Leveraging Social Networks: a Novel Physical Activity Intervention for Senior Housing
Phase: NA
Conditions: Physical Inactivity
Sponsor: University of Michigan

Official Study Title: Leveraging Social Networks: a Novel Physical Activity Intervention for 
Senior Housing 
NCT Number: NCT06007664 
Document: Study Protocol and Statistical Analysis Plan 
Document date: 9/19/2024 
Study PI: Noah J. Webster 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

I. 
Research Design 
a. Objective 
i. In this pilot study, we will test the feasibility of pairing a social network-
based approach with a 6-week Occupational Therapist (OT)-led intervention 
administered remotely to increase physical function and activity among 
residents of a HUD subsidized independent-living senior housing 
community. The social network-based approach will involve systematic 
identification and involvement of influential human agents of change in the 
community (i.e., the most respected residents) to help sustain others’ 
participation in the OT intervention. The OT intervention will be comprised of 
a combination of adapted components from multiple evidence-based 
interventions including individual meetings with an OT and OT-led group 
sessions. The goal of the intervention is to increase physical function and 
activity among older adults through development of habits and skills that 
address barriers such as pain. 
b. Specific Aims 
i. List of Specific Aims 
1. Identify agents of change (AoC) and implement intervention. 
2. Evaluate feasibility of intervention implementation. 
3. Examine changes in secondary outcomes and differences in process 
and secondary outcomes by whether knew an AoC at baseline. 
ii. The following process hypotheses will be tested: At least 75% (3 of 4) of 
identified AoCs will accept the invitation to serve on Advisory Committee; 
AoC will attend at least 2 of 3 committee meetings; Participants will on 
average participate in at least 70% (7 of 10) of intervention activities; 
Residents knowing 1+ committee members at baseline will participate in 
more intervention activities compared to those who do not; The network 
influence on participation will be greater among residents reporting more 
pain at baseline compared to those reporting less pain.  
c. Background 
i. Physical activity (PA) is associated with many personal and societal benefits, 
e.g., alleviation of pain and improvement in physical function (1). Despite 
benefits, only 16% of people age 65+ engage in recommended levels of PA. 
Pain has been cited as a reason for PA intervention dropout (2,3). Research 
is needed to identify mechanisms that can sustain participation in 
behavioral interventions when barriers such as pain are present. One 
promising mechanism is interpersonal and social resources. Social ties 
affect health behaviors and have powerful effects among lower income 
older adults and those with health problems. 
1. Centers for Disease Control and Prevention Physical Activity – About 
Physical Activity – Why it Matters. Last accessed January 14, 2019 
from https://www.cdc.gov/physicalactivity/about-physical-
activity/why-it-matters.html. 

2. Centers for Disease Control and Prevention Adult participation in 
aerobic and muscle-strengthening physical activities - United 
States, 2011. Morb Mortal Wkly Rep. 2011;62:326-330. MMWR. [PMC 
free article] [PubMed] [Google Scholar] 
3. Centers for Disease Control and Prevention Physical Activity: How 
Much Physical Activity Do Older Adults Need? Last accessed 
January 14, 2019 from 
http://www.cdc.gov/physicalactivity/basics/older_adults/. 
 
II. 
Methodology 
a. Two sequential cohorts of 12 residents (24 residents total) living in a HUD 
subsidized independent-living senior housing community in [City Name] will be 
recruited for participation in this study. Both cohorts will receive the same 
intervention. The study includes the following components: 
b. All research activities will take place in-person, over the phone, or virtually on Zoom. 
c. Flyers will be distributed around the community to advertise the in-person 
recruitment presentation that will be hosted in the community room. The flyer will 
invite interested residents to attend the presentation to learn more about the 
program. 
d. At the in-person presentation, Noah Webster, the PI, will give a short presentation 
introducing the program and interested attendees will be invited to complete the 
screening interview in-person following the presentation to determine if they are 
eligible to participate. 
e. After the presentation, a second recruitment flyer will be distributed around the 
community with details about the program and an email and phone number for 
interested residents to contact the study team. 
f. Recruitment will be done in two phases, one for each cohort, and recruitment will 
remain open until 12 residents have been enrolled for each cohort. All residents in 
the community will be provided information about the study in the same manner 
and at the same time and we will screen and enroll people in the study on a first 
come basis. No person will be excluded from the study based on their sex/gender, 
race, or ethnicity. 
g. If the first group of residents taking part in the study does not include a large enough 
proportion of minority residents, we will initiate more targeted recruitment 
strategies to engage minority residents. This will involve: 1) Asking the community 
service coordinators to hand deliver the recruitment flyer to minority residents living 
in the community. After recruitment and screening of the first cohort is complete it 
will be determined if the above targeted recruited approach is needed for the 
second cohort. If it is needed, we will submit an IRB amendment at that time for this 
approach with the related recruitment materials (recruitment letter and phone 
recruitment script). 
h. We will also recruit from each cohort’s group of 12 study participants, two influential 
agents of change (AoC), who will be identified as being the most respected by other 
study participants. These study participants will be identified using data collected 

during the pre-intervention interview. Specifically, during the interview, study 
participants will be asked to identify people they know in the community. Then for 
each person they indicate knowing, they will be asked how much they respect that 
person on a 5-point Likert scale. The two most respected persons in each cohort will 
be invited via telephone to be a member of their cohort’s Advisory Committee. If 
either of the two persons declines the invitation, the 3rd most respected person will 
invite and so on until at least two agree to participate in this role. During the Advisory 
Committee recruitment call, the role of being a committee member will be 
described (i.e., attend three committee meetings and remind other participants to 
attend intervention activities and events). 
i. 
Informed consent will be obtained prior to participation in the screening interview. 
Screening interviews will be conducted in-person at the housing community and 
also by telephone. If the screening interview is conducted by phone, we will obtain 
verbal consent. The date that verbal consent is provided to participate will be noted 
on a copy of the informed consent document by the interviewer along with the 
participant’s name. Following the screening interview, the dated copy will be stored 
with the study records and a blank copy will be mailed to the participant to keep for 
their records. If the screening interview is conducted in-person, prior to beginning 
the interview the interviewer will go over the informed consent document with the 
participant. The participant will then be asked to sign the form if they consent to 
participate in the screening interview. The signed copy will be kept and stored with 
the study records, and the participant will be given an unsigned copy for their 
records. 
j. 
Participants will complete a 10-minute screening interview over the phone (or in-
person after community presentation) to determine if they are eligible to participate 
in the study. The screening interview will be administered through Qualtrics. Each 
person that is screened will be assigned a participant ID. The ID will be generated 
using the initials of the interviewer and the number of screening interviews 
conducted in-order by that interviewer. For example, the fifth person that [study 
team member with initials MK] is interviewing will be assigned “MK05.” An excel 
sheet that links participant identifying information and their ID will be password-
protected and saved on an O drive. Data will be kept for all residents that complete 
the screening interview to meet reporting requirements of the study sponsor 
(National Institutes of Health). 
k. All participants completing the screening interview will receive $10 cash for 
completing the interview, even if they are found to be ineligible. Those completing 
the survey in-person following the presentation will receive the money immediately 
after their interview. Those completing the survey over the phone and are found 
ineligible will be mailed the $10 in cash within the following the week. Those 
completing the survey over the phone and are found eligible, will receive the $10 in 
cash in-person when the study team delivers their study materials. 
l. 
The screening interview is set up to end immediately if the participant does not meet 
any of the eligibility criteria. At this point, the ineligible participant will be thanked 

for their time and asked to confirm their mailing address so that their incentive can 
be mailed to them. 
m. For those who are eligible to participate, the study team will set up: 1) a day/time for 
a 30-minute pre-program interview administered over the telephone; and 2) before 
the interview, a day/time for the study team to make a visit to the housing 
community to drop off study materials and obtain signed consent for the study. For 
those screened to participate on-site, this informed consent process will occur 
directly after the screening interview. At the time of the in-person visit, the study 
team member will go over the consent form with the participant and answer any 
questions the participant may have. The participant will then be asked to print their 
name, sign and date the informed consent document. The signed copy will be taken 
and kept with study records and the participant will be given an unsigned copy for 
keep for their records. Following this, the time and date for the participant’s pre-
program interview will be confirmed. 
n. The study materials will include a copy of the screening consent form for the 
participants to keep for their records, the $10 in cash for completing the screening 
interview, a tablet, a tablet charger cord, an HDMI cable to connect the tablet to a 
larger screen, a pedometer, an ActivPAL physical activity monitoring device wrapped 
in a water proof sleeve, Tegaderm adhesive/tape to attach the device to participant’s 
thigh, and a copy of the consent form to participate in the study for the participants 
to keep for their records. During this visit, the participants will be trained on how to 
use these devices. 
o. Participants will be provided with tablets and pedometers to use during the study. 
They will be asked to return the tablet upon completion of all study activities, but 
they can keep the pedometer. These materials will be hand-delivered to all 
participants after they are determined to be eligible to participate in the program, 
but before their pre-program interview. Pedometers will be used to track steps and 
help motivate and inspire participants to reach their activity goals. Following the 
first remote one-on-one meeting with the OT, the OT will provide each participating 
resident with a packet of educational materials, information that will be used and 
covered during group sessions and also include individual pedometer tracking 
sheets 
p. Eligible participants will complete a 30-minute pre-program (baseline) interview 
over the phone. They will be asked will be asked questions about things they do, 
physical activities they engage in, their social relationships with other residents in 
the community, and their health. 
q. Pre-program interviews will be administered through Qualtrics, and participants will 
be asked whether they know each of the other members of their intervention cohort. 
For each person they indicate knowing, they will be asked how much they respect 
that person on a 5-point Likert scale. The two most respected persons in each 
cohort will be invited via telephone to be a member of their respective cohorts’ 
Advisory Committee. If either of the two persons declines the invitation, the 3rd 
most respected person will be invited. This will continue until two people agree to 
serve on the committee. During the Advisory Committee member recruitment call, 

the role of being a committee member will be described (i.e., attend three 
committee meetings and remind other participants to attend intervention activities). 
Advisory Committee members will be asked to remind other cohort members to 
attend intervention activities only by making note of intervention activities during 
their regular interactions with the other participants (e.g., when see them in the 
hallway or in community common areas). They will not be asked to go out of their 
way to do this. 
r. Participants will be asked to wear a physical activity monitoring device (i.e., 
ActivPAL) on their thigh for 7 consecutive days after their pre- and post-program 
interviews. This is a small device that would be placed on your thigh with the help of 
a gentle adhesive. This device will continuously monitor their physical activity 
including activities like sitting, standing, walking and/or running. It will be recording 
the energy they had spent while performing the above-mentioned activities. When 
we retrieve this device from them, we will be looking at a number of values that tell 
us about their physical activity levels such as time spent sitting, standing, number 
of steps taken while walking and/or running, as well as energy spent per day. 
s. Participants identified to be potential Advisory Committee members must sign a 
separate consent form to serve in this role. This signed consent will be obtained in-
person when the study team returns to participants’ homes to pick-up the ActivPAL 
devices following the initial 7-day of wear. A copy of this consent form will be given 
to the participant to keep for their records. All the participants serving in this role will 
receive $100 in cash at the completion of the study. This money will be hand-
delivered to them at the end of the program in-person when picking up the ActivPAL 
device following the post-intervention 7-day of wear and the tablets. 
t. Once two cohort members have agreed to serve on the Advisory Committee we will 
hold an Advisory Committee Kick-Off Meeting. During the meeting the following will 
be discussed with the Advisory Committee Members: 1) the best day and time for 
OT weekly group sessions; 2) what the role of Advisory Committee member entails; 
2) any questions or concerns regarding the role, which includes: a) attending two 
additional committee meetings during weeks 3 and 5, and during these meetings 
provide feedback on how the program is going form their perspective; and b) 
reminding other cohort members to attend intervention activities. This will include 
making note of intervention activities only during their regular interactions with the 
other participants (e.g., when see them in the hallway or in community common 
areas). During this kick-off meeting the Advisory Committee Members will be 
instructed how to avoid coercive statements in their reminders. This will be 
facilitated by providing examples of both non-coercive and coercive statements. 
u. Participants will be asked to meet individually with the OT for 60-90 minutes via 
Zoom to evaluate the relationship between the participant and their apartment for 
engagement in safe mobility and activity; assess the participant’s activity 
performance, satisfaction, and barriers to activity engagement; establish 3-5 short-
term activity goals; and outline the beginning of an individualized home exercise 
program. This will include the OT providing guidance on use of the program provided 
pedometer and also demonstration of 1 or 2 exercises that can be performed safely 

in the home. The participating resident will then be invited to briefly perform the 
activities demonstrated and feedback will be provided by the OT. 
v. Participants will be asked to participate in 4 weekly one hour group OT sessions 
remotely via Zoom. Each session will include the following format: 1) teaching & 
education; 2) OT facilitated discussion on successes and challenges with: a) short-
term activity goals; b) implementing individualized plans; and c) strategies 
discussed at prior group sessions; and 3) activity demonstration, engagement and 
feedback. Each session will focus on a different topic for the teaching and 
education portion including: mobility, physical activity, pain management, and 
energy conservation. Each session will conclude with a brief group exercise activity 
demonstration and engagement led by the OT. The goal of this activity is to establish 
a foundation and facilitate development of habits. The activity will be repeated at 
the end of each of the four sessions, and will include rising from a chair, walking in 
place, and use of breathing techniques during the activity. Following the activity 
there will be a brief discussion of the experience and feedback provided by the OT if 
adjustments are needed. 
w. Over the course of the 4-weeks of group sessions, participants will be asked to 
briefly meet individually with the OT remotely via Zoom for 15-20 minutes once a 
week to answer any questions and or address problems that might arise. 
x. Following the completion of the group OT sessions, participants will be asked to 
again meet individually with the OT for 60 minutes via Zoom to re-evaluate the home 
for barriers to safe physical function and activity; re-assess activity performance, 
satisfaction, and barriers; revisit the 3-5 short-term activity goals established during 
the first one-on-one meeting, and revise as necessary; revisit the partial 
individualized home exercise program, and revise as necessary. This will include the 
OT re-demonstrating the participant’s partial individualized home exercise program 
including any revisions, leading the participant in engaging in the activities, and 
providing feedback. 
y. Participants will be asked to complete a 40-minute post-program (follow up) 
interview over the phone, administered through Qualtrics. They will again be asked 
questions about things they do, physical activities they engage in, their social 
relationships with other residents in the community, and their health. They will also 
be asked questions intended to measure the usefulness and satisfaction with the 
program. In the post-program interview we will ask participants again whether they 
know each of the other participants in their cohort, and for each they do know, how 
much they respect them. The purpose of asking these questions in the post-
program interview is to determine if the social connections between participants 
change over the course of the intervention. This is required in order to determine if 
and how the Advisory Committee members’ position in the network of participants 
(in terms of being the most respected) changes. It is hypothesized that there will be 
an increase in the number of participants reported known and also the level of 
respect will increase. If supported, this will provide evidence of an important 
secondary outcome of the intervention, which could be useful in sustaining 
participants’ engagement of behaviors introduced during the intervention. 

z. Finally, following the post-program interviews, participants will again be asked to 
wear an ActivPAL physical activity monitoring device on their thigh for 7 consecutive 
days. The study team will then visit the participants to pick-up the ActivPAL device 
and all other study materials (e.g., the tablet). At this visit, the participants will 
receive the remaining incentive in cash and told that this concludes their 
participation in the study. 
aa. Participants will receive $10 for completing the study screening assessment and if 
they are eligible to participate, they will receive an additional $25 for completing 
baseline and $30 for completing the follow-up study assessments. Additionally, they 
will receive $20 to wear an activity monitor for seven consecutive days at baseline 
and follow-up ($10 for wearing it at baseline and $10 for wearing it at follow-up), for 
a total of $85 for participating in all parts of the study. Agents of change (AoC) will 
receive $100 as a token of appreciation for their time to serve in this role, which will 
be provided following the committee’s third (and last) meeting. 
bb. Participation will be ended prematurely if a study participant contacts the study 
team and indicates that they would like to withdraw from the study or if the 
Occupational Therapist administering the intervention determines at any point that 
it is not safe for the participant to continue participating. If a participant withdraws 
from the study, the individual's data will be retained unless the participant requests 
to have their data destroyed. A participant's data will be destroyed upon their 
request. However, once findings are used in an analysis it will not be possible to 
remove a participant's information. 
cc. Deidentified data gathered during screening interviews (including from people who 
are found to be ineligible) will be kept to meet reporting requirements of the study 
sponsor (the National Institutes of Health). Identifying information including name, 
address, and phone number of those ineligible will only be kept to mail the 
screening interview incentive and will then be destroyed/deleted following the 
mailing. Identifying information of those eligible will be kept for study 
communication purposes. For participants who did not agree to be contacted for 
participation in future research, their identifying information will be 
destroyed/deleted at the time of study conclusion (i.e., after last visit is made to 
collect study materials and provide the last incentive). For participants who did 
agree to be contacted again in the future, their identifying information will be 
retained.  
Advantages of providing participants with tablets and using a virtual format for the OT 
intervention include improving accessibility by providing an opportunity for participants to 
engage in the program activities from the convenience of their home/apartment unit. This 
methodology and mode of delivery of the intervention aims to address potential barriers 
to sustain participation. 
 
 
 
 

Timeline per cohort: 
Week 1-2: 
Recruitment, eligibility screening, pre-intervention interview, and accelerometry 
data collection, Social network analysis and Identification of agents of change (AoC) 
Week 3: 
Formation of Advisory Committee, pre-intervention OT remote 1-on-1 meetings 
Week 4-7: 
OT-led remote group sessions, brief weekly remote 1-on-1 check-ins  
Week 8: 
Post-intervention OT remote 1-on-1 meetings  
Week 8-9: 
Post-intervention interviews and accelerometry data collection 
 
***Ame00140806*** To assist in the recruitment of the second cohort a letter will be provided 
to residents of [Community Name] along with the already approved recruitment flyer. Both will 
appear on a single piece of paper, with the new letter on one side and the already approved flyer 
on the other (back) side. The single piece of paper will be delivered to each residents' door. 
Also, the already approved recruitment flyer will be posted in public spaces in the community 
(e.g., on community bulletin boards). We will invite members of our first cohort to invite other 
community members they know to consider participating in the second cohort. They will not be 
asked to go out of their way to do this, and only do so during their regular interactions with other 
community members (e.g., when see them in the hallway or in community common areas). The 
following example will be provided to participants as a way they can talk about the program with 
other community members: "Hi [community member] I've been participating in the University of 
Michigan's T-VIDA program that you may have seen flyers for around the community. As part of 
the program I've had the chance to work with an Occupational Therapist to help me increase my 
physical activity. You might want to consider signing up for the second group. There is contact 
information on the flyer that we all just received at our doors if you are interested. " Pre-program 
interviews will be administered over the phone on in-person through Qualtrics. 
***Ame00141959*** Included with this amendment is two new questions added to the follow-
up (post-intervention survey) for participants in our first cohort. We recently received IRB 
approval to invite participants of our first cohort to help invite and recruit others in the 
community to participate in our second cohort. These new questions inquire about if they 
talked to other residents in the community about the program and if so, how many. 
***Ame00151969*** Included with this amendment is the change that we were not able to 
collect data from two sequential cohorts within the same HUD subsidized independent-living 
senior housing community community ([Community Name]). We will now being recruiting the 
second cohort at a second HUD subsidized independent-living senior housing community 
([Community Name]) in Ann Arbor, MI. The study intervention remains the same. 
 
 
 

III. 
Statistical design 
a. Sample size: Two sequential cohorts of 12 residents living in a HUD subsidized 
independent-living senior housing community in Ypsilanti, MI will be recruited for 
participation in this study. Both cohorts will receive the same intervention. The size 
of each cohort is capped at 12 to facilitate participation among all participants 
during group components of the intervention. A sample size of 24 was estimated to 
be sufficient in order to reach data saturation from quantitative process measures 
and theoretical saturation of themes from qualitative (i.e., open-ended) evaluation 
data (see Aim #2 below). 
b. AIM 1) Identify agents of change (AoC) and implement intervention. Within two 
sequential cohorts of 12 residents living in a HUD subsidized independent-living 
senior housing community, AoC will identified. 
i. Data analysis plan: Within each group of 12 study participants AoC will be 
identified using data collected during the pre-intervention interview. 
Specifically, during the interview, study participants will be asked to identify 
people they know in the community. Next, social network analysis will be 
conducted using these data with Ucinet. AoC will be identified as the top 
two study participants in their cohort on the social network measure of in-
degree centrality (i.e., number of other study participants who report 
knowing them). 
ii. Power analysis: A power analysis was not conducted for the proposed 
analysis due to the descriptive nature of the social network analyses. 
c. AIM 2) Evaluate feasibility of intervention implementation. Process outcomes will be 
examined following intervention implementation to determine which components 
were feasible. The process evaluation will be guided by a framework for evaluating 
complex interventions that assesses implementation, mechanisms of impact, and 
context. Process measures will include: 1) number of original AoC who accept 
invitation to serve on the Advisory Committee; 2) number of committee meetings 
attended by AoC; 3) number of individual (one-on-one) activities attended by study 
participants; 4) number of group activities attended by study participants; 5) total 
number of intervention activities attended by study participants; and 6) number of 
remote activities that study participants attended via zoom. Hypotheses: The 
following process hypotheses will be tested H2a: At least 75% (3 of 4) of identified 
AoCs will accept the invitation to serve on Advisory Committee; H2b: AoC will 
attend at least 2 of 3 committee meetings; H2c: Participants will on average 
participate in at least 70% (7 of 10) of intervention activities. 
i. Data analysis plan: 
1. Quantitative analysis: Descriptive analysis of process outcomes and 
intervention usefulness/satisfaction data from post-intervention 
interviews will be conducted using statistical software (e.g. SPSS). 
This will include examination of variable frequencies, measures of 
central tendency, and sample variation. 
2. Qualitative analysis: Analysis of open-ended data from questions 
about the usefulness and satisfaction with specific intervention 

components from the post-intervention interviews will begin with an 
open-coding process to develop a codebook. This will involve the PI 
and Graduate Student Research Assistants (GSRAs) working on the 
program. Each person will read the text responses and 
independently develop a list of themes in the data. Next the team 
will meet to discuss the themes with a goal of reaching consensus 
on the list of themes and develop and agreed upon definition for 
each theme. This information will then be compiled into a codebook 
containing the list of themes/codes and their definition. Following 
this, the GSRAs will conduct axial coding. This will include 
associating specific passages of text with the themes/codes 
developed during the open-coding process. This will be done using 
qualitative data analysis software (NVivo). Inter-rater reliability 
(kappa) will be calculated for an initial sample of text passages 
coded by the GSRAs. If discrepancies exist, they will be discussed 
and the process repeated until kappa >0.80. 
3. Power analysis: A power analysis was not conducted for the 
proposed analysis due to the descriptive nature of the proposed 
analyses, including analysis of open-ended text responses and 
descriptive analysis of process outcomes across the entire sample 
of study participants. 
d. AIM 3) Examine changes in secondary outcomes and differences in process and 
secondary outcomes by whether knew an AoC at baseline. 
i. Hypotheses: The following hypotheses based on Social Contagion Theory 
and the Convoy Model of Social Relations will be tested: H3a-Network 
influence: Residents knowing 1+ committee members at baseline will 
participate in more intervention activities compared to those who do not. 
H3b-Pain as modifier: The network influence on participation will be greater 
among residents reporting more pain at baseline compared to those 
reporting less pain. 
ii. Data analysis plan: Analysis for aim 3 will begin with descriptive analysis of 
secondary outcomes (physical function, PA, and pain) measured via self-
report during both the pre- and post-intervention interviews. This will be 
done using statistical software (e.g., SPSS) and will include examination of 
variable frequencies, measures of central tendency, and sample variation. 
Next change scores will be created to document change in these measures 
from pre- to post-intervention and descriptive analyses conducted on these 
variables. 
e. Analysis of accelerometry data: This study will use an accelerometer (activPAL) to 
measure physical activity among study participants. The activPAL is worn on the 
thigh continuously for 7-days. It has been shown to reliably measure sedentary time 
(including lying and sitting time) and activity intensity (i.e., estimates of energy 
expenditure) (Lyden et al., 2018). Raw data from the activPAL will be exported using 
activPAL provided software to a .csv file. The data will then be processed using an R-

package developed by developed specifically for activPAL data (Lyden et al, 2018). 
The data will be processed at the second level (1-second epochs). The same R-
package will then be used to sum the following over the 7-day period I which the 
device was worn: 1) sedentary (i.e. sitting/lying) time (i.e., number of 1-second 
epochs of <1.50 metabolic equivalents); 2) light activity (i.e., standing and stepping) 
time (i.e., number of 1-second epochs between 1.50 and 2.99); and 3) moderate or 
higher activity time (i.e., number of 1-second epochs 3.00 or higher). The above data 
preparation and analysis steps will be applied to both the pre- and post-intervention 
accelerometry data. As a final step we will create changes scores in each of the 
three objectively measured indicators of activity (sedentary, light, and moderate or 
higher). Following creation of these variables, descriptive analysis will be conducted 
on these variable including examination of frequencies, measures of central 
tendency, and sample variation. 
f. Hypothesis testing: To test the proposed hypotheses (i.e., to test the presence of 
social network influence), mean differences and corresponding 95% confidence 
intervals in process measures (e.g., number of intervention activities that study 
participants participated in) and changes in secondary outcomes described above 
will be compared between study participants who knew one or more AoC at 
baseline and those who did not. Next, within these two groups we will stratify by 
pain measures to explore descriptively whether pain moderates network influence 
on outcomes. 
g. Power analysis: A power analysis was not conducted for this pilot study given the 
proposed small non-representative sample, which is likely to produce inaccurate 
estimates of effect size and their corresponding standard errors. 
h. Reference: Lyden, K., Keadle, S. K., Staudenmayer, J., & Freedson, P. S. (2017). The 
activPALTM accurately classifies activity intensity categories in healthy adults. 
Medicine and science in sports and exercise, 49(5), 1022-1028. 
‘***Ame00151969*** Included with this amendment is the change that we were not 
able to collect data from two sequential cohorts within the same HUD subsidized 
independent-living senior housing community ([Community Name]). We will now being 
recruiting the second cohort at a second HUD subsidized independent-living senior 
housing community ([Community Name]) in Ann Arbor, MI. The study intervention 
remains the same 
IV. 
Foreseeable Risks to Participants 
a. 1) Risks Encountered During Data Collection: a) Rare and minimal risk of emotional 
distress from participating in survey interviews measuring psychosocial constructs. 
The interviewers conducting the pre- and post-program interviews will be trained to 
be sensitive to distress among participants. If a participant shows any signs of 
emotional distress the participant will be provided with a document listing the 
contact information of agencies they can consult with to receive counseling. b) skin 
irritation from Tegaderm adhesive used to waterproof and attach physical activity 
monitoring device (i.e., activPAL accelerometer) to study participants’ thigh. Study 
team members will train participants on how to properly attach this device to 

minimize irritation caused by improper attachment. There is also a minimal risk of 
an accidental breach or disclosure of identifying information. To prevent accidental 
breaches or disclosure of data collected, the study team will do the following: 
b. 2) In terms of the responses provided during the pre and post-program interviews: 
i. We will use of an online computer program (Qualtrics) to enter the 
responses during the pre and post-program interviews. 
ii. The program uses encryption and firewalls to ensure the data are not 
accessed by people outside of the study team. 
iii. Participant's name and other identifying information (phone number and 
address) will not be entered into the program. We will identify you in the 
program with a study ID consisting of only numbers. 
iv. Study data will be downloaded from the program and stored on a secure 
University of Michigan computer network where only study team members 
will have access. 
v. Only study team members will have access to a password protected file that 
connect you to your study ID. Additionally this file will be stored on a secure 
University of Michigan computer network and accessed from password 
protected computers. 
c. 3) In terms of the data collected using the activity monitoring device: 
i. Data collected via the activity monitoring device (activPAL) will only be 
accessible using a vendor provided docking station and software. 
ii. The data will only be downloaded from the device using a password 
protected computer at the University of Michigan and stored on a secure 
computer network. 
iii. The data will be deleted from the device before the device is used again with 
another study participant. 
iv. There is a serial number located on the device, which will be linked to the 
unique study ID, which will be stored in the aforementioned password-
protected file at the University of Michigan. 
v. If the device is lost or stolen, it will not be possible for the data stored on the 
device to be linked back to the participant. This research holds a Certificate 
of Confidentiality from the National Institutes of Health. 
d. 4) Risks Encountered During Intervention:  
i. Physical injury or distress during activities related and engaged in 
throughout the 6-week intervention, which will include establishing and 
working toward accomplishing goals related to physical function and 
activity. This could include increasing mobility and engaging in low to 
moderate intensity physical activities. To minimize risk of physical injury 
during the OT program activities, medical exclusion criteria common in 
mobility, function, and physical activity programs will be used. This includes 
excluding individuals for whom participation is not likely to be safe as well as 
more broadly those not likely to derive benefit from participation in this 
program. The OT will also work with all participants individually to create a 
personalized plan that is safest and most beneficial to each participant. 

Also, during the 4 weekly brief (15-20) individual meetings, the OT will inquire 
about the experience of any physical injury or discomfort related to the 
program activities. 
ii. Conflict or tension between resident agents of change (AoC) and other study 
participants. AoC in their role as members of the intervention Advisory 
Committee will be asked to remind other study participants in their cohort to 
participate in intervention activities. These reminders could be perceived as 
annoying or irritating by other study participants, which could result in 
relationship conflict or tension. To minimize this risk, AoCs will be provided 
information on best approaches and practices to remind study participants 
about intervention activities. This will include making note of intervention 
activities only during their regular interactions with them. They will not be 
asked to go out of your way to remind participants. They will also be 
instructed on how to avoid coercive statements in their reminders to 
participants. This will be facilitated by providing them with examples of non-
coercive statements to use when providing reminders. 
e. We believe the potential benefits to study participants outweigh the potential 
minimal to low risks. While participation in this study poses no serious risks to the 
study participants, given the focus on older adults and on physical function and 
activity during the intervention, safeguards to ensure safety of the participants will 
be put in place. These safeguards include: training for the interviewers conducting 
the pre- and post-intervention interviews to ensure sensitivity to distress among 
participants, providing phone numbers to call if emotionally upset or distressed, 
medical exclusion criteria common in mobility, function, and physical activity 
interventions will be used to exclude individuals for whom participation is not likely 
to be safe as well as more broadly those not likely to derive benefit from 
participation in this intervention, agents of change (AoC) will be provided 
information on best approaches and practices to encourage and remind study 
participants about intervention activities to avoid coercive statements in their 
reminders and decrease potential tensions between the residents. At least one 
study team member will join the Zoom calls for all group Occupational Therapy (OT) 
sessions. If a participant experiences any physical injury during the online OT 
sessions, the study team member will call 911 and send them directly to the 
participant's apartment. During the one-on-one meetings with the participants, the 
OT will discuss any physical injuries/ 
 
V. 
Subject Recruitment 
a. Study participants will be recruited at the community through use of flyers that will 
be posted around the housing community and delivered to residents' doors. The 
flyer will include the name and a brief description of the intervention. The flyer will 
indicate for interested residents to call the provided number or send an email if they 
have any questions or to schedule an eligibility screening. When residents call, they 
will be directed to leave a voicemail with their name and a call back number. The 
study team will then call them back, using the attached pre-screening phone call 

script, then administer the screening interview, over the phone. At the end of the 
screening interview, the study team will ask all eligible residents for a good time to 
drop off their study materials and obtain signed consent for the study. For those that 
send an email, they will receive a reply through email (attached below as the pre-
screening email reply) asking for a phone number and a good time for the study 
team to call them. They will then use the same pre-screening phone script and 
administer the screening interview, over the phone. 
b. The study team will also host an in-person presentation in the community room to 
allow the resident of [Community Name] to learn more about the program. After the 
presentation, the study team will administer the screening interview in-person for all 
interested residents to determine if they are eligible. The presentation will be 
advertised ahead of time through a separate flyer that will be distributed around the 
community and all residents will be welcome to attend and be screened, if 
interested. 
c. Recruitment will be done in two phases, one for each cohort, and recruitment will 
remain open until 12 residents have been enrolled for each cohort. All residents in 
the community will be provided information about the study in the same manner 
and at the same time and we will screen and enroll people in the study on a first 
come basis. No person will be excluded from the study based on their sex/gender, 
race, or ethnicity. 
d. If the first group of residents taking part in the study does not include a large enough 
proportion of minority residents, we will initiate more targeted recruitment 
strategies to engage minority residents. This will involve: 1) Asking the community 
service coordinators to hand deliver the recruitment flyer to minority residents living 
in the community. After recruitment and screening of the first cohort is complete it 
will be determined if the above targeted recruited approach is needed for the 
second cohort. If it is needed, we will submit an IRB amendment at that time for this 
approach with the related recruitment materials (recruitment letter and phone 
recruitment script). We will also recruit from each cohort’s group of 12 study 
participants, two influential agents of change (AoC), who will be identified as being 
the most respected by other study participants. These study participants will be 
identified using data collected during the pre-intervention interview. Specifically, 
during the interview, study participants will be asked to identify people they know in 
the community. Then for each person they indicate knowing, they will be asked how 
much they respect that person on a 5-point Likert scale. The two most respected 
persons in each cohort will be invited via telephone to be a member of their cohort’s 
Advisory Committee. If either of the two persons declines the invitation, the 3rd 
most respected person will invite and so on until at least two agree to participate in 
this role. During the Advisory Committee recruitment call, the role of being a 
committee member will be described (i.e., attend three committee meetings and 
remind other participants to attend intervention activities and events). Advisory 
Committee members will be provided a $100 cash incentive as a token of 
appreciation for their time serving in this role. This will be provided after the third 
Advisory Committee meeting and delivered by a study team member in-person. 

e. Deidentified data gathered during screening interviews (including from people who 
are found to be ineligible) will be kept to meet reporting requirements of the study 
sponsor (the National Institutes of Health). Identifying information including name, 
address, and phone number of those ineligible will only be kept to mail the 
screening interview incentive and will then be destroyed/deleted following the 
mailing. Identifying information of those eligible will be kept for study 
communication purposes. For participants who did not agree to be contacted for 
participation in future research, their identifying information will be 
destroyed/deleted at the time of study conclusion (i.e., after last visit is made to 
collect study materials and provide the last incentive). For participants who did 
agree to be contacted again in the future, their identifying information will be 
retained. 
***Ame00140806*** To assist in the recruitment of the second cohort a letter will be 
provided to residents of [Community Name] along with the already approved recruitment 
flyer. Both will appear on a single piece of paper, with the new letter on one side and the 
already approved flyer on the other (back) side. The single piece of paper will be delivered to 
each residents' door. Also, the already approved recruitment flyer will be posted in public 
spaces in the community (e.g., on community bulletin boards). 
f. We will invite members of our first cohort to invite other community members they 
know to consider participating in the second cohort. They will not be asked to go out 
of their way to do this, and only do so during their regular interactions with other 
community members (e.g., when see them in the hallway or in community common 
areas). The following example will be provided to participants as a way they can talk 
about the program with other community members: "Hi [community member] I've 
been participating in the University of Michigan's T-VIDA program that you may have 
seen flyers for around the community. As part of the program I've had the chance to 
work with an Occupational Therapist to help me increase my physical activity. You 
might want to consider signing up for the second group. There is contact information 
on the flyer that we all just received at our doors if you are interested." 
******Ame00151969***Included with this amendment is the change that we will be giving a 
presentation for our second cohort at [Community Name]. 
g. The staff of the community will assist in the best way for us to reach everyone living 
in the community. All residents in the community will be provided information about 
the study in the same manner and at the same time (via a recruitment flyer posted in 
common areas and delivered to doors) and we will screen and enroll people in the 
study on a first come basis. No person will be excluded from the study based on 
their sex/gender, race, or ethnicity. If the first group of residents taking part in the 
study does not include a large enough proportion of minority residents, we will 
initiate more targeted recruitment strategies to engage minority residents (e.g., 
targeted recruitment flyers, selective recruitment of minority residents from 
volunteers) for the second phase of recruitment. 

h. Flyers that will advertise the in-person recruitment presentation will be distributed 
around [Community Name] inviting all interested residents to attend and learn more 
about the program. At this on-site presentation, the study team will share 
information about the program and seek participants. If participants indicate 
interest at the event, then they will be screened in-person at a location in the 
community of their choosing and notified of eligibility immediately after. Following 
this presentation, a second recruitment flyer will be distributed around [Community 
Name] with an email and phone number for interested residents to contact. All 
interested residents will then be contacted to do the screening interview over the 
telephone. 
***Ame00151969*** For our second cohort, the same two flyers used previously for 
[Community Name], to advertise the in-person recruitment presentation, and distributed 
after the event will be used at [Community Name]. 
 
VI. 
Informed consent 
a. We will obtain informed consent three times during the study for three different 
types of participation: 1) participation in a screening interview to determine if the 
participant is eligible to participate; 2) participation in the intervention program and 
evaluation aspects (i.e., pre and post-program interview and wearing of an activity 
monitor (activPAL) for 7-days after the pre and post-program interviews; and 3) for 
two specific participants (i.e., the most respected in the cohort) agreement to serve 
on the program Advisory Committee. 
b. First, informed consent will be obtained prior to participation in the screening 
interview. Screening interviews will be conducted in-person at the housing 
community and also by telephone. If the screening interview is conducted by phone, 
we will obtain verbal consent. The date that verbal consent is provided to participate 
will be noted on a copy of the informed consent document by the interviewer along 
with the participant’s name. Following the screening interview, the dated copy will 
be stored with the study records and a blank copy will be mailed to the participant 
to keep for their records. If the screening interview is conducted in-person, prior to 
beginning the interview the interviewer will go over the informed consent document 
with the participant. The participant will then be asked to sign the form if they 
consent to participate in the screening interview. The signed copy will be kept and 
stored with the study records, and the participant will be given an unsigned copy for 
their records. 
c. If a participant is screened over the phone and they are determined to be ineligible 
to participate in the study, following their screening interview, they will be mailed a 
copy of the screening consent. 
d. If a participant is determined to be eligible to participate in the study, following their 
screening interview two appointments will be set-up: 1) to visit the participant in-
person in the housing community to obtained signed consent to participate in the 
study and drop-off study materials. This consent will be for participation in the pre-
program/intervention interview, pre-intervention accelerometry data collection, the 

intervention itself, the post-intervention interview, and post-intervention 
accelerometry data collection. 2) to complete the first study activity, a pre-
intervention interview over the telephone. 
e. For those screened to participate on-site, this informed consent process will occur 
directly after the screening interview. At the time of the in-person visit, the study 
team member will go over the consent form with the participant and answer any 
questions the participant may have. The participant will then be asked to print their 
name, sign and date the informed consent document. The signed copy will be taken 
and kept with study records and the participant will be given an unsigned copy for 
keep for their records. Following this, the time and date for the participant’s pre-
program interview will be confirmed. 
f. Consent will be collected a third time for only specific participants, the study’s 
identified agents of change (AoC) for their role in the intervention as a member of 
the intervention’s Advisory Committee. Two AoC per cohort will be recruited over the 
telephone. If they are interested in the role, consent to take on the role will be 
obtained in-person when visiting the participant to pick up their activity monitor. 
g. At the time of the in-person visit, the study team member will go over the consent 
form with the participant and answer any questions the participant may have about 
the role. The participant will then be asked to print their name, sign and date the 
informed consent document. The signed copy will be taken and kept with study 
records and the participant will be given an unsigned copy for keep for their records. 
All study informed consent documents will contain a statement informing 
participants that results from this study will be posted online at ClinicalTrails.gov. 
 
VII. 
Confidentiality/security/privacy 
a. To ensure participants' privacy is protected during the duration of the study, all 
phone calls, zoom meetings, and interviews (both over the phone and in-person) will 
be conducted in a private setting. 
b. During the home visits to drop off study materials, we will ask to speak to the 
participants alone in a private setting of their choice. The management and staff at 
[Community Name] will not be told information about the participants including but 
not limited to, who screened for the study, who is participating, who has ended their 
participation early. This information (including answers to questions about social 
relationships within the community) will also not be shared with any other residents 
or participants. 
c. ***Ame00151969*** The management and staff at [Community Name] will not be 
told information about the participants including but not limited to, who screened 
for the study, who is participating, who has ended their participation early. This 
information (including answers to questions about social relationships within the 
community) will also not be shared with any other residents or participants. 
 
VIII. 
Retention of data 
a. To ensure protection of study participant confidentiality during collection and 
storing of study data, each study participant will be assigned a unique ID. This ID will 

be used during data collection activities to ensure immediate separation of 
participant identifying information from their study data. Additionally, all signed 
informed consent documents (containing study participant name) will be kept in a 
locked filing cabinet in the PI’s office. 
b. 1) In terms of the responses provided by participants during the screening and pre 
and post-program interviews: 
i. We will use of an online computer program (Qualtrics) to enter the 
responses you provide us during your pre and post-program. The program 
uses encryption and firewalls to ensure your data are not accessed by 
people outside of the study team. 
ii. Participants' name and other identifying information (phone number and 
address) will not be entered into the program. We will identify participants in 
the program with a study ID consisting of only numbers and interviewer 
initials. 
iii. Study data will be downloaded from the program and stored on a secure 
University of Michigan computer network where only study team members 
will have access. 
iv. Only study team members will have access to a password protected file that 
connects participants names to their study ID. Additionally, this file will be 
stored on a secure University of Michigan computer network and accessed 
from password protected computers. 
v. -The National Institutes of Health, who is providing the funding for this study 
may inspect and copy records pertaining to this research study. Also, a 
description of this study will be publicly available on www.ClinicalTrials.gov, 
as required by U.S. law. This description will not include information that can 
identify the participants. At most, the description posted on this website will 
include a summary of the results. You can search this website at any time. 
c. 2) In terms of the data collected using the activity monitoring device: 
i. Data collected via the activity monitoring device (activPAL) will only be 
accessible using a vendor provided docking station and software. 
ii. Participant data will only be downloaded from the device using a password 
protected computer at the University of Michigan and stored on a secure 
computer network. 
iii. Participant data will be deleted from the device before the device is used 
again with another study participant. 
iv. There is a serial number located on the device, which will be linked to a 
participant's unique study ID, which will be stored in the aforementioned 
password-protected file at the University of Michigan. 
v. If the device is lost or stolen, it will not be possible for the data stored on the 
device to be linked back to a specific study particpant. Protection of 
confidentiality will be ensured during required data and safety monitoring 
and reporting. Specifically, data will be presented in a blinded manner in the 
quarterly data and safety reports submitted to the study’s locally appointed 
safety officer, and the study sponsors. 

*****Ame00137652***** Protection of confidentiality will be ensured during required data 
and safety monitoring and reporting. Specifically, data will be presented in a blinded 
manner in the data and safety reports submitted to the study’s sponsor. 
 
IX. 
Subject payments or incentives 
a. Participants will receive $10 for completing the study screening assessment and if 
they are eligible to participate, they will receive an additional $25 for completing 
baseline and $30 for completing the follow-up study assessments. Additionally, they 
will receive $20 to wear an activity monitor for seven consecutive days at baseline 
and follow-up ($10 for wearing it at baseline and $10 for wearing it at follow-up), for 
a total of $85 for participating in all parts of the study. Agents of change (AoC) will 
receive $100 as a token of appreciation for their time to serve in this role, which will 
be provided following the committee’s third (and last) meeting. 
b. The incentives are a token of appreciation of the time taken to complete data 
collection activities. Amounts are consistent with others similar in time. For agents 
of change (AoC), their incentive is a token of appreciation for the time to participate 
in multiple meetings as well as involvement in intervention administration (e.g., 
reminding others to attend meetings). 
c. Participants will only be compensated accordingly for completing the specific study 
activity. If they withdraw from the study, they will be compensated for the activities 
they completed prior to withdrawal. 
 
X. 
Healthcare Treatments and Procedures 
a. Participants will be involved in virtual group occupational therapy sessions. These 
sessions will be held on Zoom where an Occupational Therapist (OT) will lead four 
weekly one hour sessions with participating residents. Each session will include the 
following format: 1) teaching & education; 2) OT facilitated discussion on successes 
and challenges with: a) short-term activity goals; b) implementing individualized 
plans; and c) strategies discussed at prior group sessions; and 3) activity 
demonstration, engagement and feedback. Each session will focus on a different 
topic for the teaching and education portion including: mobility, physical activity, 
pain management, and energy conservation. Each topic is detailed in a document 
attached in the ‘Additional Supporting Documents’ section of this application. Each 
group session will conclude with a brief group exercise activity demonstration and 
engagement led by the OT. The goal of this activity is to establish a foundation and 
facilitate development of habits. The activity will be repeated at the end of each of 
the four sessions, and will include rising from a chair, walking in place, and use of 
breathing techniques during the activity. Following the activity there will be a brief 
discussion of the experience and feedback provided by the OT if adjustments are 
needed.