Empowering the Management of Pain-Obesity-Weight Through Enhanced Reward
Phase: NA
Conditions: Low Back Pain
Sponsor: University of Florida

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Cover Page for ClinicalTrials.gov 
 
Document: 
Protocol 
 
 
Official Study Title: 
Empowering the Management of Pain-Obesity-Weight through Enhanced 
Reward 
 
 
NCT Number: 
NCT04851587 
 
 
Document Date: 
07/11/2022 
 
 

2 
 
Protocol 
 
1. Project/Grant Title: Empowering the Management of Pain-Obesity-Weight through Enhanced 
Reward (EMPOWER) 
 
2. Investigators: 
Emily J. Bartley, Ph.D. (PI) 
   
Megan A. McVay, Ph.D. (PI) 
 
 
  
Stephen Anton, Ph.D. (Co-I) 
 
 
 
Jeewon Chong, Ph.D. (Co-I) 
 
 
 
Shawn McGargill, M.D. (Co-I) 
 
 
  
 
3. Abstract: Chronic low back pain (cLBP) is the leading cause of disability worldwide and is one of 
the top reasons for seeking healthcare. High-impact low back pain is particularly problematic, 
defined as chronic pain accompanied by significant restrictions in work, social, and/or self-care 
activities for six months or more. High-impact pain is associated with greater pain-related disability, 
opioid use, and healthcare costs compared to pain of lower impact. Thus, efforts to reduce chronic 
pain impact have become a public health initiative. Low back pain and overweight/obesity are 
highly comorbid; overweight and obese individuals are up to 43% more likely to have cLBP 
compared to normal weight individuals. Together, the additive effects of overweight/obesity and 
chronic pain may play a larger role in increasing the risk for other adverse health-related 
comorbidities. Therefore, the aim of this exploratory study is to examine the feasibility and 
acceptability of an integrated pain and weight management intervention (EMPOWER) for middle-
aged and older adults with moderate-to-high impact low back ,knee, and/or hip pain by addressing 
mechanisms of environmental reward and positive affect. Forty adults (ages 45-80 years) with 
comorbid overweight/obesity (BMI≥25 kg/m2) and moderate-to-high impact cLBP will be assigned 
to an 8-month intervention, whereby they will receive a group- and telephone-based program 
featuring integrated behavioral weight loss treatment and cognitive-behavioral pain coping 
therapy, including systematic pleasant activity scheduling and values-clarification techniques. 
Assessments will be conducted at baseline and at the 4- and 8-month time points. The proposed 
research will be a step toward the development of therapeutic modalities aimed at improving pain 
and weight management in adults with comorbid cLBP and overweight/obesity, and will provide 
essential information to guide a larger, randomized-controlled trial of the EMPOWER intervention. 
 
4. Background: Chronic pain is prevalent and burdensome in older adults. More than 1 in 4 adults 
ages 45 and older have chronic pain (compared to 1 in 7 aged 25-44).11 A particularly common 
age-related pain condition is chronic low back pain (cLBP). cLBP affects an estimated 13% of 
Americans, with adults in their 50s and 60s having twice the odds of experiencing cLBP as those 
in their 20s.51 cLBP promotes decrements in mental health, physical mobility, social functioning, 
and activities of independent living.23 cLBP is the leading cause of disability in the US and globally8, 
22, 40 and contributes substantially to healthcare utilization and costs.39  
 
In 2016, the US Department of Health and Human Services released the National Pain Strategy 
in an effort to reduce the burden of chronic pain in the US.9 A key recommendation of this strategy 
was to address high-impact chronic pain (HICP), defined as significant pain-related restrictions in 
work, social, and self-care activities. Pain impact has also been an important focus of the NIH Task 
Force on Research Standards for low back pain, which recommended that cLBP be stratified 
according to the extent of pain impact.13 It is estimated that approximately 20 million Americans 
are affected by HICP,11 with greater impact associated with increased healthcare utilization and 
opioid usage,27 as well as greater health and psychological comorbidities.47 Further, the 
prevalence of HICP increases with advancing age from 4.4% among 25-44 year old’s to 12.0% 
and 10.7% among adults ages 45-64 and 65-84, respectively.11 Targeting pain impact among 
adults 45 and older is thus an important public health priority.  

3 
 
 
Defined as a body mass index (BMI) ≥30 kg/m2, obesity affects approximately 40% of American 
adults,24 with an additional 32% being overweight (BMI 25.0-29.9).42 Excess weight is associated 
with negative health and psychological outcomes, including cardiovascular and metabolic 
diseases, lower quality of life, and mortality.21, 32, 34, 45 Individuals who are overweight or obese are 
up to 43% more likely to have cLBP compared to adults with a BMI≤25kg/m.50 Thus, obesity or 
overweight is present in the vast majority of US adults with cLBP. The comorbidity of excess weight 
places individuals with chronic pain at greater risk for disability, depression, and chronic opioid 
consumption,15, 43, 55 as well as increasing the risk for cardiovascular disease, sleep disorders, 
depression, cognitive impairment, and mortality.6, 20, 43, 46, 53, 62 
 
Existing evidence indicates that the relationship between pain and weight is bidirectional and 
multifaceted.30, 43 We have developed a conceptual model explicating key pathways by which pain 
and weight influence each other, drawing from previous literature, our own recent work in this 
area3, 4 and existing theory (Figure 
1).10, 17, 25, 33, 60  This model shows that 
pain 
(due 
to 
injury 
or 
other 
precipitants) results in a sequelae of 
adverse behavioral and affective 
consequences. 
Two 
of 
these 
consequences—reward 
deprivation 
and decreased positive affect—may 
be of particular importance for the 
pain-weight 
relationship. 
Reward 
deprivation occurs when chronic pain 
alters the reward value of activities, 
thereby leading to reduced enjoyment 
in and withdrawal from activities that offer potential pleasure, meaning, and value.33, 38 
Overgeneralized fear of pain can also increase withdrawal and loss of reward, consistent with the 
“fear avoidance model” of pain.10, 60 Both due to this loss of reward and directly to the pain itself, 
individuals also experience reductions in positive affect.7  
 
In turn, reward deprivation and decreased positive affect can increase dietary intake and decrease 
physical activity. In particular, when sources of non-food reward are limited, high calorie food may 
have greater reinforcing value, resulting in greater caloric intake. This is predicted by behavior 
choice theory, which posits that engagement with a reinforcer, such as food, is likely to be greater 
in the absence of alternative reinforcers.17 Low levels of positive affect may also lead to reduced 
physical activity.49 The collective result of increased food intake and diminished physical activity is 
weight gain, which in turn worsens pain and pain impact (via joint loading, biochemical mediators, 
inflammation, etc.),43, 59, 65 and increased pain and pain impact in turn can contribute to further 
weight gain. Additionally, excess weight can facilitate loss of environmental reward via weight-
related limitations on activities, further perpetuating pain impact and weight gain.12, 35, 64  
 
To increase environmental reward and engagement in pleasant activities, we will adapt 
approaches that have successfully addressed those targets in other populations. From Behavioral 
Activation for depression,7, 33, 35 we will adapt pleasant activity planning techniques, which include 
activity monitoring, assigning increasingly more difficult activities that include the potential for 
increased pleasure or mastery, and problem solving roadblocks to activity engagement.29 These 
techniques have demonstrated effects on engagement in pleasant activities, environmental 
reward, and positive affect.37, 48, 57 From Acceptance and Commitment Therapy (ACT; an evidence-
based psychotherapy) we will adapt values clarification therapeutic techniques, which involves 

4 
 
identifying personal value systems that patients find meaningful and encouraging the engagement 
in activities that are in accordance with core values. We anticipate that these techniques will 
increase involvement in pleasant activities, which will enhance environmental reward and positive 
affect; in the context of weight loss treatment, this increased reward and positive affect will result 
in reductions in food intake and increased physical activity.  
 
5. Hypotheses and Specific Aims: The central objective of research is to examine the feasibility 
and acceptability of an 8-month (4-month if only 8 core intervention sessions are completed) 
single-arm behavioral intervention (i.e., EMPOWER) among overweight/obese middle-aged and 
older adults with moderate-to-high impact musculoskeletal pain. Intervention content will focus on 
standard behavioral weight loss treatment and standard cognitive-behavioral pain coping therapy, 
which will be delivered in a fully integrated manner to take advantage of overlapping techniques 
used in each (e.g., addressing negative cognitions related to weight and pain in a single session).  
 
Specific Aim 1: Evaluate the acceptability of the EMPOWER intervention, as indicated by 
treatment engagement and participant reported treatment credibility and satisfaction, and potential 
for treatment efficacy. 
 
Specific Aim 2: Determine trial feasibility, including the ability to meet pre-specified recruitment 
and retention metrics. 
 
6. Research Plan:  
 
Recruitment  
 
Institutional Data Repository (IDR) Invitational Messages. We will have an IDR search 
performed for patients who (1) have had appointments in the UF health care system over the last 
month, (2) have agreed to be contacted for future research (“Consent2share” patients), (3) have 
a diagnosis consistent with musculoskeletal pain, (4) have a BMI from the past 2 years over 24 
kg/m2, and (5) are age 45-80. We will obtain a list of patients’ names, email addresses, and mailing 
addresses. We will also obtain patient sex and race to inform our goals of recruiting a diverse 
sample. We will send these patients one mailed letter and one email informing them of the study 
and invite them to share their contact information through a REDCap link provided. In addition to 
the letter from the study team, the mailing will include a study flyer and a return postcard that 
patients can mail to study investigators if interested in participation. The email and letter will include 
a link to a video to learn more about the study.  Patients who share their contact information will 
then be called by study staff to complete the phone screening.  
 
In addition, we will also send an email and letter to patients who have had an appointment in the 
prior month with a UF health care provider who has agreed to allow us to send letters to his/her 
patients. We will obtain the list of patients by conducting an IDR pull to identify patients with 
appointments in the prior month who have a diagnosis consistent with musculoskeletal pain, a 
BMI from the past 2 years over 24 kg/m2, and are age 45-80. IDR will provide patients' names, 
provider name, patient email address, and mailing address so we can send them the letter from 
their provider, as well as their race and gender so that we can over-recruit minority individuals to 
ensure representativeness of our sample. We will send a signed letter from the provider from the 
study email address. We will also send a study flyer and a return postcard that patients can mail 
to study investigators if interested in participation. 
 
 

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Provider Referral. All providers in the UF Comprehensive Spine Clinic (CSC) will be informed of 
the study via email and via discussion with study Co-I and CSC physician, Dr. Shawn McGargill. 
When Dr. McGargill or other providers identify a patient who may be eligible, they will have two 
options to refer the patient to the study. First, they can send a message through EPIC to our study 
coordinator. Second, they can fill out a contact postcard that will be available in the clinic, then 
place that contact card in a box provided (that will only have a slot to enter cards, for security 
purposes). These cards will have study contact information, and providers will also be encouraged 
to give cards to patients to take home and reach out directly, if desired. Study staff will check for 
new contact cards weekly.  
 
In-clinic recruitment. Research staff will approach patients before or after their clinic visit in the 
clinic room to introduce the study to them and determine if they are interested in joining the study. 
Patients will only be approached after their medical provider has asked them if they would like to 
hear about the study and then respond affirmatively. Participants will be given a short introduction 
to the study and if they are interested they will be asked to provide their contact information.  
 
Other recruitment. Participants will also be recruited from clinic and community flyers, newspaper 
advertisement, UF HealthStreet, and the UF Pain Research and Intervention Center of Excellence 
(PRICE), Institute on Aging Pepper Center, and the University of Florida Jacksonville Aging 
Studies Center Research Participant Recruitment registries.  
 
Screening. All potential participants will undergo an initial phone screening interview, via 
telephone or in person. We have requested a waiver of written informed consent to retain this 
information; we will provide verbal consent information and allow participants the chance to ask 
questions. The initial screening will include questions regarding pain, age, weight, and additional 
health history information to ensure that no exclusion criteria are present. For participants not 
affiliated with the University of Florida Health Care system, we will be asking a series of questions 
to assess any instability of the spine. If instability is determined, the participant must contact their 
own physician for written permission to partake in the study. If still eligible, participants will be 
scheduled for an individual in-person baseline assessment during which informed consent will be 
reviewed, medical and demographic history will be obtained to ensure eligibility, questionnaires 
will be administered, and a physical performance battery will be conducted to examine lower 
extremity function.  At the completion of the baseline assessment, eligible participants will be 
scheduled for the intervention program (90 min/session). 
 
Participants. A total of 40 middle-aged and older adults with moderate-to-high impact chronic 
musculoskeletal pain (e.g., lower back, knee, hip) and overweight/obesity (BMI≥25 kg/m2) will be 
targeted. Assuming a 20% attrition rate, an additional 8 subjects will be enrolled, leaving a total of 
48 participants to be recruited for study intervention procedures (we anticipate recruiting a total of 
60 people to account for screen failures). Participants will still be included if they report the 
presence of medical pain comorbidities; however, subjects must identify musculoskeletal pain as 
their primary pain condition. 
 
Inclusion Criteria 
• 
45-80 years of age 
• 
Have a BMI≥25kg/m2 
• 
Endorse pain in the lower back region (i.e., space between the lower posterior margin of the 
rib cage and the horizontal gluteal fold), knees, or hips 
• 
Pain must occur on at least 50% of the days in the previous six months  
• 
Pain must be rated, at minimum, of moderate intensity (rating of 3 on a numeric rating scale 
ranging from 0-10)   

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• 
Pain impact must be rated as moderate to severe (as determined from the RTF Impact 
Stratification Score).  
• 
Study physician, Shawn McGargill, MD, reviews medical record and declares patient medically 
appropriate for exercise protocol. 
 
Exclusion Criteria 
• 
Current participation in another psychological treatment or structured weight loss program 
• 
Severe psychiatric illness not adequately controlled by medication or other conditions 
anticipated to impair intervention engagement (e.g., substance abuse/dependence) 
• 
Presence of chronic, malignant pain (e.g., cancer)  
• 
Significant cognitive impairment (<26) on the Montreal Cognitive Assessment (MoCA)41 
• 
Inability to read and write English 
• 
Currently undergoing radiation or chemotherapy for cancer 
• 
Self-reported cardiac event in the past 6 months or self-reported Heart Failure (CHF) 
• 
Currently pregnant or breastfeeding, or planning to become pregnant during the study time 
period 
• 
Back, knee, or hip surgery within the past six months of study entry (or planned surgical 
interventions for pain during forecasted study participation) 
• 
If currently taking prescription analgesic or psychotropic medication, must be stabilized on 
these treatments for >4 weeks prior to the baseline assessment  
• 
Blood pressure higher than 180/100 mm Hg at baseline assessment 
• 
Has had bariatric surgery in the past year or is planning to have it in the next year 
• 
If participant reports the presence of systemic inflammatory disease (e.g., rheumatoid 
arthritis), the study physician will be consulted to determine eligibility 
 
 
All participants attending assessments will be required to wear Personal Protective Equipment 
(PPE) during in-person visits. PPE (masks) will be provided by study staff upon participant arrival 
or participants may bring their own. In addition, all participants who attend in-person group 
sessions are required to show proof of COVID-19 vaccination. If proof of COVID-19 vaccination is 
unavailable, participants will still be eligible to participate through PHI Zoom group sessions. If 
intervention sessions are conducted through PHI Zoom, study staff will ensure participants have 
access to Zoom as well as a stable internet connection. Study staff will also ask participants if they 
have access to a space that will provide confidentiality (e.g., not conducting Zoom call where other 
people may overhear, inform other household members about confidentiality expectations, ensure 
no identifying information is visible through camera). Zoom tutorials will be provided during the 
Baseline Session.  
 
Participants will be compensated $30 for attending assessment sessions and $15 per group 
intervention session. This is comparable to subject remuneration for studies of similar time 
commitment and invasiveness. Participants will receive partial payment if they do not complete 
the entire study. For participants traveling more than 25 miles each way to complete in-session 
study visits, we will reimburse some travel expenses at up to the federal mileage rate (cap of 
$200). Payments for participation will occur after completion of each study session and will be 
handled through the University of Florida’s Human Subject Payment Program.  
 
Intervention Procedure. The intervention includes 8 core in-person group sessions and 8 optional 
in-person group sessions (1.5 hours each) targeting standard weight loss and pain treatment 
content and eight individual phone calls (30 minutes each) focusing primarily on increasing 
environmental reward and positive affect. Due to COVID-19, intervention sessions may be 
delivered online through PHI Zoom. Group sessions will be delivered every-other week and phone 

7 
 
calls will occur every-other week (during weeks with no group). Sessions will be administered by 
a study interventionist with bachelors- or masters-level training and certification in health education 
or a related field (e.g., Certified Health Education Specialist), and materials will be developed to 
be appropriate for delivery by this level of training, given the potential for greater availability of 
these types of health professionals. To standardize the application of the intervention and ensure 
treatment fidelity, the intervention will be manualized and will include interventionist and client 
workbooks written at the 6th grade reading level. 
 
The standard weight management intervention components are closely adapted from the Diabetes 
Prevention Program14 protocol—considered a gold standard weight loss intervention—while the 
pain coping content is adapted from empirically-supported pain management protocols.26, 44, 58 
(Table 1). Consistent with standard behavioral weight loss treatments, participants will be assigned 
a goal of losing 5-7% of baseline weight over the 8-month intervention (with a daily 500 kcal deficit 
goal) and given recommendations for dietary intake based on the American Heart Association 
guidelines (e.g., emphasis on whole grains, limitation of saturated fat). They will be asked to 
engage in daily monitoring of their food and drink intake, either via a free commercial app of their 
choosing or paper and pen. Physical activity goal setting and monitoring will be integrated in the 
pleasant activity planning portion of the intervention. To increase non-food environmental reward 
and positive affect, the first two group sessions will include psychoeducational content addressing 
the importance of pleasant activities as a way of disrupting the chronic pain and weight cycle, and 
values clarification techniques to motivate engagement in pleasant activities. At these sessions, 
participants will also review a list of commonly enjoyed pleasant activities and brainstorm 
additional activities to include on the list.  
 
All phone sessions will focus on pleasant activity scheduling and values clarification, including 
setting new activity goals, evaluating prior goal progress, and problem-solving challenges to 
meeting goals. Interventionists will guide participants from setting easily achievable to more 
challenging goals as treatment progresses. In order to encourage exposure to a variety of 
potentially reinforcing activities and to increase overall physical activity level, participants will be 
asked to select at least one goal from each of three categories: a social activity, a cognitively 
enriching activity, and an activity that involves at least a moderate level of physical exertion. At the 
end of each phone call, interventionists will record participant goals. At the beginning of each 
phone and group session, participants will be given a list of their prior goals and will respond to 
standardized questions regarding which specific goals they achieved since the prior session, how 
much time they spent on these activities, and how much pleasure and value they received from 
them.  
 
Study Measures. As shown in Table 2, several questionnaires will be administered to assess 
feasibility and acceptability, pain-related symptoms, and psychological functioning. 
 
Anthropometric and Medical History. At baseline, blood pressure will be measured, height will 
be assessed to the nearest cm using a wall stadiometer, and participants will complete a thorough 
Medical History Questionnaire assessing the reported duration of musculoskeletal pain, current 
and past treatments for musculoskeletal pain, comorbid conditions, and current medication use. 
At baseline and at the 4- and 8-month in-person visits, body weight will be measured to the nearest 
0.1 kg using a digital scale with participants in light clothing and shoes removed. Health status will 
be monitored at each group session. 
 
Cognitive Testing. At baseline, the Montreal Cognitive Assessment (MoCA),41 a widely used 
screening assessment for detecting cognitive impairment, will be adminstered. It was validated in 
the setting of mild cognitive impairment and has subsequently been adopted in numerous other 
settings clinically. Participants with scores <26 (or under PI discretion) will be excluded from 

8 
 
participation as this could interfere with completion of the study intervention. The 
alternative/equivalent version of the MoCA (Version 7.2) will be used to decrease possible learning 
effects when the MoCA (Version 7.1) has been administered within the past 3 months of study 
participation. This will serve as a safeguard for test-retest effects for participants who may have 
recently participated in studies requiring the administration of this instrument. 
 
Measures of Treatment Acceptability. We will obtain acceptability data at each session and at 
study assessment points. After each group/phone session, the study interventionist and 
participants will complete treatment engagement questions adapted for the current study to assess 
participants’ effort exerted during group activities/phone calls, completion of homework, and 
engagement in discussions. They will also answer open-ended questions on their satisfaction with 
and usefulness of the session components. At the baseline assessment, participants will complete 
an adapted measure of treatment credibility and expectancy5 to assess the perceived credibility of 
treatment and expectation for improvement. At 4 and 8 months (if applicable), the 8-item Client 
Satisfaction Questionnaire (CSQ-8)2 will be administered to measure general treatment 
satisfaction, perceived quality of treatment, and willingness to recommend the treatment. 
Additionally, at 4 and 8 months (if applicable), participants will complete Likert ratings and answer 
open-ended questions on their satisfaction with the intervention components (e.g., values 
clarification exercises) and recommendations for intervention improvement. Responses to all 
acceptability measures will be used to refine the protocol across cohorts. 
 
Qualitative Interviews: To obtain more in-depth perspectives, study PIs will conduct qualitative 
interviews with a portion of participants who have completed the intervention. Interviews will either 
occur in person or on HIPAA-compliant Zoom with only audio activated (no video). From our total 
sample we will purposefully sample for participants who achieved a reduction in pain impact and 
weight and from those who did not see a reduction in pain impact and/or weight. We will interview 
a minimum of 12 participants but will continue interviews if we do not reach thematic saturation. 
The structured interview will include questions about participant perceptions of the intervention 
modality and structure, group and individual session content, and barriers to engagement in 
pleasant activities. These will be conducted around the Month 4 timepoint if participants complete 
only the 8 core intervention sessions, and will occur aroung the Month 8 timepoint if all 16 
intervention sessions are completed. Directed content analysis will be used to analyze the data.28  
 
Treatment Outcome and Mediator Measures: We will conduct study assessments at baseline 
and at the 4- (mid-intervention) and 8-month time-point (end of intervention. Participants who 
attend only the core 8 sessions will be asked to attend the 8-month assessment to be able to 
compare effects across those who do and do not attend optional sessions, and to examine 
durability of effects. These assessments serve two purposes: (1) evaluate our ability to obtain 
outcome measures in this population (and to adjust retention strategies over the course of the 
pilot, if needed) and (2) evaluate the potential of the intervention to produce a meaningful effect of 
the intervention on pain impact. Pain Impact will be assessed by a combination of 9-items from 
the PROMIS Short Form assessing pain intensity, pain interference with normal activities, and 
physical function (see below PROMIS measures for a description). Impact stratification scores 
range from 8 (mild impact) to 50 (severe impact).13 Several measures from the PROMIS–Short 
Form1, 13 will be administered to assess self-reported pain intensity, pain interference, depression, 
and physical function. The Short Physical Performance Battery (SPPB) consists of three measures 
of lower-extremity function: standing balance, 4-meter walking speed, and ability to rise from a 
chair. These measures have been standardized and are widely used in older populations as 
measures of lower extremity function. The SPPB will be completed at Month 0 and Month 4.  The 
Graded Chronic Pain Scale is a 7-item scale that evaluates global pain severity and pain-related 
interference over the past 6 months.. The GCPS yields a “Characteristic Pain Intensity” score and 
an overall “Disability” score. The Community Health Activities Model Program for Seniors 

9 
 
(CHAMPS)54 
assesses 
weekly 
frequency 
and 
duration of  a variety of 
lifestyle physical activities for 
seniors. Food intake will be 
assessed 
via 
the 
NCI 
Automated 
Self-
Administered 
24-hour 
Dietary Assessment Tool 
(ASA24).56 Over a one-week 
period at baseline and 4 
months, 
participants 
will 
complete ASA food recalls on 
three days (2 weekdays and 1 
weekend), with the specific 
days 
not 
known 
to 
participants in advance. To 
assess 
Pleasant 
Activity 
Engagement, 
participants 
will complete standardized self-report questions at each intervention phone call on their weekly 
engagement in pleasant activities, duration of engagement (in minutes), and the level of enjoyment 
for each activity (completed on a numerical rating scale [NRS] ranging from 0 “none” to 100 
“extremely”). The Meaningful Activity Participation Assessment (MAPA)16 is a 28-item 
checklist reflecting common activities that are meaningful to older adults. Items are rated both for 
how much time is spent and how meaningful the activities are perceived to be. The Positive and 
Negative Affect Schedule (PANAS)63 is a 20-item scale assessing positive affect (PA) and 
negative affect (NA). The Food Pain Coping Questionnaire is a 2-item scale assessing food use 
as a coping mechanism for chronic pain. The World Health Organization Quality of Life–Brief 
(WHOQol-Bref) 52 scale consists of 26 items assessing quality of life over the past week in four 
domains: physical health, psychological health, social relationships, and environment. 
 
To measure Ecological Momentary Assessment (EMA) of Pain, Mood, and Physical Activity, 
the smartwatch app ROAMM will be installed on commercially-purchased smartwatches (i.e., 
Apple Watch) to obtain real-time measures of pain intensity, mood, and physical activity.36 
Participants will be asked to wear a smartwatch for 7 days  at baseline and 7 days at  the 4-month 
time-point, during which they will receive three daily prompts (morning, afternoon, evening) to 
complete measures of current pain intensity (0 to 10 NRS ranging from none to worst possible) 
and mood (0 to 10 NRS ranging from extremely negative to extremely positive mood). Participants 
will also complete nightly prompts as to whether they engaged in a 1) social activity, 2) mind-
enriching activity, and 3) exercise (yes or no response). Assessment ratings will be entered by 
rotating a bezel on the watch interface. Continuous accelerometry data will be collected as a 
measurement of physical activity (average minutes spent per day; collected at 15 Hz).  
 
Statistical Methods. To account for variability and imprecision in sample estimates that often 
accompany smaller pilot studies, we will create 95% confidence intervals (CIs) around all feasibility 
and acceptability outcomes and consider the data supportive of progression to a full trial if these 
confidence intervals include our metric for success.  
 
Specific Aim 1: Evaluate the acceptability of the EMPOWER intervention, as indicated by treatment 
engagement and participant reported treatment credibility and satisfaction, and potential for 
treatment efficacy. We will examine treatment engagement at each session and will measure 

10 
 
several aspects of global acceptability at baseline and at the 4- (mid-intervention) and 8-month 
(end of intervention) assessment period.  
 
Session-level Engagement. Treatment engagement will assess participants’ effort exerted during 
group activities/phone calls (using a 9-point Likert rating scale), completion of homework (yes/no), 
and engagement in group and individual discussions (using a 9-point Likert rating scale). 
Responses will be examined after sessions and after all four cohorts are complete (considering 
the mean and range of Likert ratings for each questionnaire item). We will also develop a 95% CI 
around the Likert ratings and examine if our metric for success falls within that interval (i.e., ≥6 on 
a 9-point Likert scale).  
 
Global Treatment Engagement. The mean portion of group and phone sessions attended will be 
examined across the entire sample, as well as trends in the portion of sessions attended across 
the four cohorts. We will determine if our metric for success falls within a 95% CI around our 
identified threshold for success. The percentage of participants who complete ≥80% of group and 
phone sessions combined will also be measured, as well as the portion who complete ≥70% of 
group sessions and ≥70% of phone sessions (considered separately).  
 
Global Treatment Satisfaction and Credibility. On the Client Satisfaction Questionnaire-8 (CSQ-8) 
and on the adapted Treatment Credibility and Expectancy Scale, we will present the mean (sd) 
and range as well as develop a 95% CI around questionnaire ratings to examine in relation to our 
metric for success (i.e., treatment satisfaction: ≥3 on a 4-point Likert scale; treatment credibility: 
≥7 on a 11-point Likert scale).   
 
Potential for Efficacy. To evaluate the potential for intervention efficacy on pain impact, weight, 
and key putative mediators, we will determine the mean, standard deviation, and range associated 
with treatment-related changes in these outcomes. We will also develop 95% CIs around the 
observed mean and examine whether a pre-determined minimal change score is within these CIs. 
For pain impact, the minimally important change score will be 30% of the baseline score as this 
number has been previously defined as a clinically meaningful reduction in pain.19 For weight, the 
minimal important change score is a 5% reduction in body weight, given that this value is well-
established to result in clinically important changes in health parameters.31  
 
Specific Aim 2: Determine trial feasibility, including the ability to meet pre-specified recruitment 
and retention metrics.  
 
Recruitment. We will present the rate of recruitment in units of participants/week (only including 
weeks of active recruitment). We will also report the portion of participants contacted and 
screened, including those who were enrolled and reasons for ineligibility. We will develop 95% CIs 
around the recruitment rate and determine if our metric for success is within that confidence 
interval (i.e., ≥2.5 participants enrolled per week during active recruitment; ≥90% of those who 
enroll commence treatment).  
 
Retention. We will present the portion of participants who attend the 4- and 8-month assessment 
sessions, by cohort and the total sample. We will determine if our metric for successful retention 
(≥80% who enroll complete the 8-month assessment, among the final two cohorts) falls within a 
95% CI of our obtained retention.  
 
Data and Safety Monitoring. The proposed trial presents minimal risk to participants. The study 
PIs, Drs. Bartley and McVay, while be responsible for data and safety monitoring with oversight 
from an external Safety Officer, David Edelman, MD (Duke University). Dr. Edelman will review 
the study protocol, Manual of Procedures, and Data and Safety Monitoring Plan prior to enrolling 

11 
 
patients, and will be provided data on certain safety issues that arise during the study and given a 
summary of all adverse events and at a meeting one year after the start of enrollment. At each in-
person group session and assessment period, we will inquire whether any adverse events or 
unanticipated problems occurred. Additionally, if participants disclose adverse events or 
unanticipated problems between group sessions (e.g., during phone sessions) they will be 
systematically recorded on the “Adverse Event and Unanticipated Problems form” developed by 
the University of Florida’s Institutional Review Board. All serious and unexpected adverse events 
will be reported to the University of Florida IRB (within 5 working days), the Safety Officer, and the 
study’s sponsor. Other types of adverse events will be monitored and reported to the University of 
Florida IRB in the study’s annual progress review. Any adverse events or unanticipated problems 
reported will be followed until resolution, stabilization, or until it is determined that the study 
participation is not the cause. The study investigators will review reported adverse events every 
three months to minimize the risk to study subjects. The principal investigators, Drs. Bartley and 
McVay, will be responsible for the timely execution of this plan. 
 
Electronic data from the smartwatches will be stored on password protected, secure and encrypted 
Amazon AWS servers according to UF policy. The collected data includes raw accelerometer data 
(acceleration values in three x, y, and z direction and timestamp), heart rate (per minute), GPS 
readings (latitude, longitude), mood, pain, activity type, and timestamps. The smartwatch does not 
collect restricted data – it does not collect health information and it is not connected to identifiable 
information. Therefore, the data collected on the device is exempt from encryption standards set 
forth by the UF Information Security Policies and Standards. All devices will be clearly marked as 
not for use with restricted data and will have a durable physical or electronic label with contact 
information sufficient to facilitate an expedient return to study staff if a lost device is found. Each 
device is coded with a number that is assigned to a participant. This assignment document is 
housed under a secure local server per UF Information Technology Security Charter and managed 
by the study staff. Data from the smart-watch is temporarily stored, remotely sent to secure servers 
and then erased from the local disc. Therefore, data on the smartwatch is “not” stored locally — it 
is permanently erased after uploading it to the Amazon AWS server. Data sent to the server is 
protected in locked and secure lab with strong password protection and full disk encryption. 
 
Confidentiality. All trained personnel assisting with the study will be instructed on the importance 
of protecting participants’ confidentiality and will have successfully completed the required 
education on protection of human research participants. All paper and computer records will be 
identified only by subject number rather than by name. All study records will be stored in locked 
file cabinets and will only be available to the PI or other project staff. Computer data files (without 
subject identifiers) will be stored on computer servers with secure passwords and electronic 
storage devices will be encrypted. All study records will be stored in locked file cabinets and will 
only be available to the PI or other project staff. Study staff will be instructed to not record any 
information (e.g., responses to pain criteria) obtained during the phone screen.  
 
Each intervention session will be audio-recorded for the evaluation of therapist adherence to the 
protocol, and a random selection of 25% of all sessions conducted will be reviewed by the study 
PIs. Given that Zoom group sessions will be video-recorded (in order to obtain the audio 
recording), all video recordings will be destroyed immediately after each session. Additionally, we 
will conduct individual interviews with participants at the end of the study to evaluate their 
perceptions of the program. No identifying information will be transcribed as the purpose of this 
digital recording is to assess treatment integrity. Once the group session audio recordings are 
reviewed and adherence is discussed with the study interventionist, the recordings will be 
destroyed. For the individual interviews, we will transcribe all recordings and destroy the audio 
after transcription. Prior to destruction, the recordings will be kept in a locked filing cabinet in the 
laboratory of the PIs. Data obtained during audio-recorded qualitative interviews with patients may 

12 
 
be used in future publications but will not be linked with names or identifying information. The audio 
file will be downloaded from Zoom (or via audio recorder if conducted in person), saved on a 
password protected computer in our University office, and transcribed for responses to the 
questions. No names will be included on the typed files. If any personal information comes up 
during the interview, the information will be redacted from the transcript. Quotes from the interview 
may be used in future publications but will not be linked with names or identifying information. All 
audio recordings will be deleted from the network drive where it will be stored, with assistance 
from the IT department once they have been de-identified and transcribed, no later than 12 months 
after they are recorded. 
 
7. Possible Discomforts and Risks: The risks for this study are minimal and appropriate 
safeguards are planned and in place to handle risks in a timely and appropriate manner. One area 
of risk of this study is loss of privacy. There are two ways that privacy is at risk: (a) through data 
collected and stored by the study team at UF, and (b) by data collected and stored by Apple 
through participants’ use of the Apple Watch. With regard to study team collected data, we cannot 
guarantee that data will not be unlawfully obtained. The steps described above in “Confidentiality” 
section will decrease the chances of this. With regard to data collected by Apple, any data the 
patients share with Apple is subject to the privacy terms of Apple. Patients will be informed during 
the consent process that the data they share with Apple is not protected by the University. Further, 
it is generally unsafe for women who are pregnant to engage in weight loss efforts, and it is an 
exclusion criterion in our study. As such, participants will be withdrawn from the study if they 
become pregnant. 
 
Protection against potential risks. Participants will fill out several questionnaires about 
themselves. While these generally carry no associated risks, it is possible that participants might 
experience some distress from completing these questionnaires due to the sensitive nature of the 
items. We will take all necessary steps to minimize discomfort and participants will be free to omit 
any questions that they do not wish to answer. The procedures and activities included in the 
EMPOWER intervention involve minimal risk. Participants will be informed that they can 
discontinue study procedures at any time, and they will not be penalized for doing so. The activity 
tests for the Back Performance Scale may produce discomfort and participants can stop these 
procedures at any time. An extensive literature on behavioral weight loss interventions suggests 
that there is very limited risk, particularly if patients are prescribed a calorie goal of greater than 
1,000 kcals/day. Participants will be encouraged to maintain a calorie intake within a safe range 
of 1,200-1,800 kcals per day. With any program that promotes physical activity, there is a small 
increased risk of musculoskeletal injury; however, the physical activity-focused portion of this 
intervention will emphasize finding safe activity and approaching it at a safe pace. The PI is a 
psychologist and is trained to deal with depression. Any participants whose responses during the 
group sessions or on the PROMIS Depression Short Form (raw score >33) indicate severe 
psychological distress (such as severe depression) will be interviewed by the site PI or other 
appropriately trained professionals for suicide risk and risk of harm to self and others. Participants 
will be assisted to the emergency room if danger is imminent or referred to either their physician or 
a mental health professional if necessary. 
 
8. Potential Benefits to Participants: Participation in this research will provide the participant with 
a first-hand look at research and provide them with the opportunity to participate in a new self-
management treatment for chronic musculoskeletal pain and overweight/obesity. Participants who 
complete the EMPOWER intervention may show improvement in pain and weight management. 
Ultimately, such knowledge may enhance quality of life and reduce pain in the targeted population, 
as well as lead to advances in the treatment of pain and excess weight in adults. Given the minimal 
risks associated with the study procedures, the risks are considered reasonable in relation to the 
potential benefits.  

13 
 
 
Importance 
of 
the 
Knowledge 
to 
Be 
Gained. 
Chronic 
musculoskeletalpain 
and 
overweight/obesity result in significant impairments, as well as tremendous individual and societal 
burden. The data obtained from the current study has the potential to advance treatment strategies 
for pain and weight management among middle-aged and older adults and may have broader 
implications for other medical populations likely to suffer from chronic pain and obesity. Moreover, 
our findings will enhance the understanding of underlying mechanisms contributing to treatment-
related effects in pain impact and weight loss. 
 
Inclusion of Women and Minorities. Given sex-specific prevalence of musculoskeletal pain and 
obesity,18, 61 both male and female subjects will be recruited with the goal of equal gender 
distribution. It is planned that adult minorities (45-80 years) will be included in the study sample in 
proportion to census levels in the Gainesville, Florida (Alachua County) community including: 
69.9% White, 20.6% Black/African-American, 6.3% Asian, 10.3% Hispanic or Latino, and 2.9% 
More than One Race. To ensure that the study sample includes census levels of minorities, we 
will assess their representation periodically over the course of the study and adjust recruitment or 
over-sample as needed. 
 
9. Conflict of Interest: There is no conflict of interest involved with this study beyond the professional 
benefit from academic publication or presentation of the results.  
 

14 
 
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