solicit feedback from participants at the end of each in-person session. 
Adaptation of the intervention and treatment manual will be ongoing during this stage. 
C.2.b. Recruitment and screening. We will recruit 10 overweight or obese (BMI: 25-40) adults (>18y) through 
newspaper, internet, and radio advertisements. We will actively recruit minority women and men through 
targeted newspapers and radio stations. Participants must be sedentary or low-active, defined as < 60 
min/week of structured PA. Exclusion criteria will be history of coronary artery disease, stroke, uncontrolled 
hypertension or asthma, COPD, diabetes, osteoarthritis or orthopedic problems that limit PA,. Adults with BMI 
> 40 will be excluded given the increased risk of unsupervised PA in these populations.95 Only one participant 
per household will be permitted. Smokers will be eligible, with smoking status included as a covariate in a 
future RCT. Participants must be able to receive and respond to a text message at the time of screening.  
C.2.c. Orientation, baseline assessment, and YMCA membership. Individuals who are eligible on an initial 
phone screen will be asked to attend an orientation session at the local YMCA where the Research Assistant 
(RA) will provide more information about the study, and the opportunity to ask questions prior to signing 

 
consent. After orientation and consent, the RA will obtain height and weight, and observe participants use of 
YMCA aerobic exercise equipment to ensure adequate capacity for moderate intensity PA. Participants who 
remain eligible following baseline assessments will take with them an accelerometer to assess baseline 
frequency, duration, and intensity of moderate-to-vigorous PA (MVPA) over a one-week period. Orientations 
will be group-based and ongoing until 15 participants are eligible, thus allowing for a minimum of 10 
participants in the PPPA intervention group. We expect to achieve this number within 2-3 weeks of recruitment. 
Participants will be provided a 3-month YMCA membership upon arrival at session 1 of the PPPA intervention.  
C.2.d. Primary treatment components. There will be 6 weekly one-hour PPPA treatment sessions consisting 
of core PA promotion content and positive psychology content. All participants will receive a treatment binder 
that contains information about each session. Core PA promotion content will be based on our previous PA 
promotion studies, and will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions 
based on age and resting heart rate, and instruction on how to gauge PA intensity, (c) goal-setting and self-
monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be 
instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines.96 PA content will 
be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will 
continue throughout the 6-week period. Positive psychology content: The exercises listed below begin in 
session 1 and will continue throughout the 6-week program, with PPPA homework completed via text-
messaging. Specific content for each session will be determined upon development of the intervention manual. 
PPPA model of PA promotion. In the PPPA model, success in maintaining regular PA is influenced by 
perceived physical and mental health benefits of PA, overcoming negative associations with PA, social and 
environmental factors, and personal factors such as commitment to PA, optimism, satisfaction with the past, 
and positive emotions. Examples of how PPPA will address each of these areas will be provided. Participants 
will be told that the combination of positive psychology strategies and regular PA can help develop and 
enhance pleasure, happiness, and meaning in life. Positive introductions. PPPA will begin by introducing the 
concept of signature strengths and how those can be important in adhering to a program of regular PA. 
Participants are provided feedback about their 5 signature strengths based on the Values in Actions Survey97 
and asked to share (via texting) how they demonstrated one of their strengths. Using signature strengths. 
Treatment providers highlight the role that signature strengths play in leading an engaged life and assign 
participants to find new ways to employ their signature strengths in their daily life. This treatment element has 
been empirically demonstrated to decrease negative affect and increase happiness.82 In PPPA, participants 
are also asked to consider how they can employ their signature character strengths to help them manage 
barriers to regular PA. Three good things. Participants are instructed to text about three good things that 
happened each day and their causes. This exercise has been shown to have rapid and lasting effects on 
reducing negative affect and increasing happiness82 and has been employed successfully via text 
messaging.98 Savoring. Treatment providers introduce the concept of savoring positive experiences. 
Participants are asked to savor at least two experiences each day for one week and text back their response to 
evening text prompts regarding homework completion. Active/constructive responding. Participants are 
instructed to listen carefully when people they care about report good events. They are instructed to stop and 
go out of their way to respond actively and constructively to these events and to keep a record of these 
experiences via nightly texting. Commitment and gratitude discussion. This exercise involves selecting an 
important support for PA, discussing with that person the reason one is grateful to them and the reasons they 
appreciate them, and asking for specific support for increasing and maintaining regular PA. 81,82 Maintenance 
of happiness. In the final session, participants discuss their experiences with PPPA and generate ways that 
they can modify these experiences in order to keep using them in their lives. They then choose one or two 
exercises to continue over the following months after treatment. Text messaging: Participants in PPPA will 
receive daily texts. Morning texts provide static messages relevant to a given PPPA exercise, while evening 
texts are interactive and ask for open-ended descriptions of what participants did to complete that day’s PPPA 
exercise, with a reminder sent after 1 hour if no response is received. These responses are tabulated for the 
counselor. Text messages specific to a PPPA exercise are initiated at the respective counseling session at 
which that PPPA exercise is introduced by texting a key word, e.g., ‘Savor’ to initiate the savoring texts. The 
PPPA exercise continues each day following the session until that exercise is replaced by a new exercise. At 
session 6, participants choose which PPPA exercises they want to continue and receive texts based on their 
choice for an additional 2 weeks. Participants are also given forms for completing exercises on paper if they 
prefer to write longer responses or won’t have cell phone access. Text messaging platform. We will build on 
the text-messaging platform developed by Co-I Bock and currently being used by Kahler and Bock.99 This 

 
program enables users to request additional support messages and uses two-way texting. This beta version 
has been successfully piloted, allowing us a quick time to start-up. 
C.2.e. Interventionist characteristics and training. The characteristics of the interventionist have 
implications for ultimate dissemination of the Positive Psychology for PA (PPPA) program should it show initial 
efficacy. A bachelor’s-level RI will conduct the treatment, with oversight from the investigative team. The RI will 
be similar in training and experience to the community-level staff that we expect would ultimately deliver the 
treatment in a future effectiveness trial and upon dissemination of the program. Treatment manuals will be 
developed to ensure consistent delivery of the PPPA and Standard PA promotion (SPA) interventions. The RI 
will practice the treatment protocol with other staff and students until it is delivered consistently. 
C.2.f. Treatment fidelity. A treatment fidelity checklist will be created for each session and completed at the 
end of each session by the RI. Additionally, all treatment sessions will be audio-recorded. Review of recordings 
along with a second completion of the checklist will be split among Williams, Kahler, and Parks, who will meet 
weekly with the RI to discuss any deviations from the treatment protocol. Although we do not expect deviations 
from the protocol, any such deviations will be addressed by the PI, with the RI retrained as needed. Weekly 
meetings will also be used to assess strengths and weaknesses of treatment components and suggest 
revisions to the protocol that will be implemented in the next phase of research (see below).  
C.2.g. Assessment timeline. Assessments will be conducted at baseline, ongoing during the 6-week PPPA 
program, at week 7 (one week after the final PPPA intervention session) and at week 13 (3-month follow-up). 
C.2.h. Measures. Demographics will be collected at baseline, including gender, ethnicity/race, education, 
marital/relationship status, income, and employment. PA outcomes: Total volume of MVPA (i.e., min of MVPA 
weighted by intensity) expressed in MET minutes will be determined by accelerometers (Actigraph wGT3x-BT) 
worn during one-week periods at baseline (prior to the start of treatment), immediate post-treatment, and 3-
month follow-up. Accelerometers will be worn on the right hip at the anterior axillary line using an elastic belt, 
consistent with standard practices.100  Instructions, including proper positioning, will be provided in person at 
baseline and again at the final, week 6, PPPA session. As our team has done in previous studies,101,102 we will 
use ActiLife software to determine PA intensity.103 However, we will also be collecting raw accelerometry 
output data thus allowing for consideration of alternative cutpoints (e.g.104-106) and/or data processing 
approaches (i.e., pattern recognition107) as the literature develops. MVPA will also be self-reported in diary form 
over the 7-day accelerometer period. This procedure is standard in the field, as it helps to verify accelerometry 
outputs and also accounts for MVPA that is not easily recorded by the accelerometer (e.g., stationary bicycle).  
Intervention feasibility and acceptability: We will record PPPA session attendance and responses to the 
evening text-messages as objective indices of feasibility and acceptability. Retention will be coded as a 
dichotomous variable with participants who complete the sixth and final treatment session characterized as 
treatment “completers” and those not attending the final session as “non-completers.”  Participants will 
complete a Treatment Strategies Questionnaire at sessions 2-6, which will assess frequency of use of specific 
PPPA strategies in the past week such as planning opportunities for PA and completing the 3 Good Things 
exercise.108 Responses to the questions will be used to inform the treatment feedback process. Satisfaction will 
also be assessed with the Client Satisfaction Questionnaire, an 8-item questionnaire that will be administered 
at the 7-week follow-up to assess participant satisfaction with provided services (CSQ-8).109 Positive 
psychology measures and putative mediators: The Values in Action Survey97 will be administered to all 
participants at baseline, and participants will receive feedback on their 5 “Signature Strengths” derived from 
this measure.81,82 The following putative mediators will be assessed at mid-treatment (session 3), post-
treatment (week 7), and 13-week follow-ups. Short-term changes in positive and negative affect will be 
assessed with the Positive and Negative Affect Scale.110 Trait optimism will be assessed with the well-validated 
revised Life Orientation Scale.111 Subjective happiness and subjective well-being will be assessed with the 4-
item Subjective Happiness Scale112 and the 5-item Satisfaction with Life Scale.113 Social support will be 
assessed at baseline and follow-ups using the 13-item Social Support for Exercise Scale.114 Finally, PA 
enjoyment will be assessed with the 18-item Physical Activity Enjoyment Scale.115 
C.2.i. Intervention refinement. During the initial PPPA intervention group, the intervention manual and 
materials will be refined based on an iterative treatment development process. After each of the sessions is 
completed, participants will complete brief questionnaires on perceived session utility and their use of PPPA 
strategies in the past week. Open-ended questions will also assess the utility and acceptability of the treatment 
sessions and exercises. Intervention refinement will also be based on investigators’ weekly reviews and 
discussion of the audio-recorded sessions. This will lead to a revised PPPA manual going into Phase 2. 
C.3. Additional procedures for Aim 2: Preliminary testing (ORBIT phase 2). 
Procedures for Aim 2 will be the same as Aim 1, with the following exceptions: 

 
C.3.a. Recruitment, enrollment, and randomization. We will recruit 60 participants who will be randomized 
at a 2:1 ratio to PPPA treatment versus standard PA promotion (SPA) in order to focus resources on the 
PPPA program while still including a comparison for preliminary testing. We will run 4 groups of PPPA and 2 
groups of SPA, with 10 participants per group. Urn randomization will be used to balance on sex and BMI.  
C.3.b. PPPA condition. The PPPA condition will follow the revised treatment manual and text messaging 
program, based on feedback from Aim 1, but will follow the basic themes and procedures noted above.  
C.3.c. SPA condition. The SPA condition will consist of the core PA promotion content (see above). To 
equate for session duration, additional information on health and wellness will be delivered by the staff, 
including topics such as skin care, alcohol use, and heart health. Text messages for the SPA condition will 
consist of reminders to engage in PA and other general motivational messages, thus controlling for total 
number of text messages. Because all of the PA-related content in the SPA condition will also be provided in 
the PPPA condition, this is essentially an additive design, with an equal contact control.  
C.3.d. Additional 6-month follow-up and 6-month YMCA membership. For both conditions, YMCA 
memberships will be extended for 6 months, and an additional assessment will take place at month 6 (wk 26). 
C.4. Participant retention, compliance, and incentives 
We expect from our prior research experience to be able to contact 85-95% of participants at each follow-up 
assessment.108,116,117  We will employ our previously successful procedures to maintain high follow-up 
rates.108,116-118 Additionally, participants will be paid $25 for 7-week follow up, $25 for the 13-week follow up, 
and (in Study 2) $25 for the 26-week follow up. These payments are not contingent upon PA level.  C.5. Data 
analysis: We will examine within-group changes from baseline in MVPA at 7 and 13 weeks. We will also 
tabulate scores on all treatment feasibility and acceptability measures, as well as baseline measures and 
putative mediators, to determine mean responses to these measures. 
Aim 2. We will focus on determining effect sizes for PPPA rather than strict statistical significance testing. At 
the same time, we are well aware of the dangers of relying exclusively on small-scale pilots to determine the 
promise of novel treatment approaches,119 as estimates from small samples tend to have large standard errors. 
Thus our hope is that we find a pattern of results that is supportive of the experimental treatment. Similar PPIs 
have shown medium to large effect sizes on depressive symptoms, positive affect, and happiness. Effect size 
estimates will include Cohen’s d (for unadjusted between-group comparisons) and f2 (for longitudinal 
multivariate models of treatment effect). For the purpose of estimating the effects of treatment on both MVPA 
and the putative mediators, we will fit a series of mixed effects regression models in which, for example, 
min/week of objectively measured MVPA at post treatment, and at 13 and 26 weeks will be simultaneously 
regressed on treatment group, baseline MVPA and variables not balanced by randomization. Models will allow 
for estimating both effects of treatment on MVPA post treatment, as well as maintenance of MVPA from 7 
weeks through 6m. A similar strategy will be used to estimate effect sizes with respect to treatment effects on 
the putative mediators.  We believe a sample size of 60 (40 intervention versus 20 control) should allow 
adequate examination of PPPA intervention effect sizes while staying within the scope of a developmental 
project.  We recognize that only medium to large effect sizes will be likely to attain statistical significance with 
an unbalanced sample of this size. Feasibility and acceptability: Between-group differences for continuous 
measures (number of sessions attended and client satisfaction scores at post-treatment) will be conducted 
using analysis of variance and chi-squared analyses for dichotomous variables (treatment retention).  We 
anticipate that treatment attendance and completion will either be equal or will be higher in the PPPA condition. 
Missing data. Although our follow-up rates in previous studies have exceeded 90%,108,116,117 some data will 
inevitably be missing. The proposed regression models use a likelihood-based approach to estimation and 
thus makes use of all available data (on the intent to treat sample) without directly imputing missing outcomes, 
to produce consistent estimates of the effects. However, we will compare the robustness of our findings using 
other statistical approaches for handling missing data, including propensity scores (in which we first model 
missingness as a function of observable data and then use the inverse predicted probability of drop-out as 
weights in the subsequent regression model).  Provided the data is missing at random (MAR) or that the 
probability of missingness can be fully explained by observable data, this approach produces asymptotically 
unbiased estimates.  To allow for the possibility that the MAR assumption may not hold, we will also use a 
second approach, pattern mixture models, in which the distribution of the outcome is assumed to follow a 
mixture of two distributions: one for those who complete follow up and another for those who do not.     
C.6. Timeline: Given our experience with similar research, we expect to finalize the PPPA manual prototype 
within the first month of the study period and be ready for recruitment and enrollment in the initial study cohort 
(Aim 1) by month 2. This will give us two months upon completion of the 6-week program (and 7- and 13-week 
follow-ups) to refine and revise the treatment protocol prior to enrollment for Study 2 at the start of month 6.  

 
Protection of Human Subjects 
1. Risks to the Subjects 
1.a. Human Subjects Involvement, Characteristics, and Design.  
Procedures for Aim 1: Intervention development and refinement (ORBIT phase 1) 
Overview. For Aim 1 (months 1-6), we will first develop a PPPA intervention prototype and corresponding 
treatment manual based on our existing PPT-S+ intervention and our extensive experience with PA promotion 
interventions. We will then test the preliminary 6-session PPPA intervention with 10 participants in a group 
format at two local branches of the Greater Providence YMCAs serving central (Kent County) and northern 
(Mount Hope) RI. The Research Interventionist (RI) will conduct the treatment sessions, which will be audio-
recorded and reviewed by Kahler, Bock (Co-Is), and Parks (Consultant) to provide ongoing feedback and 
suggestions. We will also solicit feedback from participants at the end of each in-person session. Adaptation of 
the intervention and treatment manual will be ongoing during this stage. 
Recruitment and screening. We will recruit 10 overweight or obese (BMI: 25-40) adults (>18y) through 
newspaper, internet, and radio advertisements. We will actively recruit minority women and men through 
targeted newspapers and radio stations. Participants must be sedentary or low-active, defined as < 60 
min/week of structured PA. Exclusion criteria will be history of coronary artery disease, stroke, uncontrolled 
hypertension or asthma, COPD, diabetes, osteoarthritis or orthopedic problems that limit PA,. Adults with BMI 
> 40 will be excluded given the increased risk of unsupervised PA in these populations.95 Only one participant 
per household will be permitted. Smokers will be eligible, with smoking status included as a covariate in a 
future RCT. Participants must be able to receive and respond to a text message at the time of screening.  
Orientation, baseline assessment, and YMCA membership. Individuals who are eligible on an initial phone 
screen will be asked to attend an orientation session at the local YMCA where the Research Assistant (RA) will 
provide more information about the study, and the opportunity to ask questions prior to signing consent. After 
orientation and consent, the RA will obtain height and weight, and observe participants use of YMCA aerobic 
exercise equipment to ensure adequate capacity for moderate intensity PA. Participants who remain eligible 
following baseline assessments will take with them an accelerometer to assess baseline frequency, duration, 
and intensity of moderate-to-vigorous PA (MVPA) over a one-week period. Orientations will be group-based 
and ongoing until 15 participants are eligible, thus allowing for a minimum of 10 participants in the PPPA 
intervention group. We expect to achieve this number within 2-3 weeks of recruitment. Participants will be 
provided a 3-month YMCA membership upon arrival at session 1 of the PPPA intervention.  
Primary treatment components. There will be 6 weekly one-hour PPPA treatment sessions consisting of 
core PA promotion content and positive psychology content. All participants will receive a treatment binder that 
contains information about each session. Core PA promotion content will be based on our previous PA 
promotion studies, and will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions 
based on age and resting heart rate, and instruction on how to gauge PA intensity, (c) goal-setting and self-
monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be 
instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines.96 PA content will 
be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will 
continue throughout the 6-week period. Positive psychology content: The exercises listed below begin in 
session 1 and will continue throughout the 6-week program, with PPPA homework completed via text-
messaging. Specific content for each session will be determined upon development of the intervention manual. 
PPPA model of PA promotion. In the PPPA model, success in maintaining regular PA is influenced by 
perceived physical and mental health benefits of PA, overcoming negative associations with PA, social and 
environmental factors, and personal factors such as commitment to PA, optimism, satisfaction with the past, 
and positive emotions. Examples of how PPPA will address each of these areas will be provided. Participants 
will be told that the combination of positive psychology strategies and regular PA can help develop and 
enhance pleasure, happiness, and meaning in life. Positive introductions. PPPA will begin by introducing the 
concept of signature strengths and how those can be important in adhering to a program of regular PA. 
Participants are provided feedback about their 5 signature strengths based on the Values in Actions Survey97 
and asked to share (via texting) how they demonstrated one of their strengths. Using signature strengths. 
Treatment providers highlight the role that signature strengths play in leading an engaged life and assign 
participants to find new ways to employ their signature strengths in their daily life. This treatment element has 
been empirically demonstrated to decrease negative affect and increase happiness.82 In PPPA, participants 
are also asked to consider how they can employ their signature character strengths to help them manage 

 
barriers to regular PA. Three good things. Participants are instructed to text about three good things that 
happened each day and their causes. This exercise has been shown to have rapid and lasting effects on 
reducing negative affect and increasing happiness82 and has been employed successfully via text 
messaging.98 Savoring. Treatment providers introduce the concept of savoring positive experiences. 
Participants are asked to savor at least two experiences each day for one week and text back their response to 
evening text prompts regarding homework completion. Active/constructive responding. Participants are 
instructed to listen carefully when people they care about report good events. They are instructed to stop and 
go out of their way to respond actively and constructively to these events and to keep a record of these 
experiences via nightly texting. Commitment and gratitude discussion. This exercise involves selecting an 
important support for PA, discussing with that person the reason one is grateful to them and the reasons they 
appreciate them, and asking for specific support for increasing and maintaining regular PA. 81,82 Maintenance 
of happiness. In the final session, participants discuss their experiences with PPPA and generate ways that 
they can modify these experiences in order to keep using them in their lives. They then choose one or two 
exercises to continue over the following months after treatment. Text messaging: Participants in PPPA will 
receive daily texts. Morning texts provide static messages relevant to a given PPPA exercise, while evening 
texts are interactive and ask for open-ended descriptions of what participants did to complete that day’s PPPA 
exercise, with a reminder sent after 1 hour if no response is received. These responses are tabulated for the 
counselor. Text messages specific to a PPPA exercise are initiated at the respective counseling session at 
which that PPPA exercise is introduced by texting a key word, e.g., ‘Savor’ to initiate the savoring texts. The 
PPPA exercise continues each day following the session until that exercise is replaced by a new exercise. At 
session 6, participants choose which PPPA exercises they want to continue and receive texts based on their 
choice for an additional 2 weeks. Participants are also given forms for completing exercises on paper if they 
prefer to write longer responses or won’t have cell phone access. Text messaging platform. We will build on 
the text-messaging platform developed by Co-I Bock and currently being used by Kahler and Bock.99 This 
program enables users to request additional support messages and uses two-way texting. This beta version 
has been successfully piloted, allowing us a quick time to start-up. 
Interventionist characteristics and training. The characteristics of the interventionist have implications for 
ultimate dissemination of the Positive Psychology for PA (PPPA) program should it show initial efficacy. A 
bachelor’s-level RI will conduct the treatment, with oversight from the investigative team. The RI will be similar 
in training and experience to the community-level staff that we expect would ultimately deliver the treatment in 
a future effectiveness trial and upon dissemination of the program. Treatment manuals will be developed to 
ensure consistent delivery of the PPPA and Standard PA promotion (SPA) interventions. The RI will practice 
the treatment protocol with other staff and students until it is delivered consistently. 
Treatment fidelity. A treatment fidelity checklist will be created for each session and completed at the end of 
each session by the RI. Additionally, all treatment sessions will be audio-recorded. Review of recordings along 
with a second completion of the checklist will be split among Williams, Kahler, and Parks, who will meet weekly 
with the RI to discuss any deviations from the treatment protocol. Although we do not expect deviations from 
the protocol, any such deviations will be addressed by the PI, with the RI retrained as needed. Weekly 
meetings will also be used to assess strengths and weaknesses of treatment components and suggest 
revisions to the protocol that will be implemented in the next phase of research (see below).  
Assessment timeline. Assessments will be conducted at baseline, ongoing during the 6-week PPPA program, 
at week 7 (one week after the final PPPA intervention session) and at week 13 (3-month follow-up). 
Measures. Demographics will be collected at baseline, including gender, ethnicity/race, education, 
marital/relationship status, income, and employment. PA outcomes: Total volume of MVPA (i.e., min of MVPA 
weighted by intensity) expressed in MET minutes will be determined by accelerometers (Actigraph wGT3x-BT) 
worn during one-week periods at baseline (prior to the start of treatment), immediate post-treatment, and 3-
month follow-up. Accelerometers will be worn on the right hip at the anterior axillary line using an elastic belt, 
consistent with standard practices.100  Instructions, including proper positioning, will be provided in person at 
baseline and again at the final, week 6, PPPA session. As our team has done in previous studies,101,102 we will 
use ActiLife software to determine PA intensity.103 However, we will also be collecting raw accelerometry 
output data thus allowing for consideration of alternative cutpoints (e.g.104-106) and/or data processing 
approaches (i.e., pattern recognition107) as the literature develops. MVPA will also be self-reported in diary form 
over the 7-day accelerometer period. This procedure is standard in the field, as it helps to verify accelerometry 
outputs and also accounts for MVPA that is not easily recorded by the accelerometer (e.g., stationary bicycle).  
Intervention feasibility and acceptability: We will record PPPA session attendance and responses to the 
evening text-messages as objective indices of feasibility and acceptability. Retention will be coded as a 

 
dichotomous variable with participants who complete the sixth and final treatment session characterized as 
treatment “completers” and those not attending the final session as “non-completers.”  Participants will 
complete a Treatment Strategies Questionnaire at sessions 2-6, which will assess frequency of use of specific 
PPPA strategies in the past week such as planning opportunities for PA and completing the 3 Good Things 
exercise.108 Responses to the questions will be used to inform the treatment feedback process. Satisfaction will 
also be assessed with the Client Satisfaction Questionnaire, an 8-item questionnaire that will be administered 
at the 7-week follow-up to assess participant satisfaction with provided services (CSQ-8).109 Positive 
psychology measures and putative mediators: The Values in Action Survey97 will be administered to all 
participants at baseline, and participants will receive feedback on their 5 “Signature Strengths” derived from 
this measure.81,82 The following putative mediators will be assessed at mid-treatment (session 3), post-
treatment (week 7), and 13-week follow-ups. Short-term changes in positive and negative affect will be 
assessed with the Positive and Negative Affect Scale.110 Trait optimism will be assessed with the well-validated 
revised Life Orientation Scale.111 Subjective happiness and subjective well-being will be assessed with the 4-
item Subjective Happiness Scale112 and the 5-item Satisfaction with Life Scale.113 Social support will be 
assessed at baseline and follow-ups using the 13-item Social Support for Exercise Scale.114 Finally, PA 
enjoyment will be assessed with the 18-item Physical Activity Enjoyment Scale.115 
Intervention refinement. During the initial PPPA intervention group, the intervention manual and materials will 
be refined based on an iterative treatment development process. After each of the sessions is completed, 
participants will complete brief questionnaires on perceived session utility and their use of PPPA strategies in 
the past week. Open-ended questions will also assess the utility and acceptability of the treatment sessions 
and exercises. Intervention refinement will also be based on investigators’ weekly reviews and discussion of 
the audio-recorded sessions. This will lead to a revised PPPA manual going into Phase 2. 
 
Additional procedures for Aim 2: Preliminary testing (ORBIT phase 2). 
Procedures for Aim 2 will be the same as Aim 1, with the following exceptions: 
Recruitment, enrollment, and randomization. We will recruit 60 participants who will be randomized at a 2:1 
ratio to PPPA treatment versus standard PA promotion (SPA) in order to focus resources on the PPPA 
program while still including a comparison for preliminary testing. We will run 4 groups of PPPA and 2 groups 
of SPA, with 10 participants per group. Urn randomization will be used to balance on sex and BMI.  
PPPA condition. The PPPA condition will follow the revised treatment manual and text messaging program, 
based on feedback from Aim 1, but will follow the basic themes and procedures noted above.  
SPA condition. The SPA condition will consist of the core PA promotion content (see above). To equate for 
session duration, additional information on health and wellness will be delivered by the staff, including topics 
such as skin care, alcohol use, and heart health. Text messages for the SPA condition will consist of 
reminders to engage in PA and other general motivational messages, thus controlling for total number of text 
messages. Because all of the PA-related content in the SPA condition will also be provided in the PPPA 
condition, this is essentially an additive design, with an equal contact control.  
Additional 6-month follow-up and 6-month YMCA membership. For both conditions, YMCA memberships 
will be extended for 6 months, and an additional assessment will take place at month 6 (wk 26). 
 
Participant retention, compliance, and incentives 
We expect from our prior research experience to be able to contact 85-95% of participants at each follow-up 
assessment.108,116,117  We will employ our previously successful procedures to maintain high follow-up 
rates.108,116-118 Additionally, participants will be paid $25 for 7-week follow up, $25 for the 13-week follow up, 
and (in Study 2) $25 for the 26-week follow up. These payments are not contingent upon PA level.   
1.b. Sources of Materials. 
Telephone interview: Screening for eligibility criteria at baseline. 
Questionnaires: Measuring demographics, and putative mediators of treatment effects at baseline, mid-
treatment, post-treatment, and 13 week (3 month) and (for Study 2) 26 week (6 month) follow-ups. 
Weekly questionnaires: Weekly questionnaires during the treatment period will assess frequency of use of 
specific PPPA strategies. 
Accelerometers and physical activity diaries: For assessment of PA behavior at baseline, post-treatment, and 
13 week (3 month) and (for Study 2) 26 week (6 month) follow-ups. 

 
Text messages: Participant responses to open-ended text messages regarding intervention exercises (i.e., 
homework) for both assessment and treatment planning purposes. 
1.c. Potential Risks. 
Complications associated with physical activity. The likelihood of serious orthopedic injury or cardiac event 
from moderate intensity PA (as targeted in the proposed study) is low. We have had no serious injuries 
reported from field-based PA in our previous PA studies (HL69866, HL64342, CA137211), although there have 
been occasional reports of minor sprains or strains. Nonetheless, participants may suffer broken bones 
resulting from falls or other physical activity-related injuries that prohibit them from walking for transportation or 
engaging in daily activities. 
Loss of Confidentiality. The likelihood of this is low and it has not occurred in our prior studies. 
2. Protection against Risks. 
Informed Consent: Potential participants will be recruited primarily through newspaper, radio, website, and 
email advertisements. Individuals who are eligible on the phone screen will be asked to attend an orientation 
session where they will be given more information about the study, and the opportunity to ask questions prior 
to signing consent. Those who agree to the procedures will provide written consent to participate. The study 
GRA will seek informed consent.  
Complications associated with physical activity:  Subjects will be screened for orthopedic problems particularly 
gait disturbances prior to enrolling.  Subjects will also have demonstrated competence on YMCA aerobic 
exercise equipment as a condition of enrollment in the study (see above). Although we do not expect it will be 
necessary, both Brown research staff and YMCA staff have the capacity and training to deal with cardiac 
emergencies, with automated external defibrillators (AEDs) immediately available in each building.  
Loss of Confidentiality: Confidentiality will be maintained by numerically coding all hard-copy data, by 
disguising identifying information, and by keeping all data in locked file drawers.  All information obtained from 
participants will be accessible only to research staff. Data obtained from the text messaging protocol will be 
uploaded onto a secure server, with data coded by participant ID only. Previously entered data will be deleted 
following transmission to the secure server. 
3. Potential Benefits of the Proposed Research to Human Subjects and Others. 
The risks to participants in this study are judged to be minor (potential for sprains and strains) or of low 
likelihood (cardiac event, loss of confidentiality). However, participants will have the potential for great benefit 
in adopting a program of regular physical activity, which has been shown to enhance weight regulation and 
decrease risk of multiple cancers and all-cause mortality. 
4. Importance of the Knowledge to be Gained. 
The risks to participants in this study are judged to be minor or of low likelihood.  The anticipated benefits are 
great, insofar as the results will be used to further understanding of the factors related to PA adoption and 
maintenance among previously inactive adults, which is a critical public health problem. 
 
 
 

 
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