A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older Adults
Phase: NA
Conditions: Chronic Pain, Obesity, Sedentary Lifestyle
Sponsor: Wake Forest University Health Sciences

 
10/30/2020 
 
 
Study Title: A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older 
Adults 
 
NCT03377634 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
10/30/2020 
 
Study Title: A Mobile Intervention to Reduce Pain and Improve Health (MORPH) in Obese Older 
Adults 
Co-Principle Investigators: Amber Brooks, MD, and Jason Fanning, PhD 
Co-Investigators: Barbara Nicklas, PhD, Edward Ip, PhD, Jack Rejeski, PhD 
Sponsor or Funding Source: NIA/NIH 
Background, Rationale, and Context 
Chronic pain is a pervasive1 and costly health condition among older adults that is associated with wide-
ranging adverse health outcomes including falls2, declining mobility1, and increasing functional 
disability3. Obesity exacerbates many of these health issues, contributing to a higher frequency of 
intractable pain episodes, increased pain severity, multi-site pain4, and the use of stronger opioid 
medications compared to normal weight individuals with chronic pain5. In addition, older adults who 
suffer from chronic pain are significantly more sedentary than those without chronic pain6. Despite 
evidence relating increased sedentary behavior to pain7,8, non-pharmacological treatments have largely 
focused on moderate-to-vigorous physical activity9 (MVPA).  
 
Recent evidence from an intervention designed to decreased SB demonstrated the approach is effective in 
preventing weight regain following weight loss10. This technology-driven intervention—a mobile 
intervention to reduce pain and improve health (MORPH)—combines telecoaching and an mHealth 
application (app) that integrates data from multiple sources—i.e., activity monitors, food logs, scales, and 
daily psychosocial assessments—to extend the reach of our intervention while better tailoring the content 
to be patient-centered. Importantly, intervening on SB by promoting postural shifts (i.e., breaks in sitting) 
and light physical activities across the day can result in a larger total volume of physical activity than 
MVPA11, can be incorporated into daily life12 and is associated with fewer aversive physical sensations 
than MVPA13. Light activities are likely to be more tolerable to older adults, especially those suffering 
from chronic pain. An intervention combining telecoaching with individually-adaptive mHealth tools can 
be delivered remotely, enabling lifestyle change among older adults with chronic pain, for whom 
transportation is a common barrier to the receipt of healthcare14.  
 
This study consists of two phases: (1) an intervention development phase wherein feedback from 
members of the target population will be used to iteratively refine the mHealth app and to convert the 
weight loss and sedentary behavior components of the intervention to a telecoaching model, and (2) a two 
group randomized controlled pilot trial (RCT) in 30 obese (BMI=30-45 kg/m2), low-active, older (55-85 
years) adults with chronic pain randomized to either 12-weeks of active intervention or a wait-list control.  
 
Objectives  
The aim of this study is to develop and test the feasibility and acceptability of a novel, patient-centered 
intervention to reduce chronic pain in older adults, leveraging the combination of telecoaching and 
individually-adaptive mHealth tools to decrease both body mass and sedentary behavior. MORPH 
addresses the NIH’s 2016 National Pain Strategy’s call to: 1) expand non-pharmacological treatment 
options in older adults, who are particularly susceptible to the side effects of opioid and other pain 
medications; 2) develop accessible treatments that are individually-tailored; and 3) increase the 
development of self-management programs15. 
 
 
 

 
10/30/2020 
 
Aims and Hypotheses 
Specific Aim 1: To use an iterative user-centered design process to develop a mHealth application, to 
adapt the weight loss and sedentary behavior components of the intervention to a telecoaching model, and 
to evaluate the usability and feasibility of the intervention for obese, older adults with chronic pain. 
Hypothesis 1: As a result of the iterative, person-centered design process, we expect scores on the system 
usability scale16 to improve across the development period. We expect fewer alterations to be required as 
the development process proceeds, and we expect fewer use and usability issues to present during the in-
home trial. Note that data collected during this period will largely be qualitative in nature. 
 
Specific Aim 2: To conduct a pilot RCT to provide initial evidence for the effect size associated with the 
proposed intervention on pain and physical function and to estimate the sample size needed for a RCT 
that is designed to compare the effects of the intervention versus usual care on pain ratings and physical 
function. 
Hypothesis 2: We expect the provision of the in-home application to contribute to significant 
improvements in pain ratings and physical function compared to the usual care condition.  
 
Methods and Measures 
Study Overview: For both phases of the study, eligible participants will own an Android or iPhone 
smartphone, have pain in at least 2 of 5 areas (i.e., back, neck, shoulders, hips, knees) on most days 
during the previous 3 months, no contraindication for participation in exercise, and will be aged 55-85 
years, obese (BMI=30-45 kg/m2, weight-stable (i.e., no weight loss or gain > 5% in the past 6 months), 
and  low-active (i.e., engaging in less than 2 days/wk of structured physical activity for at least 20 
minutes). Excluded individuals will be unable to walk without assistive devices for short distances, or will 
have cognitive impairment as indicated by a Montreal Cognitive Assessment57 score less than 22. During 
Phase I, participants will engage in a structured 1:1 development session wherein they will be exposed to 
isolated interface elements (A/B testing), will interact with the mHealth app with minimal guidance, will 
narrate thought processes while engaging with the app (Think Aloud) and will complete a brief structured 
interview. They will then use the app in-home for one week, and will finalize their participation in the 
study by completing the System Usability Scale16. During Phase II, individuals will be recruited to 
participate in a 2-group randomized controlled trial wherein they will be assigned to either a 12-week 
mHealth + telecoaching intervention or a wait-list control group. The primary outcomes for this pilot 
study will be pain ratings on two PROMIS measures17 and performance on the Short Physical 
Performance Battery18. Additionally, those who participated in Phase I testing will be offered 
participation in the 12-week program. Those who express interest will complete the program as a 
standalone wave to avoid contaminating other Phase II participants. 
Recruitment of Study Participants 
Our recruitment goals include: 50% women and 30% minority. We will recruit these individuals using 
community-based recruitment strategies, including newspaper and radio advertisements, e-mail, direct in-
clinic recruitment approach as well as, portal messages, and mass mailings. Specific inclusion/exclusion 
criteria (see table) are in place to eliminate those that may be adversely affected by the interventions or 
that are not able to comply with the interventions. To reduce adverse effects of dietary weight loss, we 
exclude individuals that are non-obese, those with recent weight loss, those who have osteoporosis, and/or 
anyone on medications that may affect bone density. To reduce fall risk, we set an upper age limit on 
recruitment of 85 years and will exclude anyone who cannot walk unassisted over a short distance or who 
has had >1 fall in the past year (see Table below).  
 

 
10/30/2020 
Participant Screening and Randomization 
All individuals who respond to our recruitment strategies will call a toll-free phone number and a recruiter 
will describe the study and perform a brief screen for general eligibility. They will be asked about their  
Criteria 
Inclusion 
Exclusion 
Assessment 
Age 
55-85 years  
 
Self-report 
Obesity status 
BMI=30-45 kg/m2 
 
Measured on scale 
Functional status 
 
-Dependent on cane or walker to 
walk a short distance;  
>1 fall (injurious or non-injurious) 
in past year  (does not include falls 
where participant was 
pushed/pulled by another object 
and was not injured) 
-Vision insufficient to read a 
smartphone screen, unable to read 
 
Self-report 
Weight stability 
Weight stable—no loss or 
gain (±5%) in past 6 months; 
 
 
Self-report 
 
Physical 
activity 
status 
 
-Participation in regular resistance 
training and/or > 20 mins on 2+ 
d/w of aerobic exercise in past 6 
months 
-No contraindication to exercise 
Self-report 
Cognitive status   
 
Montreal Cognitive Assessment  
<22 
Questionnaire 
Co-
morbidity/health 
status 
 
--Uncontrolled 
hypertension 
(>160/90 mmHg); 
--Current or recent past (within 1 
year) severe symptomatic heart 
disease, 
uncontrolled 
angina, 
stroke, chronic respiratory disease 
requiring oxygen, neurological or 
hematological 
disease; 
cancer 
requiring treatment in past yr, 
except non-melanoma skin cancers 
BP measurement 
 
Self-report on  
Medical History form 
 
 
 
Medication use 
 
Regular use of: growth hormones, 
oral 
steroids, 
or 
prescription 
osteoporosis medications 
Self-report and 
medication inventory 
Research 
participation 
Willing to provide informed 
consent; Agree to all study 
procedures and assessments; 
Able 
to 
provide 
own 
transportation to study visits; 
owns an Android or Apple 
smartphone.  
Current participation in other 
research study targeting pain, 
physical activity, or weight loss 
Self-report 
Pain Status 
Pain in 2 or more of the 
following sites on most days 
for the previous 3 months: 
back, neck, shoulders, hips 
 
 

 
10/30/2020 
and/or knees 
Surgery 
 
Joint replacement or orthopedic 
surgery within previous 6 months 
or planning to have orthopedic  
surgery in the next 6 months 
 
age, weight, height, current physical activity habits, body weight in the past year, medical history, current 
medications, and eligibility to participate. All participants must conform to the study’s 
inclusion/exclusion criteria. All participants, with questions regarding medical history will be cleared by a 
study physician (AB) and then will be approved for participation by study PI 
Those who pass phone screening will be scheduled for a 1:1 development session (Phase I) or screening-
visit (Phase II) at a WFBMC-affiliated facility. The screening visit will allow participants to complete 
self-reported questionnaires and tests of physical function. During both phases, participants provide 
written informed consent and complete a HIPAA authorization form in accordance with our IRB policy 
prior to collection of any data. For both phases, the first visit begins with measurement of weight and 
height to calculate BMI. Individuals who meet the BMI criteria will undergo a medical history and a 
cognitive test (MoCA19). The medical history (including blood pressure) will exclude those not meeting 
inclusion criteria with regard to medication use, health status, or cognitive status. Eligible participants 
will be randomized to treatment using a web-based randomization scheme, stratified by sex with random 
block sizes.  
Study Procedures 
A timeline for phases I and II is provided below. 
Phase I – Person-Centered Design and Development 
Phase I of the study will occur during the first year of the study period. During months 1 – 3, the web-
based mobile application will be finalized to include novel data streams (i.e., connected scale, activity 
monitor, digital food log, ecological momentary assessment), initial user interface and interaction 
elements (to be provided by the study graphic designer), and animated educational content. Then, a select 
team of study investigators (lead by JF) will conduct preliminary testing of the study procedures, 
including the use of the application and attached peripherals, and the use of the conference calling system 
to be used in the study. During months 4-12, participants will be recruited to attend 1:1 sessions. After 
signing informed consent documents and completing baseline assessments, participants complete a series 
of A/B tests. In brief, a focused set of features are isolated and small variations made by the team’s 
graphic designer (e.g., button shape or color, positioning of a feedback bar). These are presented to the 
participant who is asked to select their preference. This process will allow the team to identify the 
preferences and needs of the older adult smartphone user. Next, the participant will receive a brief 
introduction to the purpose of MORPH. The participant will receive minimal guidance to facilitate 
movement within the app, but will otherwise be asked to explore at will. Participants will be asked to 
narrate their thought process (i.e., to “think aloud”) as they utilize the app. They will be asked to 
continuously narrate their internal dialogue as they were interacting with the interface. Audio recordings 
and detailed notes will be obtained during this process. This Think Aloud protocol provides insight into 
the subjective experience of the individual as they utilized the interface. Audio content will be 
transcribed, and key findings from the session brought to the core intervention team. Necessary iterations 
will be decided upon, the study graphic designer will provide updates in an A/B fashion, and 
Development
Alpha/Beta Testing
Preliminary User Testing (n = 15)
Iterative Development
m1 - m3
m4 - m12
m13
m14 m15 m16 m17 m18 m19 m20 m21 m22 m23 m24
Test Run (n=5), Feasibility & Usability Testing (n = 30)
Phase 1
Phase 2

 
10/30/2020 
improvements made to the interface following each small grouping of interviews (n=1-3 interviews). 
Finally, after the interview session, the participant will bring all study peripherals to their home (i.e., 
Fitbit device, connected scale), and engage with the app for one week. During this period, the participant 
will also complete one burst of ecological momentary assessment. Following this one-week period, the 
participant will return to the research site to return equipment, complete the System Usability Scale16, and 
receive remuneration for their time. This process is to be completed iteratively until the investigative team 
is confident that no further iterations are needed, and participants no longer provide meaningful interface 
critiques. 
Phase II – MORPH Pilot Study 
Whereas Phase I is concerned with ensuring the usability and desirability of the application for the target 
population, Phase II is meant to establish the efficacy of the program when delivered in the home. 
Accordingly, Phase II is a randomized controlled pilot study in which participants (N=30) will enter the 
study in up to three small waves.  We will begin with a trial run of ~5 individuals who will all be assigned 
to the intervention condition to pilot all facets of the intervention.  For the duration of each wave, 
intervention staff will keep detailed notation of software and usability challenges, and iterations will be 
made in between waves. Notably, these iterations will not affect the overarching structure of the 
intervention, but will ensure all components of the program are maximally usability for the older adult 
with chronic pain.  The participants that are not randomized to active intervention after screening will 
receive monthly phone calls to keep them engaged in the study until they return for the follow up visit. 
Content of Weight Loss (WL) & Sedentary Behavior (SB) Intervention. In sum, the MORPH pilot study is 
a 12-week randomized controlled trial. The MORPH app is embedded in a 9-week telecoaching 
intervention that is prefaced by 3 weeks of 1.5-hour group sessions for a total intervention spanning 12 
weeks, plus 2 pre-study orientation appointments. The 3 weeks of initial face-to-face contacts are used to 
(a) establish the group-mediated nature of the telephone coaching contacts, (b) create connection between 
group members that will be built upon via the app, (c) teach basic skills needed for successful weight loss 
and reduced SB (e.g., mindfulness, food tracking, use of the app), and (d) develop competence in use of 
the mHealth app. The WL component targets a 3-5% reduction in body weight. The SB component 
targets: (a) increasing the number of postural shifts across the day, and (b) increasing the performance of 
valued activities related to independent living, including balance, strength, and mobility activates that will 
augment caloric restriction to promote WL and increase functional capacities as assessed by the short 
physical performance battery (SPPB). The distal goal of the activity component is to increase steps across 
the day in the range of 5,000 to 10,000 steps based on individual abilities. Individual goals for caloric 
intake will be prescribed to achieve an energy deficit of ~400 kcal/d from daily weight maintenance 
energy requirements (resting energy expenditure x activity factor of 1.3 for sedentary adults). The lowest 
caloric goal prescribed will be 1100 kcal/d for women and 1200 kcal/d for men. The content for the 
dietary weight loss intervention is based on our extensive experience in community-based trials and our 
most recent materials from CLIP-II, whereas the SB intervention builds upon the protocol we are using in 
EMPOWER (R01 AG051624-01) and has efficacy in preventing weight regain as evident from our 
published work with older adults10. Adaptation of these materials to the telecoaching + mHealth model 
will occur in Phase I. 
 
Each participant will receive the Fitbit activity monitor at least 2 weeks prior to the start of the 
intervention and will be asked to continue their typical level of daily activity. These data will be used to 
establish a baseline for the SB intervention that can be tailored to each individual. Week 1 will be used as 
an accommodation period20 with data from week 2 being used to assess average daily postural shifts and 
volume of activity. Baseline activity and weight will be built upon via weekly proximal goals, which will 
be set in collaboration with the study interventionist via email each week.  
 

 
10/30/2020 
The intervention incorporates principles from social cognitive theory21 and the group dynamics literature22 
into 12 weekly sessions that include nutritional education and ongoing assistance in integrating physical 
activities into daily life, teaching and reinforcement of self-regulatory skills, exposure to mindfulness-
based stress reduction and pain management, and strategies that optimize social connection. An additional 
innovation is a series of highly engaging animated cartoon videos to reinforce and summarize session 
content. All session content will also be incorporated into bi-weekly tailored feedback. Finally, the 
participant’s daily affective and pain experiences are used in the app to cue the participant to practice 
mindfulness and self-regulatory strategies at key moments throughout the day23. 
 
Ecological Momentary Assessment 
Ecological momentary assessment (EMA; assessments collected in near real time and in the real world24) 
will be utilized to (a) gain insight into the relationships between key daily health behaviors (sleep, diet, 
activity) and pain and fatigue; (b) provide highly personalized feedback following the first week of each 
month on the relationships between an individual’s health behaviors and their pain and fatigue responses 
across the day; and (c) guide the delivery of just-in-time mindful movement prompts. To minimize 
participant burden, we will use 1-week EMA bursts during weeks 1, 5, and 9. During each burst, 
participants will receive approximately 6 brief (i.e., <60 seconds) daily assessments delivered via 
smartphone within 2-hour intervals throughout waking hours, and will report current level of pain (on an 
11-point Likert scale) and affect (the Feelings Scale26), as well as whether any medications had been 
taken since the previous survey. These variables can be expected to influence SB and eating patterns, 
along with previous night’s sleep duration and quality, which will be reported on the first assessment of 
each day (assessed via items from the Pittsburgh sleep quality index27). These assessments will be used to 
identify daily risk periods: “pain peaks” and “affect troughs”. We expect these two variables in particular 
to contribute to higher levels of SB and unhealthy eating14,28. These daily risk periods will be identified in 
feedback to the participant, and will also be used to craft “awareness alerts”. Specifically, these data will 
be utilized by the program staff to create up to two daily Fitbit silent alarms. These prompts aim to cue 
the participant to both be mindful of their current state, and to engage in brief mindful-based exercises—
which are practiced in weekly telecoaching sessions—to improve affect, reduce pain, and prevent 
overeating or extended sitting. The aim is to set prompts prior to daily pain periods and/or sitting period 
to encourage movement to suppress sitting-related stiffness and pain. These prompt schedules will be 
updated automatically with each EMA burst, and participants will have the opportunity to manually alter 
the timing of daily prompts. Those in the wait listed control condition will also complete EMA bursts on 
the same schedule as those in the intervention arm, and these will provide insight into the effect of the 
intervention on daily behaviors and trajectories of pain and fatigue. 
 
Device Use 
Because device ownership is a requirement for this study, those who lose access to the device during the 
intervention will be noted, but will be asked to return for post-study assessments. We are not, however, 
able to provide a device. All participants will be provided a Fitbit and connected scale for the purposes of 
the study. If the Fitbit is lost, stolen, or damaged, participants will be provided with a replacement. If a 
participant withdraws from the study, they will be asked to return the Fitbit. After completion of the last 
study visit, participants will be allowed to keep the Fitbit, as the devices become worn with time. The 
connected scales and ActivPal will be returned to the research center upon completion of the study. 
  
Study Assessments 
During Phase I, study assessments occur during the primary study visit (P1V1), and again after 
completion of the one-week trial (P1V2) 
 
During Phase II, study assessments occur during a baseline physical function and questionnaire 
appointment (P2V1), and a technological orientation (P2V2). Note that no measures are collected during 

 
10/30/2020 
the P2V3 nutrition appointment. Final assessments are collected during the final week of the intervention 
or following the intervention (P2V4). A table of assessments collected during Phase II is provided below.

 
10/30/2020 
MORPH Measures 
Outcome 
P1V1 
P1V2 
P2V1 
P2V2 
P2V3 
P2 Inter-
vention 
P2  
Weeks 
1,5,9, 12 
P2V4 
P2V5 
*Control 
only 
P2V6 
*Control 
only 
P2 Control 
Inter-
vention 
Week 
 
0 
1 
0 
0 
 
1-12 
1,5,9,12 
12-14 
15 
16 
17-29 
A/B Preferences 
Primary  
Non-RCT* 
X 
 
 
 
 
 
 
 
 
 
 
Retrospective 
Think Aloud 
Coding 
Primary 
Non-RCT* 
X 
 
 
 
 
 
 
 
 
 
 
System Usability 
Scale 
Primary 
Non-RCT* 
 
X 
 
 
 
 
 
 
 
 
 
Issue Logs 
Other 
 
X 
 
 
 
X 
 
 
 
 
X 
Demographics & 
Medical History 
Other 
X 
 
X 
 
 
 
 
 
 
 
 
MOCA 
Other 
X 
 
X 
 
 
 
 
 
 
 
 
Adverse Events 
Other 
 
X 
 
 
 
X 
 
X 
 
 
X 
CES-D 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
FACIT 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Pittsburgh 
Fatigability 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Pittsburgh Sleep 
Quality Index 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
SF-36 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Satisfaction with 
Physical Function 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Self-Efficacy for 
Walking 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Movement Self-
Efficacy 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Self-Efficacy for 
Managing Eating 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
MAAS 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Power of Food 
Other 
 
 
X 
 
 
 
 
X 
 
 
 
Food Cravings 
Other 
 
 
X 
 
 
 
 
X 
 
 
 
Perceived Stress 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
Body Weight 
Secondary 
X 
 
X 
 
 
 
 
X 
 
 
 

 
10/30/2020 
Height, BP, Pulse 
Other 
X 
 
X 
 
 
 
 
X 
 
 
 
PROMIS Pain 
Intensity Scale (3 
item) 
Primary 
*RCT Phase 
X 
 
X 
 
 
 
 
X 
 
 
 
PROMIS Pain 
Interference Scale 
(8 item) 
Primary 
*RCT Phase 
X 
 
X 
 
 
 
 
X 
 
 
 
Short Physical 
Performance 
Battery (SPPB) 
Primary 
*RCT Phase 
 
 
X 
 
 
 
 
X 
 
 
 
Mobility 
Assessment Tool 
Short Form (MAT-
SF) 
Other 
 
 
X 
 
 
 
 
X 
 
 
 
In-Home Weight 
(Connected Scale) 
Other 
 
 
 
 
 
X 
 
 
 
X 
 
Sedentary Activity 
& Transitions 
(ActivPal) 
Secondary 
 
 
X 
 
 
 
 
X 
 
 
 
Steps, Light and 
Vigorous Activity 
(ActivPal) 
Secondary 
 
 
 
X 
 
 
X 
*only week 
12 
 
 
 
 
Sedentary Activity 
& Transitions 
(Fitbit) 
Other 
X 
 
 
 
 
X 
 
 
 
X 
 
Steps, Light and 
Vigorous Activity 
(Fitbit) 
Other 
X 
 
 
 
 
X 
 
 
 
X 
 
Daily Pain (EMA) 
Other 
X 
 
 
X 
 
X 
X 
 
 
X 
 
Daily Affect (EMA) 
Other 
 
 
 
X 
 
 
X 
 
 
 
 
Medication used? 
(EMA) 
Other 
 
 
 
X 
 
 
X 
 
 
 
 
App Use (count) 
Secondary 
 
 
 
 
 
X 
 
 
 
 
 
Retention 
Secondary 
 
 
 
 
 
 
 
X 
 
 
 

 
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Study Measure(s) 
1. Baseline demographic data will be recorded based on participant self-report. Medical information on 
prior and existing co-morbidities and hospitalizations will be ascertained by self-report and confirmed by 
direct query of the participant at the screening visit. We will also record medication use by asking 
participants to bring in all medications (including nutritional supplements).  
 
2. Adverse events will be assessed by asking participants at each assessment visit, and during weekly 
telecoaching calls. Participants will be asked to report any health changes, injuries, etc. and these will be 
recorded using the Adverse Event Form.  
 
3. Physical function (a primary outcome of this study) will be assessed using the Short Physical 
Performance Battery (SPPB18), which is a measure of lower-extremity function consisting of walking 
speed, balance, and repeated chair stands. Perceptions of physical functioning will be assessed using the 
Mobility Assessment Tool Short Form (MAT-SF29).  
 
4. Pain (the second primary outcome of this study) will be assessed using the PROMIS17 pain intensity 
(3 item) and pain interference (8 item) scales. 
 
5. Body weight: Body weight will be measured in-clinic on the same scale. As a process measure, we 
will also obtain body weights weekly from individuals in-home using a connected scale. 
 
6. Sedentary behavior, minutes of light and moderate-vigorous physical activity, and energy 
expenditure: We will use the ActivPALTM monitor to assess treatment effects on daily SB and physical 
activity.79-84 Participants will be asked to wear the devices continuously (they are water resistant) for 7 
consecutive days at each time point. Data will be downloaded at the end of each 7-day period and cleaned 
and summarized for statistical analyses. We will also obtain daily Fitbit data, which will provide ongoing 
assessments of physical activity and sitting behavior. 
 
7. Psychosocial Assessments: Since attachment-related behavior is an important facet of group-mediated 
interventions and known to be associated with responsiveness to behavior change, we will assess anxiety 
and avoidance experienced in close relationships.91 As social cognitive measures, we will assess self-
efficacy expectations related to physical activity30,31 and eating behavior32, and outcome expectations for 
physical function and appearance33. Perceived stress will be evaluated with a short-form of the perceived 
stress scale34, trait mindfulness with the MAAS35, and control in resisting food using the power of food 
scale36. Depression will be assessed using the CES-D37, and health-related quality of life using the SF-
3638. 
 
8. Sleep: Sleep can be expected to influence both daily pain and daily sitting behavior, so sleep will be 
assessed in two ways. First, the Pittsburgh Sleep Quality Index27 will be used to assess sleep at each 
assessment visit. Additionally, sleep quality will be assessed on a 4-point scale upon waking during the 
first EMA of each day during EMA burst periods. 
 
9. Craving Assessment: (Phase II only)At baseline and follow-up visits, and following an overnight fast, 
we will administer a multidimensional state measure of craving39. The measure of craving provides 
subscales that assess the desire to consume highly valued foods, the positive reinforcement resulting from 
their consumption, the relief from negative feeling states that these foods provide, lack of control related 
to food consumption, and hunger. 
 
10.  Fatigue measures: The following fatigue questionnaires will be administered: 1) FACIT Fatigue 
Scale40; and 2) Pittsburgh Fatigability Scale41. 

 
10/30/2020 
 
11. Cognitive function will be assessed during screening using the Montreal Cognitive Assessment 
(MoCA)19; participants must score ≥22 to be eligible.  
12.  Ecological Momentary Assessment: EMA will be used to study within-person and within-day 
interactions between sleep quality and duration (assessed via items from the Pittsburgh Sleep Quality 
Index27), affect (assessed via the feelings scale), and level of pain. 
During weeks 1, 5, and 9, participants will complete week-long daily assessments. Participants will be 
instructed to complete assessments upon waking up in the morning and immediately prior to going to bed 
at night. Additionally, each participant will receive up to five daily text message prompts with links to 
secure web-based questionnaires. Each assessment will take the average user less than one minute to 
complete, and will contain all items with the exception of sleep items, which will be assessed only during 
the first assessment of the day. 
13. App Use: We will note how many times the app is opened from the home screen throughout the study. 
14. Retention: We will record retention as the number of consented participants who complete baseline 
and follow-up testing. 
Statistical Analyses 
For Specific Aim 1 (development of mHealth application), we will use simple descriptive statistics and 
qualitative data to evaluate usability and feasibility of the intervention. For Specific Aim 2 (pilot RCT), 
the goal of the analysis is to (1) estimate the effect size of the intervention such that the results can be 
used to power a future larger RCT, and (2) explore appropriate methods and models for analyzing 
EMA/EMI data. We plan to estimate the effect size using the following generalized linear model: 









covariates
2
1
0
Int
Y
Y
BL
FU
, where Y represents the primary outcomes (SPPB score, 
PROMIS pain scales), subscripts FU and BL denote measurement at week 12 follow up and baseline 
respectively, Int represents intervention status, 
 represents regression coefficient, and 𝜀 represents 
random error. Because of the small sample size, we may include important covariates (e.g., gender, age) 
into the model if the two arms happen to be highly imbalanced. In case covariates are used, effect sizes 
will be estimated using the adjusted values from the above equation. We also plan to conduct similar 
analyses of secondary outcomes of the RCT (e.g., WL & sedentary behavior) using the aforementioned 
model and apply the appropriate model link function if the secondary outcome is not continuous. 
Although our primary goal is to determine feasibility and effect size using data collected from baseline 
and week 12, we do recognize the potential value of the intensively collected EMA data. Exploratory 
analyses, including visualization will be used to study the utility of EMA data, which include both pain 
and psychosocial variables. For example, we will determine if preliminary evidence supports the cross-
lagged reciprocal relationship between pain and self-efficacy. Another example is the examination of 
intra-person vs inter-person variation in the EMA variables. The exploratory analysis is expected to 
inform the analytic plan for a future larger study.  
 
Database management: All data except those generated from the activity monitors, connected scales, and 
EMA (these will be coded automatically) will be entered into the web-based study database as collected. 
Our data entry system will protect confidentiality and data security and the use of text containing 
identifying information will be avoided. Activity monitor data will be downloaded to a server and the 
summary data merged with other study data. Final analysis datasets will be stored in SPSS and SAS. All 
data will undergo range checks at the time of data entry and will be examined periodically by histograms 
and bivariate scatterplots to check for inconsistencies, unusual data needing further verification, and 
outliers. Plots of longitudinal observations will be used to inspect for unusual changes that need to be 
verified against source documents.  
Human Subjects Protection 

 
10/30/2020 
Subject Recruitment Methods:  
Subject Recruitment Methods: We will recruit these individuals using community-based recruitment 
strategies, including newspaper and radio advertisements, e-mail, direct in-clinic recruitment approach as 
well as, portal messages, and mass mailings.  We will also advertise in the Aging Center’s VITAL 
newsletter and participate in community outreach events.  
Informed Consent: The informed consent process will follow the procedures of the WFSM Institutional 
Review Board. The potential participant is mailed the informed consent form and asked to read it before 
their initial visit. The form is written in simple, easy-to-understand language.  At first contact with the 
prospective participant during the initial visit, the study staff member will explain the purpose, methods 
and extent of the study. We require study staff to review all of the key aspects of the study verbally with 
the potential participants and to question potential participants to ascertain whether s/he has understood 
the information. Potential participants are encouraged to ask questions regarding the consent form and the 
study. A copy of the signed and dated consent form will be given to participants, and the original 
document will be placed in their individual study file, which will be stored in a secure location. In 
compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the Standards for 
Privacy of Individually Identifiable Health Information of the Department of Health and Human Services, 
we will access personal health information only after obtaining informed consent. 
Potential Study Risks: There are inherent potential risks to human subjects who participate in any 
research study and the potential risks to study participants in this study are listed below. Any injuries or 
illnesses (adverse events) during the course of a participant’s enrollment in the study are monitored 
regularly. 
 
Physical function tests: There is a small risk of injury during the physical function tests, such as 
muscle strains or pulls, falls, or joint injury. Risks will be minimized by having experienced/trained 
staff conducting these assessments. A warm-up and range of motion practice will be conducted before 
testing. If a participant reports pain, dizziness, or other medical problem, the test will be terminated.   
 
Weight loss at any age include the concomitant loss of lean (muscle and bone) tissue along with 
fat mass loss. However, the clinical impact of this muscle and bone loss is not known. Since most 
adults with obesity have a higher muscle mass and bone density, this risk is mitigated by excluding 
individuals who are non-obese and less likely to benefit from weight loss. 
o During the behavioral weight loss classes, we will also provide nutrition education 
regarding adequate intake of calcium and Vitamin D, including encouraging use of 
dietary supplements. Participants will be counseled to consume, either using food or 
dietary supplements, at least 1300 mg of calcium and 1000 IU of Vitamin D daily.  
 
Risks of the movement intervention are minimal, but also may include an enhanced fall risk. This 
will be minimized by reviewing environmental factors that are known to increase fall risk.  
 
Risks associated with wearing the activity monitors are minimal, but may include minor skin 
irritations.  Participants will be instructed to note these on their log and if it becomes bothersome 
to remove the device and call staff for further instructions. 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
study participants, and maintaining all study information in a secure manner. To help ensure subject 
privacy and confidentiality, only a unique study identifier will appear on the data collection form. Any 
collected patient identifying information corresponding to the unique study identifier will be maintained 

 
10/30/2020 
on a separate master log. The master log will be kept secure, with access limited to designated study 
personnel. Following data collection, subject identifying information will be destroyed at the earliest 
opportunity, consistent with data validation and study design, producing an anonymous analytical data 
set. An entirely separate identifier number will be used for any data collected via the web, and the key 
stored offline in a secure location. Data access will be limited to study staff. Data and records will be kept 
locked and secured, with any computer data password protected. No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the study. 
Data and Safety Monitoring 
The co-PIs, along with the study physician, will be responsible for the overall monitoring of the data and 
safety of study participants. In addition, we will use the WFU Pepper Center’s appointed Data Safety 
Monitoring Board. This board meets twice a year and reviews all studies that are supported by the WFU 
Pepper Center. A copy of the report will be reported to the IRB after each meeting. 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any major AE (i.e., any serious injury, including all SAEs) will be recorded and reported to the co-PIs 
immediately after completing any and all actions that are necessary to protect the subject’s health and 
safety. Minor AEs will be recorded and reported within seven days. A description of the event, and the 
date and location of the event will be recorded on the AE Reporting Form. The PIs and the Medical 
Director will meet quarterly, or as needed, to review all reported events and these will be compiled and 
reported in aggregate to the data safety officer.  Within 24 hours of notification of any SAE, the PIs will 
report the event to the WFSM Institutional Review Board (IRB), if required.  
 
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