Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study
Phase: NA
Conditions: Physical Inactivty, Wellbeing, Mindfulness
Sponsor: University of Minnesota

Page 1 V10 February 2021 
 
 
 
STUDY PROTOCOL 
Mindful Movement for Physical Activity and Wellbeing in Older Adults: A Community Based 
Randomized Hybrid Effectiveness-Implementation Study 
 
 
Principal Investigator: 
Roni L. Evans, MS, DC, PhD 
Associate Professor 
Integrative Health & Wellbeing Research Program  
Earl E. Bakken Center for Spirituality & Healing 
C504 Mayo Memorial Building, University of Minnesota 420 
Delaware Street S.E. 
Minneapolis, MN, USA 55455 
 
 
Supported by: 
The National Center for Complementary and Integrative Health 
                  R21 AT009110-01A1, R21 ClinicalTrials.gov Identifier: NCT03114709 
 
R33 Award Number: R33AT009110 
ClinicalTrials.gov Identifier: NCT03929393       
 
UMN IRB ID: 1611S99323 
Version 10, February 2021 
Approved by NCCIH/NIH: NA 
Approved by UMN IRB: March 1, 2021 
 
 
 
 
 
 
 
 
 
 
 

Page 2 V10 February 2021 
 
 
 
TOOL REVISION HISTORY 
 
 
Version 
Number 
Version 
Date 
History 
Summary of 
Revisions Made 
Protocol Section 
Impacted 
Regulatory 
and 
Oversight 
Impacted 
Regulatory/Oversight
, Approval Date(s) 
V1.0 
Nov 7, 
2016 
Revised 
proposal as 
protocol to 
UMN IRB 
NA 
NA 
NA 
IRB: 12/10/16 
Required 
transition to 
Ethos submitted 
8/4/2017; 
approved 
10/24/17 
Clarification 
of eligibility 
criteria 
(baseline 
physical 
activity 
levels, 
disabilities) 
Inclusion Criteria. 
Clarification re: 
physical activity BL 
levels and 
disabilities. 
-Added: self-report of 
<140minutes of MVPA 
per week (in 
10 minute bouts) in the 
past 3 months at initial 
screen and BL1. 
-Changed: 
Accelerometer 
recorded <150 
minutes to 
<100 minutes of MVPA. 
NA 
NA 
NCCIH:02/16/17 
Clarification 
of eligibility 
criteria 
(contraindica
tions to 
mindfulness) 
Exclusion Criteria 
-Added 
contraindications to 
participating in a 
mindfulness 
intervention (e.g. 
severe mental health 
disorders) 
NA 
NA 
NCCIH:02/16/17 
Notice of 
Award and 
approved 
Transition 
Milestones 
and R33 
Specific Aims 
See below 
NA 
NA 
NCCIH: 03/01/17 
Key 
Personnel 
Change 
Pamela Jo Johnson 
removed from Key 
Personnel due to no 
longer employed at 
institution (04//26/16) 
Study 
Team 
Roster 
UMN IRB 
NCCIH: 04/27/17 

Page 3 V10 February 2021 
 
 
V2.0 
Nov 13, 
2017 
Revised V1.0 
protocol to 
accommodate 
NCCIH 
template and 
reflect 
developments 
from 
Planning 
Phase; will 
submit to 
UMN IRB 
once NCCIH 
approval 
received 
Revised Specific Aims 
to include NCCIH 
approved Transition 
Milestones in R21; 
original 2 specific aims 
expanded to 3 to 
accommodate 
Transition Milestones 
1. Study 
Objectiv
es 
DSMP; 
UMN IRB 
NCCIH: 12/15/17 

Page 4 V10 February 2021 
 
 
 
Version 
Number 
Version 
Date 
    History 
Summary of Revisions 
Made 
Protocol Section 
Impacted 
Regulatory and 
Oversight 
Impacted 
Regulatory/Oversig
ht, Approval 
Date(s) 
V2.0 
Nov 13, 
2017 
Clarification of 
eligibility 
criteria 
(Participant 
Level- 
pregnancy, 
contraindication
s to 
mindfulness 
practices, 
concurrent 
participation in 
similar 
interventions) 
Exclusion Criteria 
(Participant-level) 
-Added: pregnancy 
-Operationalized: 
contraindications to 
mindfulness practices (e.g. 
severe mental health 
disorders) for appropriate 
screening to optimize 
patient safety 
-Added: Current or 
upcoming participation in 
educational programs similar 
to those under study in terms 
of content (e.g. mindfulness 
based, general health) format 
(e.g. group sessions, 
facilitator led) and length of 
delivery (1-1.5 hours per 
week x 4-8 weeks) to the 
experimental and control 
interventions offered in the 
study. 
4. Selection 
and 
Enrollment of 
Participants 
DSMP; 
UMN IRB 
NCCIH: 12/15/17 
Clarification of 
eligibility 
(Facility, 
Organizational 
Levels) 
Inclusion Criteria 
-Clarified: Facility level must 
work at the YMCA (e.g. 
staff), but are not in 
leadership positions, and 
willing to participate in 
qualitative data collection; 
Organizational are defined as 
individuals at the YMCA 
who influence the strategic 
planning of the organization 
(e.g. hold leadership 
positions) and willing to 
participate in qualitative data 
collection. 
4. Selection 
and 
Enrollment of 
Participants 
NCCIH: 12/15/17 
V2.0 
Nov 13, 
2017 
Interventions 
-Changed from 10 classes 
over 12 weeks to 8 classes 
over 8 weeks 
5. Study 
Interventio
ns 
DSMP; UMN 
IRB; Consent 
Form 
NCCIH: 12/15/17 
V2.0 
Nov 13, 
2017 
Interventions 
-Added: use of video of 
content experts within class 
sessions
5. Study 
Interventio
ns
DSMP; 
UMN IRB 
NCCIH: 12/15/17 

Page 5 V10 February 2021 
 
 
 
Version 
Number 
Version 
Date 
History 
Summary of Revisions 
Made 
Protocol 
Section 
Impacted 
Regulato
ry and 
Oversigh
Impacted 
Regulato
ry/Oversi
ght, 
V2.0 
Nov 13, 
2017 
Interventions 
-Changed: Name of control 
interventions from 10 Keys to 
Healthy Aging to10 Keys to 
Health and Wellbeing. 
-Updated with new scientific 
evidence; adapted program 
wording, messaging to be 
consistent with community 
partner's 
5. Study 
Interventions 
DSMP; UMN 
IRB; 
Consent 
Form 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Screening 
-Changed: initial phone 
screen to be done either on 
phone OR online 
6. Study 
Procedures 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Evaluation 
-Added: social 
connection/assurance 
outcome measure 
9. Statistical 
Considerations; 
9.5 Outcomes 
DSMP; 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Evaluation 
-Added open ended survey 
questions, field notes, as a 
qualitative data collection 
methods 
9. Statistical 
Considerations; 
9.5 Outcomes 
DSMP; 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Evaluation 
-Changed: end of intervention 
follow up changed from 12 
weeks to 9 weeks to align 
with modified intervention 
period 
6. Study Procedures; 
9. Statistical 
Considerations; 
9.5 Outcomes 
DSMP; 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Participant 
compensatio
n 
Changed: participant 
compensation to align with 
modified participation period 
(12 weeks to 8 weeks) 
4. Selection and 
Enrollment of 
Participants 
DSMP; UMN 
IRB; 
Consent 
Form 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Screening 
Informed consent process 
will now occur in a group 
setting and/or one-on-one 
with participants. 
Previously, informed 
consent occurred one-on- 
one with the PI, or 
designee. 
4. Selection and 
Enrollment of 
Participants 
DSMP; 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Key 
Personnel 
Change 
Added: Craig Schulz to Key 
Personnel 
Study Team Roster 
UMN IRB 
NCCIH: 
12/15/17 

Page 6 V10 February 2021 
 
 
V2.0 
Nov 13, 
2017 
Key 
Personnel 
Change 
Changed: Linda Hanson 
from Non-Key to Key 
Personnel 
Study Team Roster 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Nov 13, 
2017 
Key 
Personnel 
Change 
Changed: Brent Leininger 
from Non-Key to Key 
Personnel 
Study Team Roster 
UMN IRB 
NCCIH: 
12/15/17 
V2.0 
Mar 5, 
2018 
Updated 
Research Staff 
Included McGargness and 
Ziegler as facilitators 
Study Team Roster 
UMN IRB 
NCCIH: NA 
V3 
Mar 29, 
2018 
Change to 
Inclusion 
Criteria 
Self-report of <140 minutes of 
MVPA per week (in 10 minute 
bouts, in the past 3 months at 
phone screen and BL1) AND 
accelerometer recorded <100 
minutes of MVPA (in 10 minute 
bouts, between BL1 and BL2) 
changed to  
Self-report of <140 minutes of 
MVPA per week (in 10 minute 
bouts, in the past 3 months at 
initial screen and BL1) OR 
accelerometer recorded <100 
minutes of MVPA (in 10 minute 
bouts, between BL1 and BL2) 
4. Selection and 
Enrollment of 
Participants 
UMN IRB 
NCCIH: 
3/28/17 (email 
from program 
officer) 
V4 
Nov 28, 
2018 
Change to 
Inclusion 
Criteria 
 
 
 
Self-report of <140 minutes of 
MVPA per week (in 10 minute 
bouts, in the past 3 months at 
initial screen and BL1) OR 
accelerometer recorded  changed 
to 
Self-report of <140 minutes of 
MVPA per week (in 10 minute 
bouts, in the past 3 months at 
phone screen and BL1) AND 
accelerometer recorded <100 
minutes of MVPA (in 10 minute 
bouts, between BL1 and BL2) 
 
 
 
4. Selection and 
Enrollment of 
Participants 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V4 
Nov 28, 
2018 
Change to 
Intervention 
Changed: Name of control 
interventions from 10 Keys 
to Health and Wellbeing to 
Keys to Health and 
Wellbeing 
5. Study 
Interventions 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V4 
Nov 28, 
2018 
Key Personnel 
Change 
Changed: Alex Haley, Douglas 
Kennedy from non-Key to Key 
Personnel 
Study Team Roster 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 

Page 7 V10 February 2021 
 
 
V4 
Nov 28, 
2018 
Updated 
recruitment 
methods 
Updated recruitment methods 
to include CTSI Clinical Data 
Repository, community 
listening and information 
sessions to enhance minority 
recruitment 
4. Selection and 
Enrollment of 
Participants 
 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V4 
Nov 28, 
2018 
Change to 
Exclusion 
Criteria 
 
 
 
Serious mental health or brain 
conditions (bipolar disorder, 
schizophrenia, psychotic disorder 
or problems, Alzheimer’s, 
dementia, major depressive 
disorder).  
to 
Serious mental health or brain 
conditions (bipolar disorder, 
schizophrenia, psychotic disorder 
or problems, Alzheimer’s, 
dementia, major depressive 
disorder). Self-report of 
diagnosis by a health provider 
AND health care provider does 
not provide clearance to 
participate 
4. Selection and 
Enrollment of 
Participants 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V4 
Nov 28, 
2018 
Update to 
Sample Size 
considerations 
Updated variability estimates, 
between group differences; no 
change to sample size 
9. Statistical 
considerations 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V4 
Nov 28, 
2018 
Update to 
Focus on R33 
Activities 
Removed R21 activities so 
protocol focuses solely on R33 
activities 
All 
UMN IRB 
NCCIH: 
2/19/19 
IRB: 3/8/19 
V5 
Mar 13, 
2019 
Update to 
Recruitment of 
Candidate 
Participants 
Clarified timing of Community 
Listening Sessions and Study 
Information Meetings 
4.3 Study 
Enrollment 
Procedures 
UMN IRB 
NCCIH 
NCCIH: 
3/26/19 
IRB: 4/18/19 
V6 
May 16, 
2019 
Update to 6.2.2 
Enrolled individuals will 
commence their allocated 
intervention up to 10 business 
days post randomization versus 
7-10 business days post-
randomization.  
6.2.2 Enrollment, 
Baseline, and 
Randomization  
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Update to 6.2.4 
Week 9 Follow-Up data can be 
collected between -7  and  + 15 
business days following W9 
date;  
 
Added “if applicable” to AE 
form at all time points 
 
6.2.4 Follow-Up 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 

Page 8 V10 February 2021 
 
 
V6 
May 16, 
2019 
Schedule of 
Evaluations 
Added study completion form  
6.1-Schedule of 
Evaluations 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Schedule of 
Evaluations & 
Adverse Events 
Table updated to be congruent 
with text in section 7. AEs will 
be collected post-
randomization. This is 
consistent with the DSMP.  
 
 
The Safety Officer (DSMB) 
will adjudicate events, with 
input as needed, from the PI or 
designee. 
 
 
Study related AE/SAEs will be 
followed to 
stabilization/resolution post 
end of study participation.  
 
 
 
 
Information in this section is 
redundant and covered in 
section 7.4.2 
 
 
6.1-Schedule of 
Evaluations 
 
 
7.4 Adverse Events and 
Serious Adverse Events & 
7.4.1 Characteristics of an 
Adverse Event 
 
 
 
7.4.2 Time Period and 
Frequency 
Collection and Time 
Period. 
 
 
 
 
7.6 omitted 
UMN IRB 
NCCIH 
NCCIH: 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Monitoring 
Non-SAEs will be reported to 
the IRB annually as part of the 
continuing review process 
10.3.6 Monitoring 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 IRB: 
8/6/2019 
V6 
May 16, 
2019 
Protocol 
Deviations 
Removed reference to protocol 
deviations in 10.3.4. Added a 
definition of protocol deviation 
and included a list of examples 
10.3.5 Protocol 
Deviations 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Participating 
Sites 
Added Maplewood YMCA 
NA 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
8/6/2019
V6 
May 16, 
2019 
Intervention 
logistics 
Clarified that classes may 
proceed with less than 8, or 
more than 16 persons. The PI 
will make the final 
determination as to whether or 
not a smaller or larger class is 
appropriate. 
5.2.3 Intervention 
logistics 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Schedule of 
Evaluations; 
Outcomes, 
Enrollment, 
Baseline, 
Randomization 
Added outcome measure: 
interoceptive awareness. To be 
collected at baseline, W9, 
W26, and W52 
6. Study Procedures; 9.5 
Outcomes; 6.2.2 
Enrollment, Baseline & 
Randomization  
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 

Page 9 V10 February 2021 
 
 
V6 
May 16, 
2019 
Consent 
Procedures 
Included language that 
describes when participants 
will be re-consented 
4.3.4 Consent Procedures 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
May 16, 
2019 
Outcomes 
Vector magnitude (  2751 
CPM was changed to   2752 
CPM) 
9.5 Outcomes 
UMN IRB 
NCCIH 
NCCIH: 
7/17/19 
IRB: 8/6/2019 
V6 
June 27, 
2019 
Data analysis 
Clarified how clustering effect 
will be assessed in the analysis 
9.6 Data Analyses 
NCCIH 
NCCIH: 
7/17/19 
V7 
March 
2020 
Intervention 
Logistics 
Participant can attend 
intervention sessions at the 
remotely using UMN 
approved, HIPAA compliant 
videoconferencing due to 
concerns; changes made due to 
COVID-19 outbreak. 
5.1.1 Intervention 
Administration/Duration 
UMN IRB 
NCCIH 
IRB: 4/6/2020 
V7 
March 
2020 
Outcomes 
Week 26 Follow-Up data can 
be collected between -7  and  + 
60 business days following 
W26 time point; changes made 
due to COVID-19 outbreak.  
6.2.4  Follow-Up 
UMN IRB 
NCCIH 
IRB: 4/6/2020 
V8 
April 2020 
Outcomes 
COVID-19 Impact and Zoom 
questions added 
9.5 Outcomes 
6.1 Schedule of 
Evaluations 
UMN IRB 
IRB: 
4/21/2020 
V9 
June 2020 
 
All references to in-person 
screening, interventions, 
training, and follow-up visits 
were removed. These are 
replaced by remote visits 
done by phone and/or 
videoconference.  
Multiple sections of the 
protocol.  
UMN IRB 
previously 
approved 
NCCIH: NA 
V9 
June 2020 
 
Included Young and 
Schroeder as facilitators; 
removed Ziegler.  
Updated Study Team 
Roster 
UMN IRB 
previously 
approved 
NCCIH: NA 
V9 
June 2020 
 
Updated Participating Sites 
section 
NA 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
 MMSE will now be conducted 
only on participants with 
suspected cognitive decline 
versus all participants to 
decrease burden. 
4.2.1 Inclusion Criteria 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 

Page 10 V10 February 2021 
 
 
V9 
June 2020 
 
Participants will be excluded 
if they cannot commit to 
attending >70% of intervention 
sessions via videoconference) 
 
Major anxiety disorder added 
to contraindications to 
mindfulness practices per 
UMN IRB RNI00004599 
4.2.2 Exclusion Criteria 
 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
Recruitment plans updated to 
include remote recruitment 
initiatives 
4.3.2 Recruitment of 
Candidates 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020
V9 
June 2020 
 
Compensation increased to 
$210.00. An extra $10 was 
included to account for the 
pre-intervention orientation 
(W0). 
4.3.2 Recruitment of 
Candidates 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
Consent procedures updated 
to include e-Consent. 
Participants who cannot e-
Consent will be mailed a 
consent formed to sign and 
mail back if they want to 
participate. 
 
Reference to in-person 
consent procedures was 
removed.  
4.3.4 Consent procedures 
 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
We updated how the data analysis 
will account for class effects with 
the transition away from physical 
sites to remote intervention 
delivery. 
 
4.3.5 Randomization 
procedures 
 
9.2.2 
Randomization/Treatment 
Assignment Procedures 
 
9.6 Analysis 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
A W0 orientation session prior to 
the start of the intervention 
sessions has been implemented to 
orient participants to the video-
conference, virtual group 
environment.  
 
Participants will receive 
reminders prior to each session.  
 
Participants will receive 
additional information including 
tips to ensure optimal learning, 
comfort and safety 
6.2.4 Intervention & 
Follow-up 
5.1.1. Administration & 
Duration 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
All training will be conducted 
remotely.  
5.1.4 Intervention 
Training 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 

Page 11 V10 February 2021 
 
 
V9 
June 2020 
 
Intervention fidelity will not be 
done in-person and sessions will 
not be audio-recorded. Zoom 
interface at UMN does not allow 
recording of PHI.  
5.2.2 Intervention fidelity UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
Participants will be given 
instructions on how to participate 
remotely.  
 
Participants will be asked about 
Zoom experience, tech needs and 
capabilities, and waist size 
 
Participants BL exams will be 
done via videoconference and/or 
phone 
 
Deaconess completed by 
participants prior to BL or during 
BL evaluation 
 
Accelerometers will be mailed to 
participants. Participants will 
mail accelerometers back to the 
UMN in postage paid envelope.  
 
Anthropometrics will be 
collected via self-report 
6.2.1 Screening 
Evaluation 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
Additional detail added regarding 
options for participants to decline 
taking part in session activities, 
especially group discussions, in 
response to UMN IRB 
RNI00004599. 
7. 3 Methods & Timing 
for Assessing, Recording, 
and Analyzing Safety 
parameters 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
Adaptations of Working Alliance 
Inventory (WAI) and Telehealth 
Usability Questionnaire added at 
Week 9. 
9.5 Outcomes 
6.1 Schedule of 
Evaluations 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
A secondary analysis in response 
to COVID-19 will be conducted. 
 
Remote screening and 
intervention delivery will be 
treated as a distinct “site” within 
the analysis.   
9.6 Analysis 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
June 2020 
 
The first baseline evaluation will 
take place up to 90 days after the 
initial screen described above. 
Was previously 150 days.  
6.2.1 Screening evaluation UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 

Page 12 V10 February 2021 
 
 
V9 
June 2020 
 
Updated monitoring section to 
include a description of remote 
monitoring by Westat 
10.3.6 Monitoring 
UMN IRB 
NCCIH 
NCCIH: 
9/2/2020 
IRB: 
9/28/2020 
V9 
Oct 2020 
 
Covid impact questionnaire may 
be asked during the screening 
process. This question was 
previously approved and may be 
collected post-intervention 
6.1 Schedule of 
Evaluations 
UMN IRB 
IRB: 
11/4/2020 
V10 
Feb 2021 
 
Changed Feinstein to Folstein (in 
reference to the MMSE) – 
Feinstein was a typo. 
4.2. Eligibility Criteria 
UMN IRB 
IRB:3/1/2021 
V10 
Feb 2021 
 
BL2 can occur 7-28 business days 
after BL1 to allow additional time 
for mailing, receiving and 
processing accelerometers.  
6.2.1 Screening 
Evaluation 
UMN IRB 
IRB:3/1/2021 
V10 
Feb 2021 
 
Enrolled individuals will 
commence their allocated 
intervention up to 14 business 
days post randomization. 
6.2.2 Enrollment, Baseline 
& Randomization 
UMN IRB 
IRB:3/1/2021 
V10 
Feb 2021 
 
Added Oliver Ang and Don 
Thorpe. These UMN staff were 
approved by the IRB previously 
to work on the study.Protocol 
updated to include their names.  
Updated contact information for 
research staff   
Study Team Roster 
UMN IRB 
IRB:3/1/2021 
. 
 
 

Page 13 V10 February 2021 
 
 
TABLE OF CONTENTS 
 
 
 
 
 
 
 
 
TOOL REVISION HISTORY ............................................................................................................................ 2 
ABBREVIATIONS/DEFINITIONS................................................................................................................. 14 
STUDY TEAM ROSTER ................................................................................................................................. 15 
PARTICIPATING STUDY SITES (R33) ......................................................................................................... 18 
1. 
STUDY OBJECTIVES ......................................................................................................................... 19 
     1.1  Overview .............................................................................................................................................. 19 
     1.2 Primary Objective ................................................................................................................................. 20 
     1.3  Secondary Objectives ............................................................................................................................ 20 
2. 
BACKGROUND AND RATIONALE ................................................................................................. 21 
     2.1 Background on Condition, Disease, or Other Primary Study Focus ..................................................... 21 
     2.2 Study Rationale ..................................................................................................................................... 22 
3. 
STUDY DESIGN .................................................................................................................................. 24 
     3.1 Overview ............................................................................................................................................... 25 
4. 
SELECTION AND ENROLLMENT OF PARTICIPANTS................................................................. 25 
     4.1 Definition of “Participants” ................................................................................................................... 25 
     4.2 Eligibility Criteria .................................................................................................................................. 26 
     4.3 Study Enrollment Procedures ................................................................................................................ 28 
5. 
STUDY INTERVENTIONS ................................................................................................................. 31 
     5.1 Interventions, Administration, and Duration ......................................................................................... 31 
     5.2 Handling of Study Interventions............................................................................................................ 33 
     5.3 Concomitant Interventions .................................................................................................................... 34 
     5.4 Adherence Assessment .......................................................................................................................... 34 
6. 
STUDY PROCEDURES ....................................................................................................................... 34 
     6.1 Schedule of Evaluations ........................................................................................................................ 35 
     6.2 Description of Evaluations .................................................................................................................... 36 
7. 
SAFETY ASSESSMENTS ................................................................................................................... 39 
     7.1 Expected adverse events by intervention ............................................................................................... 39 
     7.2 Specification of Safety Parameters ........................................................................................................ 40 
     7.3 Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ............................. 40 
     7.4 Adverse Events and Serious Adverse Events ........................................................................................ 41 
     7.5 Reporting Procedures ............................................................................................................................ 43 

Page 14 V10 February 2021 
 
 
     7.6 Safety Monitoring.................................................................................................................................. 44 
8. 
INTERVENTION DISCONTINUATION ............................................................................................ 45 
      8.1 Investigator Initiated Discontinuation ................................................................................................... 45 
      8.2 Participant Initiated Discontinuation ..................................................................................................... 45 
9. 
STATISTICAL CONSIDERATIONS .................................................................................................. 45 
      9.1 General Design Issues ........................................................................................................................... 45 
       9.2 Sample Size and Randomization ......................................................................................................................... 46 
      9.3 Definition of Populations....................................................................................................................... 46 
     9.4 Interim analyses and Stopping Rules..................................................................................................... 46 
     9.5 Outcomes............................................................................................................................................... 47 
     9.6 Data Analyses ........................................................................................................................................ 49 
10. 
DATA COLLECTION AND QUALITY ASSURANCE ..................................................................... 51 
    10.1 Data Collection Forms........................................................................................................................... 51 
    10.2 Data Management ................................................................................................................................. 53 
    10.3 Quality Assurance and Quality Control................................................................................................. 53 
11. 
PARTICIPANT RIGHTS AND CONFIDENTIALITY ....................................................................... 56 
    11.1 Institutional Review Board (IRB) Review ............................................................................................ 56 
    11.2 Informed Consent Forms ....................................................................................................................... 56 
    11.3 Participant Confidentiality..................................................................................................................... 56 
    11.4 Study Discontinuation ........................................................................................................................... 56 
12. 
COMMITTEES ..................................................................................................................................... 57 
13. 
PUBLICATION OF RESEARCH FINDINGS ..................................................................................... 57 
14. 
REFERENCES ...................................................................................................................................... 58 
 
 
ABBREVIATIONS/DEFINITIONS 
• UMN/University of Minnesota 
• YMCA GTC/YMCA Greater Twin Cities 
• RCT/Randomized Controlled Trial 
• MBI/Mindfulness Based Intervention 
• MBSR/Mindfulness Based Stress Reduction 
• PRECIS/Pragmatic-Explanatory Continuum Indicator Summary 
• RE-AIM/Reach, Effectiveness, Adoption, Implementation, and Maintenance 
• MMSE/Mini-mental status score 
• W/ Week 
• MVPA/Moderate Vigorous Physical Activity 
• SA/Sedentary Activity 
• SEE/Self-efficacy for exercise 

Page 15 V10 February 2021 
 
 
• OEE_2/ Outcome Expectations for Exercise-2 
• CPM/Counts per minute 
• PAR-Q/ Physical Activity Readiness Questionnaire 
• MAAS/Mindful Attention Awareness Scale 
• FMI/Freiberg Mindfulness Inventory 
• IPAQ-International Physical Activity Questionnaire 
• REDCap/Research Electronic Data Capture 
• AE/Adverse Event 
• SAE/Serious Adverse Event 
• MET/ Metabolic Equivalent of Task 
• USPS/ United States Postal Service 
• BL/Baseline 
• BL1/Baseline visit 1 
• BL2/Baseline visit 2 
• DOB/Date of Birth 
• HSR/Human Subjects Research 
• TUQ/Telehealth Usability Questionnaire 
• WAI/Working Alliance Inventory 
• e-Consent/electronic consent 
• W0/ Week 0 
 
STUDY TEAM ROSTER 
Principal Investigator 
Roni Evans PhD, DC, MS 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9004 
Email:  evans972@umn.edu 
 
Co-Investigators 
Gert Bronfort, PhD, DC  
Co-Investigator 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9005 
Email:  bronf003@umn.edu 
 
John Connett, PhD  
Co-Investigator 
Biostatistics, Epidemiology and Research Design (BERD) Clinical and Translational Science Institute 
University of Minnesota 
717 Delaware Street SE, Minneapolis, MN 55455  
Phone: (612) 626-9010 
Email:  john-c@umn.edu 
 
Zan Gao, PhD  
Co-Investigator 
School of Kinesiology 
University of Minnesota, Cooke Hall, 207 
1900 University Ave SE, Minneapolis, MN 55455  

Page 16 V10 February 2021 
 
 
Phone: (612) 626-4639 
Email:  gaoz@umn.edu 
 
Linda Hanson DC, MS, CCRP  
Co-Investigator/Project Director  
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9009 
Email:  hans4236@umn.edu 
 
Mary Jo Kreitzer, PhD, RN, FAAN  
Co-Investigator 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C510  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 625-3977 
FAX:  (612) 626-5280 
Email:  kreit003@umn.edu 
 
Brent Leininger, DC, MS  
Co-Investigator 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9007 
Email:  lein0122@umn.edu 
 
Craig Schulz DC, MS 
Co-Investigator/Data Manager 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C504 
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9006 
Email:  schu1385@umn.edu 
 
Alex Haley J.D., MBA 
Mindfulness Lead/Facilitator Trainer 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C592  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 624-9459 
Email:  haley045@umn.edu 
 
Douglas Kennedy, PhD 
Mindfulness Expert/Education Specialist/Recruitment Liaison 
Earl E. Bakken Center for Spirituality & Healing  
University of Minnesota, Mayo Memorial Building, C592  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612)-625-6946 
Email:  kenne829@umn.edu 
 
 
 
 
 

Page 17 V10 February 2021 
 
 
Research Staff 
 
Oliver Ang PT, MCISc 
Earl E. Bakken Center for Spirituality and Healing 
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 626-6477 
Email: ang00005@umn.edu 
 
John Jodzio, BA  
Research Administrator 
Earl E. Bakken Center for Spirituality and Healing 
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 301-9006 
Email:  jodz0001@umn.edu 
 
Amy McGarness 
Program Facilitator/Project Coordinator 
North Community Harold Mezile YMCA 
1711 W Broadway Ave, Minneapolis, MN 55411 
Phone: (952) -230- 6681  
Email: amy.mcgarness@ymcamn.org 
 
Heidi Mendenhall, DC, MS 
Research Fellow/Research Assistant 
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 626-6477 
Email: hmendenh@umn.edu 
 
Don Thorpe, DC 
Research Fellow/Post-Doc Associate 
University of Minnesota, Mayo Memorial Building, C504  
420 Delaware Street, Minneapolis, MN 55414 
Phone: (612) 626-6477 
Email: hmendenh@umn.edu 
 
Diane Schroeder 
Program Facilitator 
YMCA Greater Twin Cities 
Phone: 612-669-8610 
Email: Diane.Schroeder@ymcamn.org  
 
Kathy Young 
Program Facilitator 
YMCA Greater Twin Cities 
Phone: 651-894-4741 
Email: youn1887@umn.edu 
 
Chandra Ziegler 
Program Facilitator 
YMCA Twin Cities/St. Paul Midway YMCA 
1761 University Ave, St. Paul, MN 55104 
Phone: (612) 230-7 629  

Page 18 V10 February 2021 
 
 
Email: chandra.ziegler@ymcamn.org 
 
PARTICIPATING STUDY SITES (R33)  
 
YMCA St. Paul Midway 
 
1761 University Ave, St. Paul, MN 55104  
Phone: (651) 646-4557 
Website: https://www.ymcamn.org/locations/st_paul_midway_ymca 
 
YMCA Southdale 
7355 York Avenue South, Edina, MN 55435  
Phone: (952) 835-2567 
Website: https://www.ymcamn.org/locations/southdale_ymca 
 
 
YMCA Burnsville 
13850 Portland Avenue, Burnsville, MN 55337 
Phone: (952) 898-9622 
Website: https://www.ymcamn.org/locations/burnsville_ymca 
 
 
YMCA Cora McCorvey 
1015 4th Avenue North, Minneapolis, MN 55405 
Phone: (612) 230-3987 
Website: https://www.ymcamn.org/locations/cora_mccorvey_ymca 
 
 
YMCA Maplewood 
2100 White Bear Avenue, Maplewood, MN 55109 
Phone: (651) 747-0922 
Website: https://www.ymcamn.org/locations/maplewood_community_center 
 
YMCA Twin Cities 
651 Nicollet Mall #500, Minneapolis, MN 55402 
https://www.ymcamn.org/ 
 
Due to the COVID-19 pandemic, all in-person study sessions (i.e., screening activities, intervention and follow-up visits) 
will be conducted remotely. Participants will be recruited through all YMCA Twin Cities locations. Individual YMCA 
locations are not listed, instead the main office (YMCA Twin Cities) is listed.  

Page 19 V10 February 2021 
 
 
PRÉCIS 
Study Title 
Mindful Movement for Physical Activity and Wellbeing in Older Adults: A Community Based Randomized 
Hybrid Effectiveness-Implementation Study 
 
Objectives 
The broad long-term objective of this research is to optimize physical activity levels in middle to older age 
adults (>50 years) using an integrated mindfulness and behavioral approach, which can be scaled for 
dissemination nationwide. We will work with the YMCA Greater Twin Cities, a community based 
organization. To overcome the problematic lag between research discovery and translation, we will use an 
innovative hybrid effectiveness-implementation design.  
 
Design and Outcomes 
We will conduct a Randomized Controlled Trial (RCT, n=182) to determine the relative effectiveness of two 
educational programs, Mindful Movement versus Keys to Health & Wellbeing (Aim 1) by assessing the 
following: 
• Primary physical activity outcome: time spent per week in ≥ 10 minute bouts of moderate-
vigorous physical activity (MVPA) at 9 weeks; 
• Secondary physical activity outcomes: time spent per week in ≥ 10 minute bouts of MVPA at 26 and 52 
weeks; time spent per week in MVPA and sedentary activity; and steps per day at 9, 26, and 52 weeks. 
• Secondary self-report measures: quality of life, exercise self-efficacy and expectations, mindfulness, 
wellbeing, bodily pain, physical activity, social connectedness and assurance, intervention satisfaction, 
and adverse events at 9, 26, and 52 weeks. 
 
To facilitate interpretation of the RCT results and provide resources for translation and sustainability, we will 
collect and describe complete contextual data within the RCT at the participant, facility and organizational 
levels and create a web-based implementation toolkit that can be used by other sites (Aim 2). 
 
Interventions and Duration 
The duration of the interventions is 8 weeks. One additional week, a pre-intervention session, (i.e., Week 0) is 
included to introduce & orient participants to the remote Zoom, group environment. The interventions are group 
educational programs, Mindful Movement (experimental intervention) versus Keys to Health & Wellbeing 
(control intervention), both facilitated by YMCA staff facilitators. 
 
Sample Size and Population 
We will enroll 182 participants 50 years of age and older.  
 
1. STUDY OBJECTIVES 
1.1 
Overview 
Physical inactivity is a significant public health problem associated with increased risk of disabling medical 
conditions, chronic disease and mortality, as well as diminished wellbeing.1-3 Despite recommendations to 
engage in at least 150 minutes per week of moderate to vigorous physical activity (MVPA), most older adults 
do not.4,5 There is also growing attention on the detrimental health effects of sedentary, very low energy 
activities.6-8 There are many theoretical mechanisms underlying older adults’ physical and sedentary behaviors, 

Page 20 V10 February 2021 
 
 
which when considered in aggregate relate to individuals’ capacity, motivation, and opportunity.9 Specific 
theory based behavioral strategies, especially those that are self-regulatory and provide social support, have 
demonstrated effectiveness in positively affecting health and activity behaviors.7,10,11 Emerging evidence also 
suggests mindfulness based interventions (MBI), incorporating mindfulness meditation, can be helpful for 
addressing challenges related to initiating and engaging in health behaviors12-14 including physical activity.15,16 
With a focus on non-judgmental, present-oriented awareness, MBIs can facilitate self-regulation of attention on 
immediate experiences, thoughts and emotions with an orientation of openness, curiosity, and acceptance.17 
MBIs may also help older adults’ navigate common negative exercise-related experiences, expectations, and 
beliefs. However, there is a void in research examining MBIs for health behaviors including physical and 
sedentary activities. 
 
The broad long-term objective of this research is to optimize physical activity levels in middle to older age 
adults (>50 years) through Mindful Movement, an integrated mindfulness and behavioral approach, which can 
be scaled for dissemination nationwide. We will work with the YMCA Greater Twin Cities, a community 
based organization, which provides opportunities to “build healthy spirit, mind, and body for all” and has made 
healthy aging a strategic priority. Together, with a multi-disciplinary team, we will refine and test a multi-level 
“Mindful Movement” program comprised of mindfulness practices and evidence based behavioral strategies to 
facilitate activity related behaviors. To overcome the problematic lag between research discovery and 
translation, we will use an innovative hybrid effectiveness- implementation design18 comparing Mindful 
Movement to a Keys to Health & Wellbeing education program adapted from previous research.19 
 
1.2 
Primary Objective 
Aim 1: To determine the relative effectiveness of 8 weeks of Mindful Movement versus Keys to Health & 
Wellbeing in a Randomized Controlled Trial (RCT, n=182) as measured by changes in primary physical 
activity outcome: time spent per week in ≥10 minute bouts of moderate-vigorous physical activity (MVPA) at 
9 weeks. 
 
1.3  
Secondary Objectives 
Aim 2: To determine the relative effectiveness of the two interventions as measured by changes in:  
a. Secondary physical activity outcomes: time spent per week in ≥ 10 minute bouts of MVPA at 26 and 52 
weeks; time spent per week in MVPA and sedentary activity; and steps per day at 9, 26, and 52 weeks. 
b. Secondary self-report measures: quality of life, exercise self-efficacy and expectations, mindfulness, 
wellbeing, bodily pain, physical activity, social connectedness and assurance, intervention satisfaction, and 
adverse events at 9, 26, and 52 weeks. 
  
 
Aim 3: To facilitate interpretation of RCT results and provide resources for translation and sustainability by: 
 
a. Collecting contextual information to inform eventual broad scale intervention implementation. This includes 
assessment of participants (including follow up rates for self-reported outcomes, and barriers and facilitators to 
intervention and study participation); facility (including staff adherence to recruitment and intervention 
protocols; confidence in protocol and intervention delivery; perceived barriers and facilitators to intervention 
and study implementation); and organizational (including leadership views regarding intervention and study 
relevance, practicality, affordability, and acceptability; intervention related costs). 
b. Creating a web-based implementation toolkit that can be used by other sites. 
 

Page 21 V10 February 2021 
 
 
 
1.1 
Hypotheses 
Our primary hypothesis is that there will be a significant advantage (>56 minutes) in terms of the primary 
outcome measure, weekly minutes spent in >10 minute bouts of MVPA for Mindful Movement over the Keys 
to Health & Wellbeing. 
 
Our secondary hypotheses are: 
• There will be a significant advantages of Mindful Movement over Keys to Health & Wellbeing in terms of 
the secondary objective outcome measures of time spent per week in ≥ 10 minute bouts of MVPA; time spent 
per week in MVPA and sedentary activity; and steps per day 
• There will be significant advantages of Mindful Movement over Keys to Health & Wellbeing in terms of the 
secondary self-reported outcomes: quality of life, exercise self-efficacy and expectations, mindfulness, 
wellbeing, bodily pain and physical activity 
• There will be no significant advantages of Mindful Movement over Keys to Health & Wellbeing in 
terms of the secondary self-reported outcomes of social connectedness and assurance, and 
intervention satisfaction 
 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
This project addresses the significant challenge of engaging middle to older age adults in physical 
activity. By using a rigorous hybrid randomized effectiveness-implementation design, we will test a ‘Mindful 
Movement’ program with our collaborators at the YMCA Greater Twin Cities (YMCA GTC), the third largest 
YMCA in the United States. The YMCA’s strategic priorities include improving wellbeing through all stages 
of life and developing socially responsible communities by embracing diversity and inclusion. With a 
membership of more than 300,000 locally and 22 million nationally and the ability to attract non- members, the 
YMCA has great reach. Furthermore, the YMCA’s commitment to providing geographically and financially 
accessible resources and facilities greatly enhances the potential for this project to positively impact the 
physical activity, health, and wellbeing of a large and diverse population. 
 
Physical inactivity is a global health concern with profound consequences. Physical inactivity has reached 
pandemic proportions,20,21 and is defined as a level insufficient to meet current recommendations for at least 
some health benefits ( 3.3 METs: 150 minutes of  moderate aerobic physical activity per week OR  6.0 METs: 
75 minutes of vigorous aerobic physical activity per week OR an equivalent combination of both, with bouts of 
activity at least 10 minutes in duration). With nearly a third of the world’s population failing to meet minimal 
recommended physical activity levels,22 the health and economic consequences are sobering. The negative 
impacts of physical inactivity approximate those of smoking and obesity,21 and it has been estimated that up to 
10% of all deaths from non- communicable diseases are due to insufficient physical activity.21  In the US, costs 
attributable to physical inactivity were $500 billion in 2003 and estimated to exceed $700 billion in 2008.23 
Conversely, there are many positive benefits of physical activity, including reduced risk of chronic diseases and 
falls, and improved function, quality of life, and wellbeing.20,21  It has been estimated that inactive American 
adults could gain up to 4 added years from age 50 by becoming active21,24,25 and that even modest activity (e.g. 
15-30 minutes per day of brisk walking) would confer health benefits.1,20,26 

Page 22 V10 February 2021 
 
 
 
Sedentary activities carry important health risks independent of physical activity. While substantial 
attention has been paid to physical inactivity, it is only relatively recently that focus has been placed on 
sedentary behaviors, defined as engagement in very low energy activities (<1.5 METS) including sitting or 
reclining at work, home or during commuting and leisure times. Time spent sedentary has been associated with 
higher risk of physical frailty,6 metabolic syndromes, and mortality.7,8 Noteworthy is that participation in high 
levels of MVPA fails to fully mitigate risks of prolonged sedentariness.6,7 These studies suggest that 
interventions should not only target increased physical activity but also concomitant reductions in sedentary 
behaviors. 
 
Physical inactivity and sedentary behavior is a major concern for middle to older age adults. With the 
U.S. older adult population rapidly growing, increased attention is being paid to middle to older age adults’ 
physical and sedentary behaviors.27 Physical activity recommendations for older individuals are the same as for 
their younger counterparts.1,20,26 A total of 150 minutes per week in MVPA is recommended for some health 
benefits, and 300 minutes per week is recommended for greater health benefits.28 Regular walking is among the 
most common physical activities engaged by older adults, and generally meets the criteria for moderate 
intensity physical activity.29 Recent evidence shows the majority of middle age to older adults fall alarmingly 
short of recommendations for physical and sedentary activities. In the recently published work by Hooker et al,4 
75-90% of time was spent engaged in sedentary behavior, 10-23% in light physical activity, and only 0-2% in 
MVPA. Only 3 to 12% of participants reached > 150 min/week using the recommended 10 minute bout 
criterion.4 
 
Qualitative studies have found that many older adults associate exercise with potentially negative effects.30 
Further, some carry the belief that health declines are inevitable, leading to less investment in preventive 
behaviors, and subsequent health declines.31 Importantly, older adults with multiple chronic conditions (a 
common occurrence with advancing age32) are at higher risk for negative perceptions about aging, and sedentary 
behavior. These perceptions contrast with recommendations for exercise (including aerobic forms) irrespective 
of age, comorbidity, pain severity, and disability.33 
 
2.2 
Study Rationale 
There is evidence to support several behavioral strategies for optimizing physical activity. Initiating and 
sustaining engagement in physical activity is complex, and is influenced by many factors.9 One model of 
behavior useful for understanding physical and sedentary activities is the COM-B model, which addresses 
capabilities, opportunities, and motivations related to behavior. Capability refers to the abilities required to 
enact a behavior and opportunity refers to the physical and social environment that facilitates the behavior. 
Motivations include reflective mechanisms (e.g. beliefs about what is good and bad, conscious intentions, 
decisions, and plans) and automatic mechanisms (e.g. emotional responses, desires, impulses, and habits 
resulting from associative learning and physiological states) that facilitate or inhibit behaviors.9 
 
Systematic reviews of behavioral interventions for promoting changes in physical activity have found evidence 
for social support and the use of well-described behavior techniques, particularly those focused on self- 
regulation (e.g. goal setting, prompting, self-monitoring, providing feedback on performance, and goal 
review).10,34 Of note is the recommendation that individual behavior techniques be combined as part of a 
coherent intervention in which theory, strategies, and goals are aligned.9,10,35 
 

Page 23 V10 February 2021 
 
 
Research is beginning to emerge using this approach in older adult populations. In the RCT by Burke et al 
(n=478),36 a 6 month, home based intervention which included an informational booklet, goal setting, e-mail 
and phone reminders, resulted in significant improvement in self- reported physical activity in 60-70 year old 
participants. A recent cluster RCT of nearly 300 individuals 60-75 years of age37 tested a program focused on 
key behavioral strategies (goal- setting, self-monitoring, building self-efficacy social support, barrier and 
relapse prevention, and habit building) to encourage walking. A significant increase compared to the control 
was observed in daily steps and 10 minute bouts of MVPA at 3 and 12 months, with no adverse events. These 
studies suggest that behavioral strategies to enhance physical activity are appropriate for use in older adults, 
and warrant further investigation. 
 
Mindfulness based interventions (MBIs) are among the top five commonly used complementary and 
integrative health (CIH) practices in the U.S.38 Mindfulness Based Stress Reduction (MBSR) is the most 
popular and formalized of the mindfulness programs, stemming from Jon Kabat-Zinn’s early work that 
introduced systematic, secular training in mindfulness.17,39 MBSR and many MBIs, are offered as group format 
interventions focused on education, training, practice and social support in mindfulness meditation. 
Mindfulness is considered a ‘meta-cognitive’ skill (cognition about one’s cognition)40 which has been 
described as “the awareness that arises by paying attention, on purpose, and non-judgmentally, to present 
moment experience”.41  Mindfulness can be developed through meditation training and practice aimed at 
enhancing attention regulation, body awareness, emotional regulation, and shifts in self-perception,42 all 
potentially important and useful skills for engaging in healthy behaviors. 
 
The number of studies investigating MBIs is rapidly increasing and there is growing evidence for MBIs’ 
synergistic neurobiological and behavioral mechanisms. This includes mechanistic studies demonstrating the 
ability of MBIs to positively affect brain regions and functions necessary for regulating attention, emotion 
and pain, as well as body awareness and self-perception.42,43 While a recent evidence map of 81 systematic 
reviews of MBIs44 has found generally positive clinical outcomes for a range of health issues, there is a 
scarcity of research focused on investigating the effectiveness of MBIs for enhancing optimal health 
behaviors. 
 
However, the little research that has been performed is promising. Emerging evidence suggests MBIs 
incorporating mindfulness meditation, can be helpful for addressing challenges related to initiating and 
engaging in health behaviors.12,13,45 This includes promising work incorporating MBIs to enhance physical 
activity.15,16 A small randomized controlled trial (RCT) of 19-64 year olds (n=62) found that 4, 2 hour MBI 
workshops resulted in significant increases in self-reported physical activity at 6 months compared to controls. 
Another recent RCT of 30-50 year olds15 (n=138), found that 9, 90 minute sessions of mindfulness combined 
with Acceptance and Commitment Therapy improved physical activity self-efficacy and discomfort acceptance 
compared to feedback alone. And while no studies have yet examined MBIs for encouraging physical activity 
behaviors for mid to older age adults exclusively, preliminary qualitative research found that older adults 
(mean age 74 years) with low back pain who participated in an 8 week MBSR program, perceived beneficial 
changes in body awareness resulting in behavior change.46 Overall, the encouraging results of these studies, 
coupled with the growing evidence base regarding MBIs neurobiological and behavioral mechanisms, suggest 
it is the right time for rigorous studies coupling mindfulness approaches with evidence-based behavioral 
strategies for ameliorating physical inactivity and sedentary behaviors in mid to older age adults. 
 
There are several theoretical mechanisms by which mindfulness skills may improve physical activity. 
Barriers to physical activity often include entrenched ideas, including beliefs that exercise is painful and even 
physically harmful.47 In practicing movement with mindfulness, participants learn to intentionally pay 

Page 24 V10 February 2021 
 
 
attention (attention regulation) to their physical 
sensations (increasing body awareness), with an 
attitude of friendliness and curiosity. This can lead to 
shifts in perception in which MBI participants are 
surprised and even pleased as enjoyable sensations of 
movement come to the foreground of their attention, 
and 
discomfort or pain shifts to the background. Such shifts 
could result in shaping behaviors or actions towards 
physical activity engagement rather than avoidance. 
The 
cognitive flexibility afforded by mindfulness may also 
pave 
the way for the application of other behavioral skills, 
including value based goal-setting and action planning. 
Non- judgmental awareness may aid in relapse 
management, where relapses are viewed with 
neutrality and compassion.47 Further, coupling 
muscular activity with an internally directed focus can 
facilitate interoceptive attention to bodily 
sensations.48,49 50-52 This suggests that mindfulness techniques are indeed well suited to integrate with all types 
of physical activity, with potential reciprocal effects (e.g. mindfulness can facilitate activity, and activity can 
facilitate mindfulness).12 
 
MBIs could also lead to increased physical activity through attenuation of other common barriers including 
avoidant impulses and habitual thinking which prevent initiation, engagement, and maintenance.47,53,54 By 
encouraging individuals to become aware, they can open to the possibility that allowing such habits to dictate 
behavior is contrary to wellbeing. Further, in facilitating a time interval where one is able to observe thoughts, 
feelings and sensations non-judgmentally, as opposed to negatively, mindfulness can lead to the formation of 
different appraisals and behavioral choices (e.g. engaging in activity versus avoiding it, etc).13 Thus, through 
practice in mindfulness, mid to older age adults can moderate activities appropriate for themselves. They can 
also actively respond to rather than automatically react to the emotions (emotional regulation) or thoughts 
that may arise when confronted with barriers to physical activity engagement. Overall, our underlying 
theoretical framework for the Mindful Movement Program can be summarized using the COM-B model.9 By 
providing education, training and practice in mindfulness meditation, and evidence-based behavioral strategies, 
we will enhance mid to older age adults’ capabilities and skills required to engage in healthy physical activity 
behaviors. These will serve to activate positive motivations including those that are reflective (e.g. beliefs, 
conscious intentions, decisions, and plans) and automatic (e.g. emotional responses, desires, impulses, and 
habits) and inhibit negative ones. Importantly, by integrating the program within the YMCA, a community 
based organization that offers geographically and financially accessible resources and facilities in socially 
supportive environments, we will provide mid-older age adults from all backgrounds opportunities to facilitate 
physical activity related behaviors, and enhance their overall health and wellbeing. 
 
3. STUDY DESIGN 
To speed the translation of research to practice there has been increasing interest in study designs and strategies 
that work to balance methodological rigor with generalizability. This includes the emergence of hybrid 
effectiveness-implementation designs,18 and other frameworks,55 which blend rigorous clinical research 
approaches alongside implementation research methods to facilitate adoption by providers and systems. 
 

Page 25 V10 February 2021 
 
 
We will use a hybrid randomized design which simultaneously tests the intervention and the implementation 
using rigorous methods to provide valid estimates.18 To facilitate the future implementation of the Mindful 
Movement intervention to YMCA and other community based settings, we used the “Reach, Effectiveness, 
Adoption, Implementation and Maintenance” RE- AIM framework to inform the design.55  
 
3.1 Overview 
This is a randomized controlled trial. It uses a hybrid effectiveness-implementation approach and is informed 
by the RE-AIM framework, to facilitate intervention uptake and sustainability.18,55 This study has the following 
aims: 
 
Aim 1. To determine the relative effectiveness of 8 weeks of Mindful Movement versus Keys to Health & 
Wellbeing (n=182) as measured by changes in primary physical activity outcome: time spent per week in ≥10 
minute bouts of moderate-vigorous physical activity (MVPA) at 9 weeks. 
 
Aim 2. To determine the relative effectiveness of the two interventions as measured by changes in:  
a. Secondary physical activity outcomes: time spent per week in ≥ 10 minute bouts of MVPA at 26 and 52 
weeks; time spent per week in MVPA and sedentary activity; and steps per day at 9, 26, and 52 weeks. 
b. Secondary self-report measures: quality of life, exercise self-efficacy and expectations, mindfulness, 
wellbeing, bodily pain, physical activity, social connectedness and assurance, intervention satisfaction, 
and adverse events at 9, 26, and 52 weeks. 
 
Aim 3. To facilitate interpretation of RCT results and provide resources for translation and sustainability by: 
 
a. Collecting contextual information to inform eventual broad scale intervention implementation. This 
includes assessment of participants (including follow up rates for self-reported outcomes, and barriers 
and facilitators to intervention and study participation); facility (including staff adherence to recruitment 
and intervention protocols; confidence in protocol and intervention delivery; perceived barriers and 
facilitators to intervention and study implementation); and organizational (including leadership views 
regarding intervention and study relevance, practicality, affordability, and acceptability; intervention 
related costs). 
b. Creating a web-based implementation toolkit that can be used by other sites. 
 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 
Definition of “Participants” 
The nature of a hybrid effectiveness/implementation design warrants participation of subjects at different levels. 
Participant level. Participants will be randomly allocated to participate in experimental (Mindful 
Movement) or control (Keys to Health & Wellbeing) interventions, and will take part in baseline 
and post- intervention quantitative and qualitative data collection activities. 
Facility level. These individuals include those who work at the YMCA (e.g. staff), but are not in 
leadership positions. These individuals will be asked to volunteer to participate in qualitative data 
collection to provide important contextual information that could affect implementation of the 

Page 26 V10 February 2021 
 
 
interventions in the long term. 
Organizational level. These individuals have the potential to influence YMCA’s strategic planning (e.g. 
hold leadership positions). Similar to the facility level subjects, these individuals will be asked to 
volunteer to participate in qualitative data collection to provide important contextual information that 
could affect implementation of the interventions in the long term. 
 
 
4.2 Eligibility Criteria 
All participant level subjects taking part in the RCT must meet all of the inclusion criteria and none of the 
exclusion criteria by the time of enrollment (randomization at or following BL2) to participate in this study.  
 
4.2.1 Inclusion Criteria 
Inclusion criteria are summarized below; see manual of operations for further operationalization: 
• ≥ 50 years of age (as of date of initial screen, confirmed with date of birth). 
• Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between BL1 and 
BL2. 
• Self-report of <140 minutes of MVPA per week (in 10 minute bouts, in the past 3 months at initial 
screen and BL1) AND accelerometer recorded <100 minutes of MVPA (in 10 minute bouts, between 
BL1 and BL2). 
• Independent self-ambulation (without assistance of another individual; can use mobility aid such as a 
cane, walker, scooter or wheelchair). 
• Provides informed consent (signed consent form and demonstrated understanding using Modified 
Deaconess Questionnaire). 
• Folstein Mini Mental Status Exam (MMSE) ≥ 24 for those with suspected cognitive decline. 
 
 
Additionally, the following describes inclusion criteria for the other subject levels who provide important 
contextual information required as part of the hybrid effectiveness/implementation design and RE-AIM 
framework. 
• 
Potential participant level subjects must be 50 years of age and older and willing to participate in 
qualitative data collection. 
• 
Facility level subjects must work at the YMCA (e.g. staff), but are not in leadership positions, and 
willing to participate in qualitative data collection. 
• 
Organizational level subjects are defined as individuals at the YMCA who influence the strategic 
planning of the organization (e.g. hold leadership positions) and willing to participate in qualitative 
data collection. 
 
4.2.2 Exclusion Criteria 
Exclusion criteria are summarized below; see manual of operations for further operationalization: 
• Pregnancy (self-report of current pregnancy or trying to get pregnant) 

Page 27 V10 February 2021 
 
 
• Unwilling or unable to participate in study activities (not able and willing to attend baseline study 
visits; not able and willing to wear the accelerometer daily for at least 10 hours per day on 7 days; not 
able and willing to complete self-report questionnaires unassisted, using electronic or paper formats, 
[includes English literacy]; cannot commit to attending >70% of intervention sessions via 
videoconference*) 
• Current or upcoming participation in educational programs similar to those under study 
• Medical restrictions to increasing MVPA (Participant self-report AND health care provider does 
not provide clearance to participate)** 
• Terminal illness 
• Contraindications to mindfulness practices: 
o Serious mental health or brain conditions (bipolar disorder, schizophrenia, psychotic disorder or 
problems, Alzheimer’s, dementia, major depressive disorder, major anxiety disorders). Self-report 
of diagnosis by a health provider AND health care provider does not provide clearance to 
participate** 
o Suicidality (score of > 2 on the suicidal ideation screen from the Quick Inventory of Depressive 
Symptomatology-Self Report (QIDS-SR)56 
o Substance abuse (self-report of substance abuse at time of screening as measured by affirmative 
responses to screening questions of drinking more alcohol or using more drugs than intended in 
the past 6 months AND feeling the need to cut down on alcohol use or drugs) 
o PTSD (self-report of diagnosis of PTSD AND health care provider does not provide clearance to 
participate)** 
o Seizure disorder. Self-report of diagnosis by a health provider AND health care provider does not 
provide clearance to participate** 
 
*Participants can participate even if they do not have the appropriate electronic hardware and/or internet 
access. These individuals will be identified during screening and provided the necessary technology resources 
(e.g. computer tablet, mobile hot spot device, etc.). Electronic devices will be formatted by UMN staff to allow 
participants to participate in screening activities, the study interventions, and data collection. Enrolled 
participants can keep this equipment. Participants who disqualify during the screening process will be asked to 
send the equipment back to the university in a postage-paid package.  
 
To reduce potentially negative impacts on recruitment we will only send devices/tablets to individuals who have 
completed a thorough initial screening; this will minimize the amount of mailing back and forth of devices since 
the majority of individuals will likely qualify at this point. Additionally, the time window between initial 
screening and baseline 1 is sufficiently long enough (90 days) to accommodate shipping and returns.  
 
We feel there is an advantage of having potential participants try using Zoom prior to randomization; by 
experiencing the Zoom environment they can make better informed decisions regarding participation. In doing 
so, we anticipate increased intervention engagement and fewer withdrawals.    
 
 

Page 28 V10 February 2021 
 
 
** Healthcare provider clearance: participants who may have contraindications to mindfulness practices or 
medical restrictions to increasing MVPA (as determined by assessment of inclusion/exclusion criteria during 
screening) need written clearance from their medical provider to participate in the study. The medical waiver 
includes information about the study purpose, the funding agency, a list of potential risks and contact 
information for the study team. Participants are instructed to review the waiver with their medical team and 
return the signed waiver (by mail, fax or scanned) to the study team prior to randomization. Medical waivers are 
secured in the participant’s research file. Those who are not able to obtain this necessary clearance cannot 
participate. 
 
4.3 
Study Enrollment Procedures 
4.3.1 Identification of Candidate Participants 
Participants will self-identify in response to various solicitation methods (see below). Private medical or 
protected records will not be accessed for screening. Participants will be recruited from the Twin Cities and 
surrounding metropolitan communities.  
 
4.3.2 Recruitment of Candidate Participants 
Participant level subjects: Consistent with normal YMCA practices and to enhance our reach to a diverse study 
population, we will recruit from all YMCA sites in the Twin Cities, as well as in the general community. We will 
reach Twin Cities wide YMCA members through routine communication channels including monthly general 
news emails; ‘healthy aging focus’ e-mails to target age groups; the YMCA website and social media; 
announcements in ongoing YMCA classes; and posters distributed within the YMCA facilities. We will also 
recruit non-members from the general community via the YMCA’s usual marketing methods (e.g. postal 
mailings), and will work in collaboration with local clinics and other community partners, located in proximity to 
the participating YMCA sites to facilitate referrals. Additionally, we will use existing data from the UMN 
Clinical and Translational Science Institute (CTSI, NIH UL1TR000114) Clinical Data Repository (CDR) hosted 
by the Academic Health Center Information Exchange (AHC IE). This data originates from the Electronic Health 
Records of patients of Fairview Health Services and University of Minnesota Physicians and currently includes 
over 2.3 million patients who have consented to have their data used for research. Eligibility criteria in this study 
will be applied to the data repository. 
 
In addition, recruitment of Facility Level Subjects (YMCA staff) to participate in qualitative data collection will 
occur through system-wide and targeted e-mails, newsletters, routine organizational meetings and special 
presentations (in-person or remotely via tele-and videoconferencing). Recruitment of Organizational Level 
Subjects (YMCA Twin Cities leadership, including decision makers and board members) will occur via routine 
meetings and communications (in-person or remotely e.g., via tele-and videoconferencing), special presentations 
and targeted e-mails. 
 
Minority Recruitment Efforts:  
Based on data gathered in the R21 phase, we learned that greater attention needs to be paid to addressing the 
barriers that currently exist to minority participation in research, as well as mindfulness based interventions. 
Common barriers include distrust of research, (e.g., fears about study procedures, lack of knowledge regarding 
mindfulness and wellbeing interventions, etc.), little perceived benefit to community, and conflicting time 
demands. To address these barriers we have updated our recruitment plans. This includes working closely with 
YMCA leadership (Dr. Hedy Lemar Walls, Chief Social Responsibility Officer-YMCA of the Greater Twin 
Cities, Bruce Yang Director of Social Responsibility-YMCA of the Greater Twin Cities) to coordinate 

Page 29 V10 February 2021 
 
 
community listening sessions and additional study information meetings. 
 
Community listening sessions: we have dedicated investigator and staff to meet in-person or remotely (e.g., via 
tele-and videoconferencing) with community stakeholders to better understand community needs, align values, 
and share information about the study and potential benefits of community participation. Identification of the 
stakeholders and facilitation of the community listening sessions will be conducted in partnership with the 
YMCA leadership (e.g. Dr. Lemar Walls and Mr.Yang). Listening sessions began in the R21 phase, and will 
continue through the R33, as screening and interventions continue to be implemented at the participating YMCA 
sites (see approved SARP).  Information gained in the listening sessions have been and will be used to inform 
revisions to recruitment related study materials (e.g. flyers, newsletters, informational meeting materials, etc.). 
The timing of community listening sessions will continue to be coordinated in a manner that allows for necessary 
approvals prior to use (e.g. participant-facing R33 materials require IRB approvals, and any affected changes to 
the R33 protocol require NCCIH and IRB approvals).        
 
Study information meetings: we have dedicated investigator and staff to perform study information meetings 
(in person or remotely via tele- and videoconferencing) to enhance outreach and recruitment at YMCA sites that 
typically draw from minority communities. Study information meetings will be held 1-12 weeks prior to the 
beginning of screening from specific YMCA sites as well as with interested community partners (see approved 
SARP).  Study personnel will provide information about the study, research procedures and terminology, and 
offer an opportunity for potential participants and family members to ask questions. To better navigate the time 
constraints of potential participants, the informational meetings will be held at convenient times (e.g. in the 
evenings following work hours). IRB approved study materials and information provided in these meetings will 
be guided by recommendations from the community listening sessions (as described above).   
 
In addition, we will seek guidance from the University of Minnesota’s (UMN) Recruitment Center to ensure a 
diverse study population. The Recruitment Center assist researchers with attaining recruitment goals using UMN 
partnerships, technologies and resources. StudyFinder, for example, extracts data from UMN affiliated enrolling 
studies listed on ClinicalTrials.gov and provides potential participants a simple way to identify studies that need 
volunteers. ResearchMatch is an electronic volunteer recruitment registry that also provides information about 
UMN studies and allows persons interested in research participation to self- register. Strategies include 
advertising in minority-oriented community newspapers (e.g., Latino American Today, Hmong Times) and 
hanging posters and flyers in University of Minnesota and other community clinics serving large minority 
populations. 
 
The YMCA also has numerous partnerships with organizations in the Twin Cities who represent women and 
minorities and are in close proximity to participating YMCA sites. This includes the Native American 
Community Clinic; Smileys Family Medicine Clinics (serving a large Somali population), and Westside 
Community Clinic (also known as La Clinica serving a predominantly Hispanic population). Further, the 
YMCA’s Diversity, Inclusion, and Global (DIG) Council which is charged with the responsibility for creating a 
welcoming and accessible environment to participants of all ages, genders, cultures, abilities and backgrounds, 
will serve as a resource for reaching out to minorities for the project. 
 
Compensation: All program fees are paid for by the study. Participants will be compensated for time associated 
with participating in this study sessions after they are enrolled. The maximum compensation for completing all 
study sessions is 210.00. Details of compensation procedures are included in the manual of operations and are  
addressed in the informed consent form. 

Page 30 V10 February 2021 
 
 
4.3.3 Documentation Procedures 
A comprehensive list of all subjects screened, how they heard about the study, whether or not they were 
enrolled, and the reasons for ineligibility or non-participation (if applicable) will be maintained electronically. 
 
4.3.4 Consent Procedures 
Consent will be sought from all participants by the PI, or designees (e.g. trained study staff). All individuals 
seeking consent from potential study candidates are required to complete the University of Minnesota’s Human 
Subjects and HIPAA related training. Documentation of consent at the following levels will be recorded by 
study staff in REDCap. In addition a paper or electronic copy of the signed and dated consent form will be 
secured for participant level participants. 
 
Participants will be re-consented (including documentation of written consent) if they elect to participate in a different 
wave other than when the original consent was obtained.  
Initial screen (online or by phone). Participants will provide verbal or electronic consent during the initial screen 
which will be documented in REDCap. Information provided by the participants will be used to assess whether or 
not they are eligible for a screening appointment (BL1). Prior to baseline screening, consent materials and other 
study related information will be sent to the study participant by post or e-mail.  
 
Baseline screening. Two screening evaluations will take place remotely via UMN supported, HIPAA secure 
videoconference (i.e., Zoom) and/or phone and will include the following consent procedures. 
• First baseline visit (BL1). Participants will review consent materials on their own prior to this visit.  
They will receive information about the study purpose, expectations for participation, risks and 
benefits, the voluntary nature of participation, confidentiality of information provided, research related 
injury etc. This information will be reviewed with potential subjects in a group setting or one-on-one. 
 
• Participants will be asked a series of questions (based on the Modified Deaconess Questionnaire) to 
assess their understanding of the research (i.e. prior to and/or during the BL1 evaluation). Staff will 
review participant responses and invite participants to ask questions prior to signing the consent form at 
BL1. Participants will e-sign the consent form in REDCap directly. Participants who do not have the 
ability to e-sign the consent form in REDCap (e.g., they do not have an electronic device) will be 
mailed a paper consent form. They will be instructed to sign the paper consent form and mail it back in 
a postage paid envelope. Once consent is obtained, additional screening activities will occur. 
 
• Second baseline screening (BL2). Participants will meet with study staff who will answer questions, 
provide clarification and reaffirm consent verbally. Confirmation of verbal consent will be documented 
at BL2 in REDCap. 
 
Documentation: Signed paper consent forms are secured in a locked filing cabinet at the Integrative Health 
Wellbeing Research Program offices at the University of Minnesota. Electronic consent forms are captured & 
stored in REDCap. Those who consent electronically will not have a paper consent form.  
 
Revisions: Changes to the consent form may be initiated by staff, investigators, the DSMB or the IRB because 
of the need for clarification or changes to the protocols. Changes will be approved by the study PI and then 
submitted to the IRB for approval. 
 

Page 31 V10 February 2021 
 
 
Training in Consent Procedures. In addition to the required institutional training in human subjects protection, 
prior to initiation of participant enrollment (and annually thereafter), all study staff will be required to undergo 
project specific human subjects training relevant to their role and be certified by the PI (or Co-I designee). 
Training will include: review of the key elements of the consent form including potential benefits, risks and 
alternatives to study participation, voluntary nature of participation, confidentiality, and disclosure of new 
information using standardized scripts. These will be reviewed and applied in practice scenarios. As part of the 
certification process, research staff will be required to participate in mock scenarios created by the PI or 
designees which address key elements of consent, including e-consent. Additional details are described in the 
manual of operations. 
 
4.3.5 Randomization Procedures 
Eligible participants will be randomized using the web-based Randomizing Module in REDCap.
12 We 
will use two strata for age (50-69 and 70+) and separate strata for sites. This will include “online 
sites/groups” for participants enrolled during specific time-intervals corresponding to treatment 
cohorts/classes after the transition to remote intervention delivery). Block randomization will be used 
with random sized blocks, varying between 4 and 6, and a 1:1 allocation ratio, to ensure group balance. 
Randomization will occur at the second, screening appointment (BL2) following inclusion/exclusion 
criteria confirmation (see 6.2.1 and 6.2.2). 
 
5. STUDY INTERVENTIONS 
 
5.1 
Interventions, Administration, and Duration 
We have used intervention mapping9,57,58 to align evidence-based behavioral theories and strategies with project 
objectives and stakeholder needs (at the participant, facility and organizational levels). 
 
5.1.1 Administration and Duration 
All intervention sessions will take place remotely via HIPAA secure videoconference (i.e., Zoom).  
 
The experimental and control interventions will be 8, 90-minute, remote group sessions over 8 weeks to meet 
the needs of middle to older age participants. This format is consistent with other YMCA programs, and will 
facilitate long term sustainability.  
 
Both experimental and control interventions will include the following standard elements: 
 
• An up to 90 minute orientation session prior to the start of the intervention sessions (i.e. Week 0) to get 
oriented to the video-conference environment. This will include practicing using the video conferencing 
application and tips for setting up one’s space for an optimal experience. Trained study staff will also be 
available to assist participants in solving technical problems.   
• Narrated videos presenting course concepts presented by a content expert. Videos will be 
interspersed with group discussions led by a YMCA staff facilitator and intervention specific 
activities (see Section 5.1.2 and 5.1.3). 
• Standard informational materials (web-based and print workbook) aimed at increasing knowledge of 
national physical activity guidelines for older adults1 as well as recommendations for activities to be 
done at home, in the community and through the YMCA. This will include short bouts of exercise 

Page 32 V10 February 2021 
 
 
frequently throughout the day, as well as suggestions for a range of indoor and outdoor options 
including walking, jogging, dancing, aerobic exercise classes, and use of stationary aerobic machines 
appropriate for different fitness levels. Additional information will include participation tips to ensure 
optimal learning, comfort and safety (see section 7.3). 
• Weekly reminder emails prior to each session along with instructions on how to participate in the study 
remotely (e.g., Zoom instructions) 
 
5.1.2 Experimental Intervention: Mindful Movement 
The Mindful Movement program is adapted from the widely used Mindfulness Based Stress Reduction Program 
(MBSR)41, with which the project collaborators have considerable experience.59-63 The program will focus on 
enhancing individuals’  mindfulness capabilities and skills, specifically attention regulation, body awareness, 
emotional regulation, and shifts in self-perception,42 by providing opportunities for education, practice, and 
social support in mindfulness practices to facilitate physical activity (see Figure 1 for Theoretical Framework). 
The class format will include the following elements in addition to the standard elements described above: 
narrated videos of a trained mindfulness instructor presenting mindful movement related course concepts and 
guided meditations. Videos will be interspersed with facilitator led group discussions and mindful movement 
exercises. 
 
Participants will be introduced to specific content including mindfulness practices and meditation techniques 
such as directed breathing and mindful awareness of thoughts and sensations during sitting, walking, lying 
down and other postures,41,64 as well as other contemplative (e.g. mindful) physical movements. Evidence-
based behavioral strategies will be incorporated into the session content including goal setting, self-monitoring, 
social support, relapse management, follow up prompts, and feedback.10,34 Support resources include a 
workbook to help set and monitor achievable goals for daily mindfulness practices and physical activity that 
builds up to 300 minutes (in 10 minute bouts) per week. The narrated videos (presented in the class sessions), 
as well as customized mindful movement videos and mindfulness meditation recordings (ranging from 5-20 
minutes to accommodate individual participant abilities and preferences) will be provided on a webpage to 
facilitate practice. Further details regarding delivery of the Mindful Movement intervention are provided in the 
manual of operations. 
 
5.1.3 Control Intervention: Keys to Health & Wellbeing 
We have adapted an existing education program “Keys to Health & Wellbeing to Healthy Aging” to use as the 
comparison intervention, which will be delivered in a similar manner as the experimental group to control for 
time and attention. The Keys to Health & Wellbeing program is adapted from a community-based educational 
program19 used previously by members of our team as a comparison group for a mindfulness intervention.63 The 
program provides participants useful content focused on ways to improve overall health. We have changed the 
name of the program to reflect our community partner’s current messaging which de-emphasizes focus on age, 
and re-emphasizes wellbeing for all. Further, we have updated the program content to include recent scientific 
evidence and resources that include health related topics requested by older adults at the YMCA. 
 
The class format will include the following elements in addition to the standard elements described above: 
narrated videos by a content expert presenting health related-related information. Videos will be interspersed 
with YMCA staff facilitator led group discussions and workbook exercises focused on things participants can 
do themselves to improve their overall health and wellbeing. Participants will be introduced to general health 

Page 33 V10 February 2021 
 
 
content including information regarding self-care tips for common health conditions and maintaining their 
social and mental health. 
 
Support resources include a workbook to help set and monitor achievable goals for applying the general health 
practices suggested by the program. The narrated videos (presented in the class sessions), as well as 
informational links, will be provided on a webpage to facilitate application of the information presented. 
Further details regarding delivery of the Keys to Health & Wellbeing intervention are provided in the manual 
of operations. 
 
5.1.4 Intervention Training 
YMCA staff will serve as intervention facilitators for the group interventions sessions. Facilitators will not be 
required to be certified in mindfulness (e.g. MBSR) or to have significant content expertise in the concepts 
related to the interventions (e.g. mindfulness and overall health and wellbeing) as this is not a reasonable 
expectation for YMCA staff. YMCA staff facilitators are expected to be trained sufficiently to understand the 
content to facilitate intervention sessions and to provide participant support in remote environments (e.g. 
videoconferencing). This approach has multiple advantages. First, it will facilitate consistency and fidelity 
across study cohorts and prevent cross-contamination (see section 5.2.2 below). Secondly, by refraining from a 
program that requires extensive training and certification of facilitators (which is what is required for MBSR 
instructor certification), there is a greater likelihood that the intervention can be adopted and sustained in 
YMCA settings. 
 
The PI, her designees and experienced content experts, will train YMCA staff to facilitate the intervention 
sessions to ensure participant safety and methodological rigor, and enhance long- term feasibility and 
sustainability at the YMCA. Further details regarding intervention training are provided in the manual of 
operations. 
 
Training of YMCA staff facilitators will include: 
• Human subjects protection and HIPAA training as required by the University of Minnesota 
• Study specific human subjects protection training  
• Review of rationale for experimental and control interventions and the importance of maintaining equipoise 
(note: blinding of facilitators is not possible) 
• Facilitation of interventions including review of key concepts and practices, and practical application 
through mock scenarios  
 
5.2 
Handling of Study Interventions 
5.2.1 Accountability Records 
For each session, facilitators will complete the intervention administration form in REDCap. The form 
documents participant attendance, adverse events, and includes a checklist of the elements covered in sessions 
(see Section 6.2.4) and any reasons for facilitators deviating from protocol. This will be reviewed by study staff 
and presented in a summary format to the investigators for review on a routine basis. 
 
5.2.2 Intervention Fidelity 
Intervention fidelity will be assessed by the PI’s designees using fidelity instruments that address whether or not 

Page 34 V10 February 2021 
 
 
content elements of intervention sessions were addressed, facilitator enthusiasm and other factors that could 
affect outcomes. At least 15% of the sessions will be assessed for fidelity. We will use adapted fidelity 
instruments used in previous studies. Fidelity of intervention delivery will also be assessed by review of session 
checklists completed by the facilitators. Fidelity procedures and instruments are further described in the manual 
of operations. 
 
5.2.3 Intervention Logistics (Group Size, Cohort Management) 
We anticipate the minimum class size will be 8 persons and the maximum will be 16 (which approximates 
existing YMCA and other mindfulness programs). However, classes may proceed with less than 8, or more 
than 16 persons. The PI will make the final determination as to whether or not a smaller or larger class is 
appropriate.  
 
5.3 
Concomitant Interventions 
5.3.1 Allowed Interventions 
Participants are allowed and encouraged to take part in physical activity and other interventions as they 
normally would, that are necessary for managing their health. 
 
5.3.2 Prohibited Interventions 
Participants will be excluded from participating in the study if at the time of enrollment, they are participating 
or plan to participate over the 8-week intervention period in the following: formal educational programs similar 
in terms of content (e.g. mindfulness based, general health), format (e.g. group sessions, facilitator led), and 
length of delivery (1.5 hours per week x 4-8 weeks) to the experimental and control interventions offered in the 
study. 
 
5.4 
Adherence Assessment 
Adherence to the intervention regimen is defined as follows: 
• >70% of enrolled participants adhere to the interventions (defined as attending 6/8 sessions, as measured 
by the YMCA staff facilitator and entered on the intervention administration form).  
• >70% of enrolled participants report participation in assigned intervention-specific ‘home practices’ >3 
days per week (as measured on the post-intervention W9 self-report questionnaire) 
• >80% of enrolled participants satisfied with experimental and control interventions (as measured on 
the post-intervention W9 self-report questionnaire) 
 
6. STUDY PROCEDURES 
The Schedule of Evaluations is presented in Table 1. 

Page 35 V10 February 2021 
 
 
 
6.1 
Schedule of Evaluations 
 
 
TABLE 1. SCHEDULE OF EVALUATIONS for RCT Participants 
Initial 
Screen 
BL1 
 
BL2 
 
Intervention 
Sessions 1-8 
 
W9 Follow-
Up 
W26 & W52 
Follow Up 
Informed consent 
x 
x 
x 
SRQ Demographics 
x 
x 
SRQ Health characteristics 
x 
x 
Anthropometrics 
x 
 
 
Accelerometer 
x 
x 
x 
x 
SRQ Quality of life 
x 
x 
x 
SRQ Exercise self-efficacy 
x 
x 
x 
SRQ Exercise expectations 
x 
x 
x 
SRQ Mindfulness 
x 
x 
x 
SRQ Wellbeing 
x 
x 
x 
SRQ Bodily pain 
x 
x 
x 
SRQ Physical activity 
x 
x 
x 
SRQ Social connectedness & assurance 
x 
x 
x 
SRQ Intervention satisfaction 
x 
x 
SRQ Home practice and engagement 
x 
x 
SRQ Qualitative data 
x 
x 
x 
x 
x 
SRQ Interoceptive Awareness 
 
 
x 
x 
x 
SRQ COVID-19 Impact/Zoom 
x 
 
x 
x * 
x * 
SRQ Working Alliance Inventory 
 
 
 
x 
SRQ Telehealth Usability Questionnaire 
 
 
 
x 
Inclusion/Exclusion Criteria 
x 
x 
x 
Enrollment/Randomization 
x 
Intervention Administration Form 
x 
Intervention Fidelity Form 
x 
Adverse events (AE) 
 
 
x 
x 
x 
Study Completion Form 
 
 
 
 
x 
KEY: BL=baseline; W=week; SRQ=Self-report questionnaire; MVPA=moderate-vigorous physical activity; 
SA=sedentary activity. *Impacted participants will be queried.  
 

Page 36 V10 February 2021 
 
 
6.2 
Description of Evaluations 
Table 1 summarizes the screening and follow up evaluations (participant-level subjects).  
 
6.2.1 Screening Evaluation 
 
During the screening process and prior to additional study visits post enrollment (if applicable), 
participants will be given instructions on how to participate in the study remotely. These instructions 
will include instruction sheets and tutorial videos for how to use videoconferencing applications. These 
will be sent via email, mail and/or reviewed during screening evaluations. 
 
Initial Screen. Potential participants will be initially screened for eligibility using direct electronic data 
entry in REDCap administered to the participant through a web-based survey interface or a phone 
screen with trained study staff. Both processes will include an introduction to the study and participants 
will be required to provide verbal or electronic informed consent (see 4.3.4). Participants will be asked 
questions pertaining to inclusion/exclusion criteria: age, self-reported physical activity levels, 
pregnancy, medical restrictions to increasing physical activity, contraindications to mindfulness 
practices (serious mental health condition, suicidality, substance abuse, PTSD and seizure disorders), 
and terminal illness. To assess which participants will need devices/equipment to participate, we will ask 
about electronic technology, internet access and technology related capabilities and needs. Eligible 
individuals will be scheduled for a first baseline evaluation. They will be asked to let study staff know 
prior to their BL1 visit if there are changes to their health status that may affect their eligibility. The 
manual of operations describes circumstances and procedures for additional screening.  
 
BL1 (first baseline evaluation). The first baseline evaluation will take place up to 90 days after the 
initial screen described above. This evaluation will be conducted via Zoom and/or telephone.  
• Trained study staff will perform informed consent (see Consent Procedures) 
• The Folstein Mini-Mental Status Examination (MMSE) will be administered to participants if 
cognitive impairment is suspected (e.g., repeating questions, unable to respond to/follow basic 
instructions)  
• Inclusion/exclusion criteria will be confirmed using eligibility checklists directly entered in 
REDCap by study staff.  
• Self-report questionnaires will provide baseline assessment of demographic and health 
characteristics along with self-reported outcome questionnaires (SRQs, see Section 9.5).  
• Study staff will collect anthropometric measurements by participant self-report; waist size will 
also be captured to fit individuals with an accelerometer, which is required for the baseline 
objective outcome measurement of physical activity. 
• Participants eligible for BL2 will be mailed accelerometer with wear and return mailing 
instructions (a pre-paid postage return envelope will be provided). 
 
 
BL2 (second baseline evaluation). A second baseline evaluation will take place 7-28 business days 
after BL1. This evaluation will be conducted via video/teleconference. Study staff will  
• Confirm consent and eligibility criteria 
• Administer BL2 participant survey if not completed prior to BL2 
• Inclusion/exclusion criteria will be confirmed using eligibility checklists completed by study 

Page 37 V10 February 2021 
 
 
staff via direct electronic entry into REDCap.  
• Final eligibility determination will occur following inclusion/exclusion criteria confirmation 
(see sections 4.3.5 and 6.2.2). 
 
6.2.2 Enrollment, Baseline, and Randomization 
Enrollment. Enrollment is defined as occurring at the date of randomization at which point all of the 
screening criteria are met and the individual has agreed to participate. 
 
Baseline Assessments. The following baseline assessments will be performed prior to randomization 
and are summarized in Table 1. 
 
Self-report questionnaires (SRQs) will be used to collect the following baseline variables. These are 
distributed between BL1 and BL2 (see Table 1) to reduce burden on participants. 
o Baseline demographics. Participants will report ethnicity, race, employment status, marital 
status, education, YMCA membership status, household income, use of ambulatory devices 
(e.g. cane), experience with study interventions, YMCA membership status on the self-report 
questionnaire. 
o Anthropometrics. Height and weight collected via participant self-report  
o Baseline health characteristics including current health conditions and smoking history on the 
self-report questionnaire. 
o Baseline SRQ outcome measures of quality of life, exercise self-efficacy and expectations, 
mindfulness, wellbeing, bodily pain, physical activity, social connectedness and assurance, 
COVID-19 impact, interoceptive awareness, and intervention satisfaction (see Section 9.5 for 
description of these outcome measures).Accelerometers will be used to collect objective physical 
activity outcomes (see 9.5); accelerometers will be mailed to qualified participants following the first 
baseline appointment. Participants will mail the devices back in postage-provided envelopes.  
 
Randomization. Prior to study enrollment, the study’s statistician will assign a member of his staff to 
create the random allocation tables according to the allocation plan (see Section 9.2), which will be 
administered using the randomization module in REDCap. Randomization will occur at BL2 after 
completion of all screening and baseline evaluations, and inclusion and exclusion criteria are verified 
(see Sections 4.3.5, 6.2.1 and 6.2.2). As each participant becomes eligible, project staff responsible for 
enrolling participants will access REDCap to obtain the electronically generated random assignment for 
that participant. All study personnel will be blinded to upcoming assignments. Enrolled individuals will 
commence their allocated intervention up to 14 business days post randomization. 
 
6.2.3 Blinding 
Blinded Personnel: The PI, select co-investigators, and the study statistician will be blinded until the 
database is locked. The study’s statistician will assign a member of his staff to create the random 
allocation tables according to the allocation plan, which will be administered using the randomization 
module in REDCap.  
 
Unblinded Personnel: The Project Director and Coordinator, YMCA staff facilitators, and data 
manager will not be blinded to study interventions. The Project Director and Coordinator facilitate 

Page 38 V10 February 2021 
 
 
scheduling and tracking of participants to ensure timely participation in intervention and other study 
activities. The YMCA staff facilitators conduct the remote intervention sessions. Unblinded personnel 
will not participate in data preparation or analyses. 
 
Individuals authorized to break the blind: The PIs and their investigator designees are authorized to 
break the blind.   
 
Circumstances for breaking the blind: This will occur when it is in the participants’ safety- related 
interest. The primary example is a reportable adverse event. 
 
6.2.4 Intervention & Follow Up  
• Pre-Intervention Session 0 (Week 0): Introduction to Zoom environment 
o 
Documentation of attendance and elements covered in session (using the 
intervention administration form) in REDCap 
o 
Adverse events (using the adverse event form) in REDCap, if applicable 
 
• Intervention Sessions 1-8 (weeks 1-8) 
o 
Documentation of attendance and elements covered in session (using the 
intervention administration form) in REDCap 
o 
Adverse events (using the adverse event form) in REDCap, if applicable 
o 
*Note at Week 8 only: distribution of accelerometer (see Week 9 Follow-Up) 
 
• Week 9 Follow-Up (week 9) (-7 / + 15 business days) 
o 
Return of accelerometer for measurement of physical activity (see Section 9.5) 
o 
Completion of self-report questionnaire (see Section 9.5) 
o 
Adverse Events (using the adverse event form) in REDCap, if applicable 
 
• Weeks 26 Follow-Up (-7 business days, + 60 business days) 
o 
Return of accelerometer for measurement of physical activity (see Section 9.5) 
o 
Completion of self-report questionnaire (see Section 9.5) 
o 
Adverse Events (using the adverse event form) in REDCap, if applicable 
 
 
6.2.5 Final Evaluation  
• Week 52 Follow-Up Visit/Final Evaluation (week 52+/-  15 business days) 
o 
Return of accelerometer for measurement of physical activity (see Section 9.5) 
o 
Completion of self-report questionnaire (see Section 9.5) 
o 
Adverse Events (using the adverse event form) in REDCap, if applicable 

Page 39 V10 February 2021 
 
 
o 
Study completion form in REDCap 
 
 
6.2.6 Additional Evaluation Related to Hybrid Effectiveness/Implementation Design and 
RE-AIM and PRECIS Frameworks 
The incorporation of the hybrid effectiveness-implementation designs and RE-AIM framework,18,55 
necessitate additional data collection, which is described below. 
 
• As part of Aim 3, we will gather contextual information using qualitative methods (via open-
ended surveys, interviews and field notes) related to barriers and facilitators, intervention 
satisfaction (at participant and facility levels), protocol confidence (facility level), and 
intervention relevance, practicality, and affordability (organizational levels). These data will be 
used to inform interpretation of results regarding the Mindful Movement program’s 
effectiveness and creation of a web-based toolkit (including Manuals of Operations, staff 
training materials, participants’ informational materials, etc.) to facilitate dissemination of 
program to other sites. 
 
7. SAFETY ASSESSMENTS 
 
7.1 Expected adverse events by intervention 
The inclusion and exclusion criteria and adverse monitoring procedures, have been developed to 
minimize the risk of adverse events. 
 
Mindful Movement Program. The probability of risks occurring as a result of mindfulness based 
interventions is considered very low. There is a very small chance of the following adverse events 
occurring: 
• Aggravation of PTSD symptoms associated with mindfulness and meditation practices 
• Aggravation of mental health symptoms associated with mindfulness and meditation 
practices 
• Cardiac events associated with increasing physical activity 
• Minor physical discomfort associated with mindfulness and meditation practice 
positions and postures 
• Seizures associated with mindfulness and meditation practices 
• Short-lasting muscle and joint soreness associated with recommended physical activity 
• Social anxiety associated with participating in group sessions 
 
Keys to Health & Wellbeing Program. The probability of risks occurring as a result of general 
education programs is considered very low. There is a possibility of the following adverse events 
occurring: 
• Cardiac events associated with increasing physical activity 
• Short-lasting muscle and joint soreness associated with engagement in recommended 
physical activity 

Page 40 V10 February 2021 
 
 
• Social anxiety associated with participating in group sessions 
 
7.2  Specification of Safety Parameters 
Safety of participants will be addressed in the eligibility screening that identifies persons that have 
contraindications to the interventions and increasing physical activity. Once enrolled, participants will 
be queried regarding the occurrence of adverse events (active surveillance) and reminded to report 
them to study staff should they occur (passive surveillance). 
 
 
7.3 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
Our methods and timing for assessing recording and analyzing safety parameters are described below. 
Mindfulness based interventions are generally presumed to be associated with minimal adverse events. 
However, similar to other fields, systematic adverse event reporting has been inadequate and the 
presumption of safety is not well informed by rigorous scientific evidence.65 This is confirmed by recent 
systematic reviews of mindfulness based interventions noting a lack of studies in which systematic 
assessment of adverse events occurred.66,67 Most mindfulness based intervention related adverse events 
are associated with meditation. There have been case reports and observational studies of mental health 
related symptoms including anxiety, panic, traumatic memory re-experiencing, and others.65 
Given the lack of rigorous evidence regarding mindfulness based intervention related adverse events, 
and to ensure participant safety, we have designed our inclusion and exclusion criteria to protect 
individuals in which mindfulness based interventions are considered contraindicated (e.g. 
active PTSD, suicidality, severe mental health disorders; see Section 4.2). This is based on 
recommendations from The University of Massachusetts Center for Mindfulness64 and our project’s 
expert consultants. We will also train staff to be aware of signs of potential distress, and how to address 
(this is detailed in the manual of operations). Further, we will use active adverse event surveillance 
methods in addition to passive surveillance (see Section 7.4). 
 
In addition we will provide: 
 
• Explicit instructions at multiple points to participants regarding what they should do if they don’t 
feel comfortable sharing in the group. This includes reviewing with participants: 
o It is important to take care of themselves and monitor how much information, if any, they 
are comfortable sharing;  
o It is fine to leave the session environment as needed;  
o It is okay to opt out or pass on any session activities, including discussions. This can be 
done by sending a private message to the facilitators within session or saying “pass” if 
called upon.  
 
These instructions are provided throughout the program: 
o In writing, in the workbook, which participants review with facilitators at the first session, 
and then are encouraged to read and use each week. 
o Verbally, by session facilitators, at the beginning of each session (as detailed in the 
manual of operations). 
o Verbally, by session facilitators, prior to any group discussions within the sessions (as 
detailed in the manual of operations).  
 

Page 41 V10 February 2021 
 
 
In addition, participants are routinely encouraged to let the study team know if they have any 
concerns or hesitations about participating in the sessions. This includes: 
 
o Each week enrolled participants are sent a reminder email about their upcoming 
intervention session. The study team will include a note encouraging participants to 
contact the PI/study team (i.e., respond to the email or call the study number (included in 
the email)) if they have any concerns about the upcoming session. All participant emails 
are acknowledged by a member of the study team and responded to accordingly. If a 
participant indicates they feel uncomfortable participating in group discussions, the 
session facilitator will be informed and the participant will not be called upon.  
 
 
7.4 
Adverse Events and Serious Adverse Events 
Prior to initiation of research activities, all project personnel engaged in human subject research will be 
required to complete CITI Program training in HSR and every 3 years thereafter. In addition, all project 
personnel will receive training in the application of HSR principles as they directly apply to the project. 
These will be delivered via live sessions conducted by the PI, designated Co-Is, and Project Director. 
They will be conducted prior to commencing related activities, and at routine intervals through the life 
of the project (no less than annually). Content will focus on human subjects related study protocols and 
procedures. 
 
YMCA staff, will not be involved in assessing, evaluating and reporting, adverse events (AEs). Instead, 
participating subjects will be instructed to contact the PI and/or the Project Director (or designee) with 
information about their event. The PI and/or the Project Director (or designee), will contact the DSMB 
Safety Officer, who will adjudicate the event using a standardized form in REDCap. The PI and/or the 
Project Director (or designee) may assist with adjudication. Additionally, YMCA staff made aware of 
AEs will be trained to notify the PI and Project Director in a timely manner using standardized study 
forms. 
 
7.4.1 Definitions 
Adverse Event. An adverse event (AE) is any untoward medical occurrence in a subject during 
participation in the clinical study or with use of the experimental agent being studied. An adverse 
finding can include a sign, symptom, abnormal assessment (laboratory test value, vital signs, 
electrocardiogram finding, etc.), or any combination of these regardless of relationship to participation 
in the study. 
 
Unanticipated Problems. The Office for Human Research Protections (OHRP) considers 
unanticipated problems involving risks to subjects or others to include, in general, any incident, 
experience, or outcome that meets all of the following criteria: 
• Unexpected in terms of nature, severity, or frequency given (a) the research procedures that 
are described in the protocol-related documents, such as the IRB-approved research protocol 
and informed consent document; and (b) the characteristics of the subject population being 
studied; 
• Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 

Page 42 V10 February 2021 
 
 
• Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
Serious Adverse Events. A serious adverse event (SAE) is one that meets one or more of the 
following criteria: 
• Results in death 
• Is life-threatening (places the subject at immediate risk of death from the event as it 
occurred) 
• Results in inpatient hospitalization or prolongation of existing hospitalization 
• Results in a persistent or significant disability or incapacity 
• Results in a congenital anomaly or birth defect 
 
7.4.2 Time Period and Frequency 
Collection and Time Period. Unanticipated problems will be recorded in the data collection system 
throughout the study. The PI, or designee, will record all reportable events with start dates occurring any 
time after randomization until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. At each study visit or data collection time point, the investigator, or designee, will inquire 
about the occurrence of AE/SAEs since the last visit/questionnaire. Study related AE/SAEs will be 
followed to stabilization/resolution post end of study participation.  
 
7.4.3 Characteristics of an Adverse Event 
 
Relationship to Study Intervention. To assess relationship of an event to study intervention, the 
following guidelines are used: 
• Related (Possible, Probable, Definite) 
• The event is known to occur with the study intervention. 
• There is a temporal relationship between the intervention and event onset. 
• The event abates when the intervention is discontinued. 
• The event reappears upon a re-challenge with the intervention. 
• Not Related (Unlikely, Unrelated) 
• There is no temporal relationship between the intervention and event onset. 
• An alternate etiology has been established. 
 
Expectedness. The Safety Officer, will be responsible for determining whether an SAE is expected or 
unexpected. The PI and/or designee may assist with determination, as needed.  An adverse event will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the intervention in the consent form. 
 
Severity of Event. The following scale will be used to grade adverse events: 
• Mild: transient or minimal symptoms; no change in activity level; no therapy or only 
symptomatic therapy required. 

Page 43 V10 February 2021 
 
 
• Moderate: symptomatic; moderate change in activity level; minimal decrease in social 
activities; specific therapy required. 
• Severe: incapacitating = ≥ 24 hours of any of the following: loss of work, bed rest, 
decreased social activities. 
• Serious: results in death; life threatening; requires inpatient hospitalization; results in 
persistent or significant disability; congenital anomaly or birth defect. 
 
7.5 
Reporting Procedures 
7.5.1 Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for unanticipated problems require the creation and 
completion of an unanticipated problem report form. OHRP recommends that investigators include the 
following information when reporting an adverse event, or any other incident, experience, or outcome 
as an unanticipated problem to the IRB: 
• Appropriate identifying information for the research protocol, such as the title, 
investigator’s name, and the IRB project number; 
• A detailed description of the adverse event, incident, experience, or outcome; 
• An explanation of the basis for determining that the adverse event, incident, experience, or 
outcome represents an unanticipated problem; 
• A description of any changes to the protocol or other corrective actions that have been taken 
or are proposed in response to the unanticipated problem. 
 
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using the 
following timeline: 
• Unanticipated problems that are serious adverse events will be reported to the IRB, 
Independent Safety Monitor(s), and NCCIH within 7 days of the investigator becoming aware 
of the event. 
• Any other unanticipated problem will be reported to the IRB, Independent Safety 
Monitor(s), and NCCIH within 14 days of the investigator becoming aware of the problem. 
• All unanticipated problems should be reported to appropriate institutional officials (as 
required by an institution’s written reporting procedures), the supporting agency head (or 
designee), and OHRP within one month of the IRB’s receipt of the report of the problem 
from the investigator. 

Page 44 V10 February 2021 
 
 
7.5.2 Adverse Event Reporting of Non-IND Studies 
SAEs that are unanticipated, serious, and possibly related to the study intervention will be reported to 
the DSMB, IRB, and NCCIH in accordance with requirements. 
• Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer, and Independent Safety Monitor(s) within 3 days of the 
investigator becoming aware of the event. Other serious and unexpected AEs related to the 
intervention will be reported within 7 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported 
to the Independent Safety Monitor(s), IRB, and other oversight organizations in accordance 
with their requirements and will be reported to NCCIH on an annual basis. 
• All other AEs documented during the course of the trial will be reported to NCCIH on an 
annual basis by way of inclusion in the annual report and in the annual AE summary which 
will be provided to NCCIH and to the Independent Monitors. The Independent Safety 
Monitor(s) Report will state that all AEs have been reviewed. 
 
7.5.3 Reporting of Pregnancy 
It is unlikely, but possible, given the age range of study participants that pregnancy may occur. 
Participants will be queried prior to enrolling regarding pregnancy status, and assessed for the 
study’s inclusion and exclusion criteria. Medical restrictions (of any type) for increasing physical 
activity are exclusionary for all participants. 
 
 
7.6 
Safety Monitoring 
A Data Safety and Monitoring Board has been assigned to perform independent study 
monitoring. 

Page 45 V10 February 2021 
 
 
8. INTERVENTION DISCONTINUATION 
 
8.1 Investigator Initiated Discontinuation 
If a participant experiences a change in their health status so they no longer meet the inclusion and 
exclusion criteria, or if new information arises suggesting the research is unsafe for them to participate 
in the intervention, the PI will withdraw them from the research without their consent. It is noted that 
that this occurrence is unlikely, given the interventions in this study are considered to be low risk. 
Participants will continue to be followed up for outcomes with their permission. In the event that the 
participant’s change in health status is temporary and they are able and willing to resume participation 
in the intervention, the participant will be administered relevant questions from the screening 
evaluations; if the participant meets the inclusion criteria, they will be allowed to continue with the 
intervention. 
 
8.2 Participant Initiated Discontinuation 
Participants will be asked to submit in writing to the PI (e.g. signed and dated letter or email) if they 
want to withdraw from the study. For reporting purposes, research staff will inquire about reasons for 
their withdrawal. Participants will also be asked if they’re willing to complete self-report 
questionnaires, and participate in objective data collection (e.g., accelerometer) as a means of 
collecting primary and secondary outcomes. If they refuse, participants will not be contacted by the 
study team. A formal letter will be sent by the PI, or designee, indicating receipt of their request for 
withdrawal and additional provisions around data collection, if applicable. The letter will reiterate our 
appreciation for their participation to date and remind participants that their withdrawal will not affect 
their relationship with the university or the YMCA. Regulatory bodies will be provided summary 
information related to attrition (e.g., losses to follow-up, withdrawals etc.). Participants will not be 
named. 
 
9. STATISTICAL CONSIDERATIONS 
 
9.1 
General Design Issues 
The reliability and validity of primary and secondary outcome measures are described in Section 
9.5.2 below. 
 
9.1.1 Hypotheses 
 
Our primary hypothesis is that there will be a significant advantage (>56 minutes) in terms of the 
primary outcome measure, weekly minutes spent in >10 minute bouts of MVPA for Mindful 
Movement over the Keys to Health & Wellbeing. 
 
Our secondary hypotheses are: 
• There will be significant advantages of Mindful Movement over Keys to Health & Wellbeing 
in terms of the secondary objective outcome measures of time spent per week in ≥ 10 minute 
bouts of MVPA; time spent per week in MVPA and sedentary activity; and steps per day 
• There will be significant advantages of Mindful Movement over Keys to Health & Wellbeing 
in terms of the secondary self-reported outcomes: quality of life, exercise self-efficacy and 
expectations, mindfulness, wellbeing, bodily pain and physical activity 

Page 46 V10 February 2021 
 
 
• There will be no significant advantages of Mindful Movement over Keys to Health & 
Wellbeing in terms of the secondary self-reported outcomes of social connectedness and 
assurance, and intervention satisfaction. 
 
9.2 
Sample Size and Randomization 
9.2.1 Sample Size 
The sample size is calculated based on the primary outcome of change in minutes/week spent in ≥10-min 
bouts of MVPA between baseline and post-intervention (9 weeks). In the R21 pilot study, we observed a 
standard deviation of 57 min for ≥10-min bouts of MVPA at week 9. This is lower than what we 
originally anticipated from the existing literature (120 min) 73 37 which provided the best available estimate at 
the time the original proposal was written. These studies however are not ideal representations of the 
interventions and population for the proposed study. Recognizing the standard deviation estimate from the 
pilot study is based on a limited number of participants (n=29), we performed 5000 bootstrap 
replications of our pilot sample and used the upper end of the distribution as a conservative variability 
estimate. This yielded a standard deviation estimate of 85 minutes, which when used as an estimate at 
baseline and week 9 will allow for detection of a medium effect size (0.50) difference between groups, of 
approximately 40 minutes in 182 participants (assuming alpha = 0.05, power = 0.85, correlation (ρ) 
between baseline and week 9 measures of 0.54, 10% loss to follow up; STATA, StataCorp. 2015 Stata 
Statistical Software: Release 14. College Station, TX: StataCorp LP). Varying the strength of correlation 
between the baseline and week 9 measures changes the detectable differences between groups from 31 
(ρ = 0.7) to 47 minutes (ρ = 0.3). Data from the R21 pilot study (ρ = 0.54) was used to estimate the 
correlation between baseline and week 9 MVPA measures. 
 
9.2.2 Randomization/Treatment Assignment Procedures 
Eligible individuals will be randomized using the web-based Randomizing Module in REDCap by 
trained study staff masked to upcoming treatment assignments. Randomization will be stratified by site 
(including a “online sites/groups” for participants enrolled during specific time-intervals corresponding 
to treatment cohorts/classes after the transition to remote intervention delivery) and age (50-69 and 
70+). Block randomization will be used with random sized blocks, varying between 4 and 6, and a 1:1 
allocation ratio, to ensure group balance. The study’s statistician will assign a member of his staff to 
create the random allocation tables according to the allocation plan, which will be administered using 
the randomization module in REDCap. Investigators will be blinded to individual participants’ group 
assignment until after the analysis by the study statistician is complete. Breaking the blind will occur if, 
in the event of a serious adverse event, expected or unexpected, it is necessary to protect patient safety 
and/or determine the relatedness of the event to the intervention. In these instances, the Project Director 
(who must remain un- blinded to coordinate individuals’ participation) will provide the PI or designee 
the individual’s specific intervention assignment. The breaking of the blind will be documented by the 
Project Director, and will be reported to all monitoring bodies as required. 
 
9.3 Definition of Populations 
All analyses will be conducted using the intention to treat principle. That is, all participants will be 
analyzed in the group to which they were randomized regardless of outside care, adherence to 
protocols, or compliance with follow-up. 
 
9.4 Interim analyses and Stopping Rules 

P a g e 4 7  V 1 0  F e br u ary 2 0 2 1  
 
 
I nteri m a n al ysis:  N o  i nteri m a n al ysis  is pla n n e d  be c a use  of  t he v er y  l o w ris k of  seri o us st u d y- relat e d 
a d verse e ve nts.  T he  D S M B  reser ves t he ri g ht t o re q u est o utc o m es  data  a n d perf or m  a n al ysis  at a n y  ti me 
wit h  N C CI H  a p pr o val.  T he  st u d y statisticia n will  pr o vi de  t h e gr o u p assi g n m e nt  c o d e t o t he D S M B  u p o n  
re q uest of  data.  
 
St o p pi n g  r ules:  T here  are  n o  st o p pi n g r ules. T he  st u d y ca n be  st o p p e d b y  t he I R B a n d D S M B  i n 
acc or da n ce  wit h  fe d eral re g ulati o ns (e. g., i n t he e ve nt  of  u ne x pect e d  a d v erse e ve nts  or  f ail ur e t o f oll o w 
st u d y pr ot oc ols  a p pr o priatel y).  
 
9. 5  
O utc o mes  
 
F or  Ai ms  1 a n d 2 : O bjecti ve  o utc o m es  of  p h ysic al  a cti vit y  a n d ot h er  sec o n d ar y o utc o mes  will  be  use d  
t o assess  t he relati ve effecti ve ness  of  t h e i nt er ve nti o ns; t hese o utc o mes  are d escri be d  b el o w.  
 
Pri m ar y  p h ysic al  acti vit y  o utc o m e : 
 Mi n utes/ wee k  s pe nt i n 1 0 -mi n  b o uts  of  M V P A  bet wee n  t he 7 -da y  baseli ne  a n d t he 7 - da y  
e n d of  t h e i nter ve nti o n p eri o d  ( 9 wee ks).  
 
Sec o n d ar y  p h ysic al  acti vit y  o utc o mes : 
 Mi n utes/ wee k  s pe nt i n 1 0 -mi n  b o uts  M V P A  fr o m baseli ne  t o 2 6  a n d 5 2  wee ks;  
 Mi n utes/ wee k  s pe nt i n M V P A  a n d se d e ntar y acti vit y  ( S A) fr o m baseli ne  t o 9  we e ks  
 Ste p  c o u nts/ da y.  
 
T he  p h ysical  acti vit y o utc o mes  will  be  c oll ect e d  b y  p artici pa nts  weari n g  t he Acti gra p h  G T 3 X +  
acceler o meter ( hi p plac e me nt).  A  f ull descri pti o n  of  acceler o meter  data  c olle cti o n  is pr o vi de d  i n t he 
ma n ual  of o p erati o ns.  
 
Data  will  be  c ollecte d  f or se ve n c o nsec uti ve d a ys  at  baseli ne  a n d we e ks  9,  2 6  a n d 5 2. 7 4  T he  Acti gra p h  
ca pt ures  i nt e grat e d ac celer ati o n  i nf or mati o n as  a n acti vit y c o u nt ( e. g. c o u nts  per mi n ute  ( C P M)), a n d 
pr o vi des  a n o bjecti ve  esti mate of  vertical  b o dil y  m o v e me nt. 7 5 -7 7  Acceler o m eters  ar e rec o m me n de d b y  
a ut h ors  of  s yste matic r e vie ws t o i m pr o ve t h e ri g or of p h ysical  a cti vit y base d  researc h.7 8  T he y  off er  a 
m ore  vali d  m eas ure  of  p h ysic al  acti vit y t ha n self- r e p ort meas ures  w hic h  te n d t o pr o vi de  o ver -
esti mates. 7 9  Accel er o meters  are a p pr o priat e f or use  i n ol der  p o p ul ati o ns 8 0, 8 1  a n d are  a m et h o d  of  d ata  
c olle cti o n  f or w hic h  t he i n vesti gat ors ha ve  c o nsi d era ble  e x p erie n ce. 8 1 -8 3  
 
We will use t he f oll o wi n g t hres h ol ds t o c haracteri ze le vels of a cti vit y: M V P A ( vect or ma g nit u de 2, 7 5 2 
C P M) a n d S A ( vect or ma g nit u d e < 2 0 0 C P M). 1 0 8, 1 0 9, 1 1 0 I n a d diti o n, we will c o n d u ct se nsiti vit y a nal yses 
t o assess t he i m pa ct of usi n g ot h er t hres h ol ds for M V P A ( 1, 9 5 2 C P M,  3 M E Ts) 8 4, 8 5 a n d S A ( < 1 0 0 
C P M, < 1. 5 M E Ts). 7  
 
Sec o n d ar y  self-re p ort  me as ures  
•  Q ualit y  of  lif e will  be  meas ure d  usi n g  t he E ur o q ol  5 D  ( E Q 5 D), w hic h  has  s o u n d relia bilit y a n d 
vali dit y, 8 6, 8 7  a n d  has  be e n  use d  i n e xercise a n d p h ysi c al  acti vit y st u di es of  ol der a d ults. 3 7, 8 1  T he  
E Q 5 D  ca pt ures  fi ve di m e nsi o ns  of  healt h  ( m o bilit y, self-car e, us ual  acti vities, pai n/ disc o mf ort,  
a n d a n xiet y/ de pressi o n)  o ver  5  le vels ( n o pr o ble m,  sli g ht pr o ble m,  m o der ate pr o ble m,  se vere 

Page 48 V10 February 2021 
 
 
problem, unable to perform/extreme problem). The advantage of the EQ5D over other 
instruments is its brevity and ease of use. 
• Exercise self-efficacy will be measured using the Self-Efficacy for Exercise (SEE) scale88 a 
reliable and valid measure of exercise self-efficacy tested in older adult populations. 
Individuals are asked to rate their confidence in their ability to exercise in each of nine 
situations. Confidence ratings range from 0 (not confident) to 10 (very confident).  
• Exercise expectations will be measured using the Outcome Expectations for Exercise-2 
(OEE-2), a 13-item instrument focused on beliefs about the positive and negative physical 
and mental health benefits of exercise.88 Responses range from 1 (strongly agree) to 5 
(strongly disagree). The OEE-2 has been shown to be reliable and valid in older 
individuals.88 
• Dispositional mindfulness will be measured with the Mindful Attention Awareness Scale 
(MAAS), which has demonstrated good internal consistency, reliability, construct validity, 
and responsiveness.89,90 The scale is comprised of 15 items measured on a 6-point scale 
(1=almost always, 6=almost never) which when combined represents a single construct of 
dispositional mindfulness. 
• State mindfulness will be measured using the Frieberg Mindfulness Inventory (FMI) to 
assess mindfulness skill.91,92 The FMI addresses 14 items with a four-point response scale 
(1=rarely, 4=almost always), and has been found to have good internal consistency and 
convergent validity.92 
• Wellbeing will be measured using the brief 8-item Flourishing Scale93 assessing perceived 
success in relationships, self-esteem, purpose, etc. It is psychometrically sound and provides a 
single psychological wellbeing score. 
• Bodily pain (including musculoskeletal pain) is a common occurrence with aging32,94 and may 
affect engagement in physical activity.95,96 Participants will be asked to rate their pain in the 
past 7 days in four bodily areas (legs including foot, ankle, knee and hip; arm including hand, 
wrist, elbow and shoulder; back including neck, mid and low back; and other) on an 11-box 
numerical rating scale (0=no pain, 10=the worst pain possible). 97 
• Physical activity (self-reported) will be measured using questions adapted from the 
International Physical Activity Questionnaire (IPAQ) which has been tested for reliability and 
validity, and used in older populations.98 The IPAQ is a nine- item instrument addressing 
days/week and minutes/day spent on physical activity in the past 7 days. While physical 
activity self-report measures tend to provide over-estimates,79 we will explore the extent to 
which this is true for the population. Self-report methods are less burdensome and costly, and 
would be better suited for routine evaluations in the long-term. 
• Social connectedness and social assurance will be measured using two 8-item questionnaires, 
and a six item scale (strongly agree, strongly disagree).99 
• Interoceptive Awareness will be measured using the Multidimensional Assessment of 
Interoceptive Awareness survey instrument (V2). 111 To reduce participant burden, we will 
limit measurement to four subscales which focus on domains covered in our mindfulness 
intervention: noticing (which includes awareness of uncomfortable, comfortable, and neutral 
body sensations); attention regulation (including the ability to sustain and control attention to 
body sensations); emotional awareness (including awareness of the connection between body 
sensations and emotional states); and self-regulation (including ability to regulate distress by 
attention to body sensations). 

Page 49 V10 February 2021 
 
 
 
• Intervention satisfaction will be collected using a question that has participant’s rate their 
overall satisfaction ranging from completely satisfied to completely dissatisfied. 
• Adherence to home practice will be collected using a question that asks the average number 
of days per week that participants completed the recommended home practices. 
• Adverse events will be collected through both active and passive surveillance. For active 
surveillance, participants will be asked to report side effects by choosing from a list 
generated from previous studies including exercise and older adults81,100,101and known 
potential risks of mindfulness interventions.64 Participants will rate the bothersomeness of 
these adverse events on an 11-box scale (0=not at all bothersome, 10=extremely 
bothersome). For passive surveillance, participants will be instructed to contact the PI or 
Project Director (see Section 7). 
• COVID-19 Impact and Zoom: Covid-19 impact may be asked at baseline. Enrolled 
participants may be queried following the intervention phase and at long-term follow-up 
data collection points (e.g., W26 and W52, per the study protocol). Future enrolled 
participants/cohorts may not be impacted, and thus the following questions will not be 
relevant. The PI and study team, with the study funder (NCCIH), will determine which 
cohorts of participants are affected by the COVID-19 pandemic and which participants will 
participate in the intervention remotely via Zoom; these individuals will be asked to 
answer questions related to pandemic impact on physical activity (5-item Likert scale), 
satisfaction with Zoom (7-point Likert scale) and advantages/disadvantages of Zoom using 
open-ended questions.  
• Working Alliance Inventory (WAI): We will measure participants’ views of the working 
alliance with facilitators using an adaptation of the Working Alliance Inventory (WAI) 
Short Form C.113The WAI is composed of three subscales—bond, task, and goal—which 
are important aspects of the therapeutic alliance.  
• Telehealth Usability Questionnaire (TUQ): Participants’ views of the remote intervention 
delivery platform will be assessed using items adapted from the Telehealth Usability 
Questionnaire.112  To reduce burden, we will limit measurement to items related to the 
perceived usefulness, ease of use, learnability, interface quality, interaction quality, and 
reliability of the remote delivery platform.  
 
For Aim 3: we will collect participation flow data (e.g. enrollment, participation, session attendance, follow 
up rates, etc.) and qualitative data (using qualitative surveys and field notes) to gather the necessary 
contextual information related to barriers and facilitators, intervention satisfaction (at participant and 
facility levels), protocol confidence (facility level), and intervention relevance, practicality, and 
affordability (organizational levels). 
 
9.6 
Data Analyses 
Outcomes data will be analyzed by a statistician masked to study group assignment. 
For Aim 1 to determine the relative effectiveness of Mindful Movement versus Keys to Health & 
Wellbeing in a Randomized Controlled Trial (RCT, n=182) we will conduct the following analyses. 
 
For the primary physical activity outcome: time spent per week in ≥ 10 minute bouts of moderate 
vigorous physical activity (MVPA) at 9 weeks; 

Page 50 V10 February 2021 
 
 
• An intention-to- treat analysis will be used including all participants with at least one 
outcome measurement in the analysis. 
• A mixed-model regression will be used for the primary outcome measure. The primary 
analysis will evaluate change in weekly minutes spent in 10-min bouts of MVPA using 
mixed model longitudinal regression (PROC MIXED in SAS) version 9.3 (SAS Institute, 
Cary, North Carolina). The analysis, using the baseline value as outcome, will determine 
between-group differences in study outcomes post-intervention period (9 weeks, the primary 
outcome) and at the 26 and 52 week follow up points. Clinical and demographic variables 
showing group differences at baseline will be used as covariates in the analysis if they are at 
least moderately correlated with changes in outcomes.105A strength of the mixed model 
analysis approach is the flexibility when data is missing at random.106 
• Efforts will be made to minimize the amount of missing data, but if missing data is present, 
the pattern of missing data will be determined to select the most appropriate form of 
analysis. Imputation strategies will be considered as sensitivity analyses if data are missing 
not at random.107 
 
The analysis will account for the correlated nature of repeated outcomes inherent in the longitudinal trial 
design. The variance-covariance structure that best fits the data will be used; most likely this is an AR(1) 
structure. From this model an overall intervention effect will be estimated (pooled across time points), as 
well as intervention effects at each of the post-intervention follow-up time points.
105 As a result of the 
pandemic, the structure of the trial has changed.  Previously participants were screened at four locations 
(clinical sites), and randomized to either intervention or control, with the intervention carried out in 
group sessions within each location.  In the present configuration, participants are (as before) 
randomized to treatment or control, but the intervention is carried out in virtual groups in specified time 
intervals by intervention teams that are not physical location-specific. Outcome data will be analyzed by 
treatment group as before, but we will include a stratifying factor: an indicator variable for the virtual 
group in a specified time interval to which participants are assigned (i.e. group 1, 2, 3, 4….etc.).  The 
main analytic model will include a random effect to account for clustering due to the group intervention.  
 
• To facilitate interpretation of trial results, an analysis will be done of group differences 
(including 95% confidence intervals) in proportions of participants who experienced at least a 
25%, 50%, or 75% increase in minutes/week spent in 10-min bouts of MVPA at week 9. 
 
For Aim 2, to determine the relative effectiveness of the two interventions as measured by secondary 
physical activity and self-report measures we will employ the same data analytic methods described above.  
In addition, we will conduct secondary analyses in response to the COVID-19 pandemic. These analyses 
will evaluate overall and between-group changes in objective and self-reported physical activity, key study 
implementation measures (e.g., intervention adherence, loss to follow-up, adverse events), and other 
secondary self-reported outcome measures by enrollment cohort. We anticipate 4 or more time partition 
strata that can be used 'as is' or grouped and included as a fixed effect in analytic models (e.g., 1. prior to 
MN state COVID response measures, 2. MN state 'social distancing' recommendation, 3. MN state 'stay 
home order', 4. More severe lockdown restrictions or a lifting of restrictions). We will also look at trends 
over a continuous timeline. We acknowledge that the study is likely underpowered for formal statistical 
inference with these added secondary analyses. 
 

Page 51 V10 February 2021 
 
 
For Aim 3, to facilitate interpretation of RCT results and provide resources for translation and 
sustainability we will analyze contextual information gathered using qualitative methods to inform 
eventual broad scale intervention implementation. A sample of qualitative texts will be reviewed to 
gain a general understanding of the data and establish preliminary codes as well as a working 
codebook, based on the study’s underlying theoretical frameworks.102-104All qualitative text will then 
be analyzed independently using NVivo; periodic meetings will be held to revise the codebook as 
necessary. Representative patient quotations will be identified during the coding process; coded 
themes will be grouped into larger thematic categories. Themes will then be quantified by categorizing 
them as present or absent for each case, and presented as frequencies.104 
 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
 
10.1 
Data Collection Forms 
Case Report Forms (CRFs). CRFs will be built into REDCap. The following case report forms will 
be used: 
• Initial screen — study registration information and data regarding initial study eligibility will 
be directly entered on this form either through self-report by participant OR trained study staff 
performing screening by phone. 
• Screening self-report questionnaires (BL1 and BL2) — baseline self-report outcomes, 
health characteristics, demographics, and information on eligibility will be directly entered 
on these forms through self-report by participants 
• Follow up self-report questionnaires  (Weeks 9, 26, and 52) — will be directly entered by 
participants 
• Eligibility determination forms (BL1 and BL2) — the eligibility determination forms will 
include a mixture of data directly entered by trained study staff and data with source 
documentation (e.g. verification of a signed consent form). The BL2 eligibility determination 
form will include stratification variables for treatment allocation. 
• Anthropometrics (BL1) – direct entry of self-report anthropometric data (height, weight) 
into REDCap will be performed by trained study staff.  
• Accelerometer form (BL2, Weeks 9, 26 and 52)–  – trained study staff blinded to treatment 
assignment will record information regarding wear-time compliance and objective physical 
activity using scored and summarized data from Actilife as the source document. 
• Intervention administration form (Sessions 1-8)— direct entry of session attendance will 
be done by trained study staff. Direct entry of pre-intervention session (i.e., W0) 
attendance will also be captured.  
 
• Intervention fidelity form (Sessions 1-8)— direct entry of  in-session observation done by 
trained study staff. 
 
• Adverse event form (Post Enrollment: W0 - Week 52)  — direct entry of adverse event 
details will be performed by trained study staff 
• Study completion form (Week 52 or earlier if withdrawal) – The study completion form will 

Page 52 V10 February 2021 
 
 
include data directly entered by trained study staff (e.g. reason for terminating study 
participation, number of intervention visits completed). 
 
Source Documents. Data that will serve as source documents include: 
• 
De-identified physical activity data collected by accelerometer and which will be downloaded 
via ActiLife software for secure management, processing and preparation for analysis. Ongoing 
ActiLife software support will be provided through ActiGraph’s maintenance agreement 
subscription. Scored and summarized activity data will be electronically merged into the project 
REDCap database. 
• 
De-identified qualitative data will be securely stored in REDCap. Collected outside of 
REDCap surveys (e.g. field notes from interviews) will be stored electronically on a password-
protected computer located at the University of Minnesota in a locked office, maintained by the 
Project Director. The computer is supported and maintained by the UMN AHC-IS with 
regular, automatic backups. 
• All paper source documents (e.g. informed consent & HIPAA combined form, medical waivers 
if applicable, paper version of self-report questionnaires in limited circumstances) will be 
stored in a locked file cabinet, in a locked office at the University of Minnesota maintained by 
the Project Director. The Project Director will have oversight for all paper forms and will route 
the forms from participating YMCA sites to the UMN. The Data Manager will log the receipt 
of all paper forms. 
• Electronic source documents will be stored on a password protected computer at the 
University of Minnesota in a locked office, without public access. The computer is 
supported and maintained by the UMN Academic Health Center-Information system. 
Participant ID numbers will be used to protect participants’ confidentiality. 

Page 53 V10 February 2021 
 
 
 
10.2 
Data Management 
The Principal Investigator, Data Manager and Project Director are responsible for ensuring the accuracy, 
completeness and timeliness of study data. All source documents will be completed in a neat, legible manner 
to ensure accurate interpretation of data. Case report forms (CRFs), and source documentation will be 
reviewed regularly for accuracy. A description of data collection forms and schedule of evaluations are 
provided in sections 6.1 and 10.1. 
 
10.2.1 Data security and storage 
CRFs for this study will be entered into a REDCap database, which uses a MySQL database via a secure web 
interface with data checks used during data entry to ensure data quality. REDCap includes a complete suite of 
features to support HIPAA compliance, including a full audit trail, user-based privileges, and integration with 
the institutional LDAP server. The MySQL database and the web server will both be housed on secure servers 
operated by the University of Minnesota Academic Health Center’s Information Systems group (AHC-IS). 
The servers are in a physically secure location on campus and are backed up nightly, with the backups stored 
in accordance with the AHC-IS retention schedule of daily, weekly, and monthly tapes retained for 1 month, 3 
months, and 6 months, respectively. Weekly backup tapes are stored offsite. The AHC-IS servers provide a 
stable, secure, well-maintained, and high-capacity data storage environment, and both REDCap and MySQL 
are widely-used, powerful, reliable, well-supported systems. Access to the study's data in REDCap will be 
restricted to the members of the study team by username and password. Electronic communication with 
outside collaborators will involve only non-identifiable information and investigators will be blinded to group 
assignment until after the analysis by the study statistician is complete. 
Electronic source documents will be stored on a password protected computer at the University of Minnesota 
in a locked office, without public access. The computer is supported and maintained by the UMN Academic 
Health Center-Information system. Participant ID numbers will be used to protect participants’ 
confidentiality. All paper source documents (i.e., medical waivers) will be stored in a locked file cabinet, in a 
locked office at the University of Minnesota maintained by the Project Director and her designees. De-
identified physical activity data collected will be downloaded via ActiLife software for secure management, 
processing and preparation for analysis. Ongoing ActiLife software support will be provided through 
ActiGraph’s maintenance agreement subscription. Scored and summarized activity data will be merged with 
the project REDCap database.  
 
10.3 
Quality Assurance and Quality Control 
10.3.1 Quality Assurance 
The primary method of data collection for participant self-reported outcomes will be direct electronic entry 
through a survey interface with REDCap. Logic rules specifying the type and range of acceptable responses 
will be programmed into REDCap. Participants will receive an error message if they enter an invalid 
response. Physical activity measures (primary outcome measure) will be collected via accelerometry. Subject 
compliance with accelerometer data collection (e.g. wear time) will be assessed at the relevant data collection 
timepoints and procedures will be outlined in the study manual of operations to enhance compliance with 
accelerometer wear time. In addition, data regarding accelerometer wear time compliance and the validity of 
physical activity data will be collected and actively monitored.  
 
10.3.2 Quality Control 
The REDCap study database limits invalid character and out of range responses and tracks missing 

Page 54 V10 February 2021 
 
 
responses. The Data Manager (or designee not involved in data entry) will perform quality control checks for 
10% of new records on a monthly basis by reviewing source documents (i.e. physical activity measures). 
Quality control checks will include, but are not limited to, verification of study eligibility, completeness of 
data collection, physical activity measure quality, and adverse event documentation. Reports on quality 
control findings will be provided to the PI and study Steering Committee on no less than a monthly basis. 
Study operating procedures will be modified as necessary based on quality control findings. Results of 
ongoing quality assurance and quality control procedures will be summarized in Reports for the Data Safety 
and Monitoring Board. 
 
10.3.3 Training 
Training for study staff responsible for data collection will be conducted prior to study recruitment. 
Certification by the principal investigator (or designee) requires adherence to standard operating procedures 
for data collection outlined in the study protocol. 
 
10.3.4 Metrics 
Data on adherence to the study protocols will be collected by research staff and reviewed monthly by the PI 
and the Study Steering Committee. These include study events (e.g. baseline evaluation, enrollment, 
intervention, follow up, adverse event reporting) occurring within specified time frames.  
 
The PI and Steering Committee will monitor the specific adherence metrics detailed in Section 5.4. If 
adherence falls below the rates, the PI will call a special meeting with the Study Steering Committee, co- 
investigators and others as needed (e.g. consultants), to re-assess and refine standard operating procedures to 
remedy the problem. 
 
10.3.5 Protocol Deviations 
A protocol deviation occurs when, without significant consequences, the activities on this study diverge from 
the UMN IRB approved protocol. Examples include divergence(s), that 
• reduce the quality or completeness of the data,  
• make the Informed Consent Form inaccurate, or 
• impacts a subject's safety, rights, or welfare.  
 
Protocol deviations include, but are not limited to the following: 
• Failure for participants to complete 6/8 intervention sessions 
• Failure to keep IRB approval up to date 
• Outcome assessment and/or measurement not performed 
• Implementing protocol modifications without obtaining prospective IRB approval; 
• Conducting research during a lapse in IRB approval; 
• Enrolling more subjects than what’s approved in the protocol; 
• Performing research procedures outside the protocol specified window; 
• Failure on the part of any individual involved in research review or oversight to abide by applicable laws 
or regulations, or the University of Minnesota IRB policies. 
• Randomization of an ineligible participant; not-adhering to inclusion/exclusion criteria; 
• Failure to obtain Informed Consent or altering from the informed consent process as described in the 
IRB approved protocol; 
• Obtaining consent using an outdated consent form; 
• Performing non-exempt human subject research without obtaining prospective University IRB approval; 

Page 55 V10 February 2021 
 
 
• Failure to report an SAE 
• Wrong intervention administered to a participant 
 
Protocol deviations will be logged by research staff in REDCap in accordance with the plan described above.  
Details regarding the protocol deviation including whether it resulted in an adverse event or is reportable to the 
IRB will be included in the log. Reports on protocol deviations will be reviewed by the PI and study Steering 
Committee on a regular basis. The DSMB will be provided a summary of protocol deviations in regular DSMB 
reports.  
Study operating procedures will be modified as necessary based on review of protocol deviation summaries. 
 
10.3.6 Monitoring 
Internal monitoring - Automated queries will be used to assess for protocol deviations when possible (e.g. 
missing evaluations or evaluations performed outside of allowed timeframe, non- compliance with assigned 
interventions). Potential protocol deviations that cannot be identified through automatic reports will be 
monitored through quality control procedures outlined in section 10.3.2 
 
External monitoring - A Data Safety and Monitoring Board has been assigned to perform independent study 
monitoring. The UMN IRB and NCCIH will also review study progress. The PI and the Study Steering 
Committee provide monthly monitoring (see Table 2). 
 
Westat is responsible for conducting NCCIH site monitoring visits. Monitoring visits include review of 
regulatory/essential documents, 100% of informed consents for enrolled participants, select participant records 
(e.g., source documentation, case report forms, and/or database entries) including documents that contain PHI, 
and other relevant study materials. Due to COVID-19, Westat will conduct monitoring visits remotely in lieu 
of on-site monitoring visits. If it is safe to do so in the future, Westat may return to on-site (versus remote) 
monitoring.   
 
Research staff will provide a current list of enrolled participant ID numbers to the monitor upon request. For 
the remote visit, research records, with PHI, will be uploaded by study staff to the HIPAA secure UMN Box 
(e.g., signed informed consent forms, HIPAA forms (if separate from the consent form), medical waivers). 
The Westat monitor will be given access to study documents in the UMN Box system to review per the 
monitoring requirements. Additional regulatory/essential documents will be uploaded to Zoom for review 
(e.g., IRB approval letters (notices of continuing review), delegation logs, human subjects training 
certificates, conflict of interest forms).  
 
The Westat monitor will also view select records that contain PHI, in the project database, REDCap, to 
review remotely. UMN staff will make select records available for the Westat monitor to review via HIPAA 
compliant Zoom videoconference. The Zoom videoconference meeting will not be recorded. Westat will not 
be given access to the full REDCap database. To protect participant’s confidentiality, records will be 
reviewed in a private space. Only the Westat monitor and designated study staff member will be invited to the 
videoconference review. 
 
 
 
 
 
 

Page 56 V10 February 2021 
 
 
Table 2. Monitoring 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including compliance 
with protocol enrollment criteria) 
Monthly 
PI, Steering Committee 
Semi-annually 
DSMB 
Status of all enrolled subjects, as of 
date of reporting 
Monthly 
PI, Steering Committee 
Semi-annually 
DSMB 
Findings from ongoing quality 
assurance and quality control 
procedures 
Monthly 
PI, Steering Committee 
Semi-annually 
DSMB 
Adherence data regarding study visits and 
intervention 
Monthly 
PI, Steering Committee 
Semi-annually 
DSMB 
AEs and rates 
Monthly 
PI, Steering Committee 
Semi-annually 
DSMB 
Annually 
NCCIH, IRB 
SAEs (unexpected and related) 
Per occurrence 
PI, DSMB, IRB, NIH/NCCIH 
SAEs (expected or unrelated) 
Per occurrence 
PI, Steering Committee 
Annually 
DSMB, IRB, NIH/NCCIH 
Unanticipated Problems (UPIRTSO) 
Per occurrence 
PI, DSMB, IRB, NIH/NCCIH 
Definitions: PI=Principal Investigator; DSMB=Data Safety and Monitoring Board; AE=Adverse Events; SAE=Serious 
Adverse Events 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY 
 
11.1 
Institutional Review Board (IRB) Review 
This protocol and the informed consent document and any subsequent modifications is reviewed and 
approved by the IRB. 
 
11.2 
Informed Consent Forms 
A signed consent (e-consent or written) form will be obtained from each participant. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and benefits of participation. A 
copy will be given to each participant and this fact will be documented in the participant’s record (REDCap). 
See Section 6.  
 
11.3 
Participant Confidentiality 
Procedures are in place for maintaining the full confidentiality of all information collected. Participant 
confidentiality will be protected by securing all hard copy study files in locked filing cabinets. Electronic files 
containing personal identifiers will be stored on secure servers operated by the UMN AHC-IS. All study staff 
receive training on privacy standards for maintaining participant confidentiality. All published reports will be 
of summary nature and no individual subjects will be identified beyond the investigative staff involved in the 
project. 
 
11.4 
Study Discontinuation 
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, or other government agencies 

Page 57 V10 February 2021 
 
 
as part of their duties to ensure that research participants are protected. 
 
12. COMMITTEES 
The study has a Steering Committee which will communicate in person, by phone or electronically to monitor 
study activities. It consists of the PI, Data Manager, Project Director, YMCA Project Coordinator and other 
co- investigators and study staff as needed. The study also has an Advisory Committee of community 
members, consultants and practitioners who are consulted as needed. Details regarding membership and roles 
are provided in the manual of operations. 
 
13. PUBLICATION OF RESEARCH FINDINGS 
Polices for publication of research findings from this research will be governed by the policies and procedures 
developed by the Steering Committee.  

Page 58 V10 February 2021 
 
 
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