Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older Adults
Phase: NA
Conditions: Sedentary Lifestyle
Sponsor: Kaiser Permanente

 
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     KP WA Implementation Date: 07/23/2018 
Page 1 of 61 
 
Revised 14APR2022 
 
 
 
 
 
KAISER PERMANENTE PROTOCOL FORM  
& STATISTICAL ANALYSIS PLAN (P 44) 
 
Health Aging Resources to Thrive (HART) 
 
NCT03739762 
 
IRB Approval Date: April 14, 2022 
 

 
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Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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Revised 14APR2022 
Protocol Title 
Randomized Trial to Reduce Sitting Time and Improve Cardiometabolic Health in Obese Older 
Adults 
 
Principal Investigator  
Dori Rosenberg, PhD, MPH 
 
Version Date 
Approved April 14, 2022 
 
Form Author 
Julie Cooper 
 
1. Objectives 
Describe in plain language the purpose, specific aims, or objectives and indicate the primary 
goal(s) of the study (e.g. safety, tolerability, effectiveness, feasibility, pilot study, etc.).  State the 
hypotheses to be tested. State primary and any secondary study endpoints. 
Purpose:  
Healthy Aging Resources to Thrive (HART) intervention focuses on reducing sitting time by 
standing more and breaking up prolonged bouts of sitting throughout the day. Because older 
adults with obesity rarely engage in physical activity, helping them sit less throughout the day 
could be a meaningful, but untested, health-promoting behavior. We will target a group with high 
prevalence of cardiometabolic conditions in which we have the opportunity to see the largest 
improvement in biomarkers related to cardiometabolic risk.1-3 We will conduct an efficacy 
randomized controlled trial to determine whether a sitting reduction intervention, improves 
behavioral and health outcomes to a greater extent than an attention-control group. The primary 
end point is 6 months. but participants randomized to the i-STAND intervention will be re-
randomized at 6 months to either receive no further contact or a booster session intervention.  
Everyone will be followed until 12 months after baseline. 
2022 BUDGET CUT UPDATE: As of March 31, 2022, participants randomized to the i-
STAND intervention will no longer be re-randomized at 6 months.  We will no longer follow 
participants to the 12-month timepoint and will end all activities after the 6-month timepoint.  
 
 
The specific aims of the study are to: 
Aim 1: Determine the efficacy of i-STAND to improve primary and secondary outcomes at 6 
months.   
Our primary outcomes are change from baseline in mean daily sitting time and systolic and 
diastolic blood pressure. We will compare group means for our primary outcomes between 
participants randomized to i-STAND versus attention control (“Healthy Lifestyles”) at 6 months. 
Secondary outcomes include cardiometabolic biomarkers (HbA1c,), weight, height, and physical 
function. 
 

 
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Aim 2: Determine the maintenance of sitting and blood pressure reductions over 12 months.  
We will then assess differences in primary outcomes at 12 months in the two i-STAND groups: 
with and without the booster intervention.  
Hypothesis 2:  i-STAND participants randomized to receive booster sessions will have 
reduced sitting time and improved cardiometabolic risk factors at 12 months compared 
to i-STAND participants receiving no further intervention and compared to the Healthy 
Lifestyles/attention control participants.  
2022 BUDGET CUT UPDATE: As of March 31, 2022, we are cutting Aim 2 so as to 
conserve funds to focus on Aims 1 and 3.  
Aim 3:  Explore moderators (e.g., age, sex, baseline physical activity) and mediators of 
reductions in sitting time (e.g., psychosocial variables) and cardiometabolic risk factors (e.g., 
changes in sitting time and/or physical activity).  
Additional exploratory analyses: We will explore whether i-STAND improves standing time, 
breaks from sitting, physical activity (step counts as measured by activPAL), quality of life, 
physical function, and depressive symptoms. Further, per protocol, analyses amongst those that 
adhered to the intervention will also be conducted.  
 
 
2. Background 
a. Scientific Background 
Provide the scientific or scholarly background for, rationale for, and significance of the research 
based on the existing literature and how will it add to existing knowledge. A list of references or 
bibliography must be included as part of this document or uploaded separately. 
Currently, about 40% of American adults over 60 are obese, defined as BMI ≥30.4,5 . Increased physical 
activity, particularly at moderate-to-vigorous levels, promotes healthy weight and has a plethora of 
positive effects on cardiometabolic conditions.6,7 Yet, of all age groups, older adults are the least likely 
to meet physical activity guidelines (2.4% of adults aged 65 and older by objective measures).8 Even 
with public health efforts to promote leisure time activity, rates are unchanged over the past 10 
years.9,10 Obese adults are even less likely than overweight and normal weight adults to be physically 
active.11-13 Many older adults face considerable barriers to physical activity including pain, fear, 
incontinence, fatigue, depression, lack of confidence, cost, safety, weather, and lack of facilities and 
transportation.12,14 Many older adults cannot appreciably increase their level of physical activity and 
reducing sedentary behavior could be a more feasible alternative.  A meta-analysis of 41 primarily 
prospective studies of self-reported sedentary time and health outcomes (including in older adults) 
found that, after adjusting for physical activity, individuals with higher sedentary time had greater risk of 
type 2 diabetes, all-cause mortality, incident CVD, and CVD mortality, with hazard ratios from 1.14 
(incident CVD) to 1.91 (diabetes).15  Sitting-reduction interventions in free-living conditions generally 
focus on younger adults in workplace settings and reduce sitting by an average of 77 minutes/8-hour 
workday;55 several have successfully improved waist circumference,16 blood pressure,17 and blood lipid 
profiles.16,18  Our own pilot work demonstrates that reducing sitting time is feasible and acceptable in 
older adults with obesity.19,20 

 
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We now wish to determine, in the first large scale RCT in an older population, whether reductions in 
sitting are associated with health outcomes at 6 months and 1-year post-baseline.  
2022 BUDGET CUT UPDATE: As of March 31, 2022, we are no longer collecting measures at 1 
year.  
 
 
 
b. Preliminary Data 
Describe any relevant preliminary data.  
Our main preliminary study was a recently completed pilot RCT in obese adults over 
age 60 (PI: Rosenberg).  We found high levels of acceptability and excellent adherence.  
Sitting significantly reduced and standing significantly increased for those receiving the 
intervention. 
 
 
 
 
 
Table 1. Preliminary sitting reduction studies from the study team 
Study & design 
Intervention(s) 
Results 
KPWA IRB 
Info 
Kerr 21 
Randomized pilot over 
3 weeks (N = 30; aged 
50-70, Mean BMI = 27, 
50% working, 50% 
retired)
Group 1: Increase standing 
time using standing desks. 
Group 2: Increase breaks from 
sitting using prompting 
strategies. Both met in-person 
weekly with health educator. 
Group 1: -130 min/day in activPAL sitting 
time (p < .01) 
Group 2: +40 activPAL breaks from 
sitting/day (p < .01) 
High intervention satisfaction and 
adherence 
N/A 
Rosenberg 1 
One-arm pre-post pilot 
over 8 weeks (N = 25; 
mean age = 71, mean 
BMI = 34, 28% 
diabetes, 48% 
hypertension, baseline 
activPAL sitting = 9.2 
hours/day) 
Five phone calls from health 
coaches, activPAL feedback 
after baseline and at 4 weeks, 
goal-setting, problem-solving, 
motivational interviewing, 
relapse prevention, cues, self-
monitoring 
ActivPAL sitting -27 minutes/day, standing 
+20 mins/day; accelerometer MVPA +24 
mins/wk (p’s < .05) improved 
Improved gait speed, depressive 
symptoms (p’s < .05), & weight (p = .07) 
Among those with SBP > 120, SBP (-6.8 
mmHg, p = .06) & DBP (-3.0 mmHg, p < 
.05) reduced 
High phone call adherence and study 
satisfaction 
417643-14: 
Take Active 
Breaks from 
Sitting Pilot 
(TABS-P) 
Study 
Rosenberg pilot RCT 
Randomized controlled 
pilot over 3 months (N 
= 60, mean age =68, 
mean BMI = 36, 23% 
diabetes, 60% 
hypertension, mean 
baseline activPAL 
sitting = 10.2 
hours/day)
Built on findings from our prior 
study and included 2 in-person 
sessions, 4 phone calls, 
activPAL feedback at baseline 
and 6 weeks, activity band to 
cue reminders to take breaks 
from sitting, and home 
environment audits 
activPAL sitting (-54 for I-STAND vs. 
control, p < .05) and standing (+42 
minutes/day for I-STAND vs. control, p < 
.01) improved  
 
Adherence to sessions was 99%, high 
study satisfaction 
817486-20: 
iSTAND R21 
SBP = systolic blood pressure; DBP = diastolic blood pressure; MVPA = moderate-to-vigorous physical activity 
 

 
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Revised 14APR2022 
 
3. Study Design 
Describe the overall approach of the study (e.g. prospective, interventional, observational, 
retrospective, etc.).  If your study includes more than one group, arm, or subject population, 
describe that here (for example, a study of both subjects and their caregivers, or a study with 
both a prospective interventional arm and a retrospective chart review arm).  
 
We will use a rigorous two-stage RCT design, adapted and refined based on our pilot studies, to 
test our novel intervention to reduce sitting time in older adults. After baseline measurements, 
284 participants will be randomized to the intervention (i-STAND) or an attention control group 
(Health Lifestyles). After 6 months, i-STAND participants will be re-randomized to receive either 
booster sessions or no further intervention. Attention control participants will receive no further 
intervention. All participants will be followed for 12 months total with assessments at baseline, 3 
and 6, and 12 months. Our primary outcomes are reduction in sitting time at 6 months, 
objectively measured using the activPAL device, and blood pressure. Our design allows us to 
answer novel questions about the impact of sitting reduction on cardiometabolic risk markers as 
well as maintenance of sitting reduction. I-STAND is designed to be easily implemented within 
our healthcare system to support practical and scalable approaches to improving cardiovascular 
health for high-risk older adults. 
2022 BUDGET CUT UPDATE: As of March 31, 2022, we are removing Stage 2 from the 
flow diagram above. Neither the i-STAND cohort nor the control cohort will have a 12-
month assessment. Furthermore, the i-STAND cohort will end without re-randomization 
as previously planned and will not have a subset of participants engaged in booster 
coaching sessions.  
 
 
 
4. Study Population 
 
a. Number of Subjects 
State the number (or approximate number, if appropriate) of subjects you plan to include at the 
KP region to which this study is being submitted. If applicable, distinguish between the number 
of subjects who are expected to be enrolled/screened and the number of subjects needed to 
complete the research procedures (e.g. numbers of subjects excluding screen failures).  
 
As appropriate, consider different populations of subjects within the same study (e.g. 
subject/caregiver, parent/child, patient/physician). If this is a multicenter study, indicate the total 
number of subjects to be accrued across all sites.  
 
Population 
Number to be 
screened/invited
Number of subjects to be 
enrolled

 
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b. Inclusion and Exclusion Criteria 
 
Describe the criteria that define who will be included or excluded in your final study 
sample. 
 
Describe how individuals will be screened for eligibility. 
 
Describe the plan for disposition of data collected during recruitment/screening in the 
event of a screen failure or when a potential subject is contacted but declines 
participation (e.g. destroyed immediately, destroyed at end of study, retained for 
separate analysis or so that subjects are not contacted repeatedly about participation 
after they have declined, etc.). 
 
  
Table 2. Inclusion criteria – ORIGINAL (In-Person)  COHORT 
 
Source  
Key Information/Description of Variables 
 
Inclusion Criteria: 
KP VDW 
 
over age 60; BMI ≥30 and <50 kg/m2 
 
men and women of all races and ethnicities  
 
We will oversample from clinics with greater minority 
member representation: Capitol Hill, Downtown, Northgate, 
Rainier, Burien, Renton, Federal Way, Factoria, Bellevue 
KP VDW 
no diagnosis codes indicating dementia or serious mental illness (e.g., 
schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., 
cancer) or deafness/significant hearing loss in the past 2 years 
KP VDW 
not residing in long-term care or skilled nursing and not receiving 
hospice care 
 
Phone screening/eligibility variables, such as: 
Participant 
 
Self-reported sitting time of 6+ hours per day 
 
Able to walk one block, able to speak and read English, no self-
reported hearing or vision limitations, sedentary time, use of an 
assistive device, able to stand from a seated position without 
help from another person 
 
No cognitive impairment that is perceived by the RS during 
phone screening 
KPWA member men and 
women who are between 
60-89
2500-3000* 
284* 
Original (In-Person)  Cohort 
- 
100 
REMOTE Cohort 
 
184 
Total:  2500-3000
Total:   284

 
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 
Willingness to wear device (activPAL) 
 
Willingness to participate in in-person visits in Seattle   
 
Willing and able to fast for up to 12 hours prior to in-person visit 
 
Ability to participate for a full 12-month period (i.e.: not planning 
on moving out of the state and unable to return for 12-month 
visit) 
 
No previous participation in either ISTAND or TABS 
 
No current participation in SMARRT 
 
 
Exclusion Criteria  
Exclusion criteria (are intentionally minimal as our intervention is low risk) in order of screening: 
1. 
Evidence of cognitive impairment/dementia/serious mental illness/terminal cancer or other 
illness including related diagnosis (diagnosis codes – pulled from VDW screening by 
programmer) 
2. 
BMI less than 30 or greater than 50 (pulled from VDW screening by programmer) 
3. 
Unable to speak and read English (phone screen) 
4. 
Unable to walk 1 block (with or without assistive devices) (phone screen) 
5. 
Self-reported sitting time less than 6 hours per day (phone screen) 
6. 
A record of participation in prior ISTAND or TABS studies (phone screen) 
7. 
Cancer diagnosis within past 12 months 
8. 
Residing in long-term care, hospice care or skilled nursing facility within past 12 months 
9. 
Participants in the ACT study will be excluded from this study.  This is necessary to 
eliminate participant burden due to both studies having lengthy visits and both studies 
wearing similar devices.   
10. Unable to summarize the study purpose and the activities prescribed to the participant 
after reading through the consent form with the RS at the Baseline visit. 
  
 
 
Table 2. Inclusion criteria – REMOTE COHORT 
 
Source  
Key Information/Description of Variables 
 
Inclusion Criteria: 
KP VDW 
 
over age 60; BMI ≥30 and <50 kg/m2 
 
men and women of all races and ethnicities from anywhere in 
the KPWA region (state-wide) 
 
We will oversample people of color statewide 
KP VDW 
no diagnosis codes indicating dementia or serious mental illness (e.g., 
schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., 
cancer) or deafness/significant hearing loss in the past 2 years 
KP VDW 
not residing in long-term care or skilled nursing and not receiving 
hospice care 

 
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Revised 14APR2022 
 
 
Phone screening/eligibility variables, such as: 
Participant self-
report 
 
Self-reported sitting time of 6+ hours per day 
 
Able to walk one block, able to speak and read English, no self-
reported hearing or vision limitations, sedentary time, use of an 
assistive device, able to stand from a seated position without 
help from another person 
 
No cognitive impairment that is perceived by the RS during 
phone screening 
 
Willingness to wear device (activPAL) 
 
Willingness to receive and use BP monitor and scale 
 
Ability to participate for a full 12-month period (i.e.: not planning 
on moving out of the state and unable to return for 12-month 
visit) [NOTE FOR REVIEWER: This will remain the 12 month criteria given that 
baselines will be finished before this change is made] 
 
Not previously enrolled in ISTAND or TABS  
 
Not currently enrolled in ACT, STOP-FALLS or SMARRT 
studies 
 
 
Exclusion Criteria  
All the same exclusion criteria as the Original Cohort, along with no current participant in the 
ACT, STOP-FALLS or SMARRT studies as self-reported on the phone screen conducted by 
they survey research group. 
 
 
c. Vulnerable Populations 
Indicate whether you will include or exclude each of the following special populations.  This 
refers to subjects who are known members of these populations upon enrollment or at any time 
during the study. Justify the inclusion of any of these populations. Describe additional 
safeguards to protect the rights and welfare of these subjects.  
 
Children 
 
Pregnant Women 
 
Neonates of uncertain viability or nonviable neonates (up to 28 days post birth) 
 
Prisoners (NOTE: The KP IRB does not have the appropriate membership to review 
research involving prisoners. Consultation with KFRI will be required.) 
None 
 
 
d. Identification of Subjects 
Describe how you will identify subjects. If you plan to use private records (EHR, Dept. of 
Licensing) complete 5.e, 5.f., and 5.g below as relevant.   

 
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ORIGINAL (In-Person) COHORT:  
A KPWA programmer will use KPWA’s electronic medical records and other automated data 
files to identify eligible King County, Washington subjects from virtual warehouse data.  (A 
waiver of consent for this identification method is requested as part of this application.)  The 
programmer will put the variables pulled into a database for recruitment tracking. 
 
 
 
 
 
Source (specify) 
(i.e., from KPWA, from 
an approved or 
previous study, from 
another site) 
List of electronic data that will be used to identify 
potential subjects.  
Date Range 
(if relevant) 
KPWA VDW 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ACT study records 
 
KPWA members residing in King County  
 
Contact information including phone and 
address 
 
over age 60 up to age 89;  
 
BMI ≥30 and <50 kg/m2;  
 
not residing in long-term care or skilled nursing 
and not receiving hospice care; and,  
 
no diagnosis codes indicating dementia or 
serious mental illness (e.g., schizophrenia, 
bipolar disorder), or a terminal or serious 
illness (e.g., cancer) in the past 2 years or 
deafness/significant hearing loss. 
 
Systolic blood pressure > 130 two times in 
previous 12 months (to be used for stratifying 
at randomization)  
 
Continuously enrolled at KP for previous 12 
months 
 
No record of death 
 
Not on the No Contact list 
 
Primary care at Capitol Hill, Downtown, 
Northgate, Rainier, Burien, Renton, Federal 
Way, Factoria or Bellevue - Consumer 
numbers from the ACT study participants will 
be accessed in order to make sure these 
participants are not included in the HART 
study population 
Jan 2017-
present 

 
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REMOTE COHORT:  
A KPWA programmer will use KPWA’s electronic medical records and other automated data 
files to identify eligible KP Washington state subjects from virtual warehouse data.  (A waiver of 
consent for this identification method is requested as part of this application.)  The programmer 
will put the variables pulled into a database for recruitment tracking. 
 
 
 
e. Waiver of Informed Consent for Identification from EHR or Other Private Records 
Provide rationale and justification for the Waiver of Informed Consent for identification of 
subjects, including:  
 
Does the proposed research present no more than minimal risk to the study 
participants?  
 
How the waiver of informed consent will not adversely affect the rights and welfare of the 
participants. 
 
Why this research cannot practically be carried out without a waiver of informed consent. 
Source (specify) 
(i.e., from KPWA, from 
an approved or 
previous study, from 
another site) 
List of electronic data that will be used to identify 
potential subjects.  
Date Range 
(if relevant) 
KPWA VDW 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KPWA members statewide 
 
Contact information including phone and 
address 
 
over age 60 up to age 89;  
 
BMI ≥30 and <50 kg/m2;  
 
not residing in long-term care or skilled nursing 
and not receiving hospice care; and,  
 
no diagnosis codes indicating dementia or 
serious mental illness (e.g., schizophrenia, 
bipolar disorder), or a terminal or serious 
illness (e.g., cancer) in the past 2 years or 
deafness/significant hearing loss. 
 
Systolic blood pressure > 130 two times in 
previous 12 months (to be used for stratifying 
at randomization)  
 
Continuously enrolled at KP for previous 12 
months 
 
No record of death 
 
Not on the No Contact list 
 
Jan 2017-
present 

 
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 
Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
A waiver of consent is requested to identify potentially eligible subjects for recruitment.  This 
waiver of consent is required because we do not know who to contact until we access electronic 
health care data to identify potentially eligible persons. This waiver of consent is required 
because it would be impractical to contact up to 7000 KPWA patients to obtain their informed 
consent for us to pull information from their medical chart. This waiver of consent is also 
requested so we can access consumer numbers from ACT study participants in order to make 
sure they are not included in our study population.    
The primary risk is a breach of confidentiality.  Health care benefits and insurance will not be 
impacted by this screening. No notification will be placed in the patients’ EMRs. 
With this waiver, we will mail letters to older adult KPWA patients meeting our initial eligibility 
criteria, offering them an opt-in or opt-out. Those who do not opt-out will be contacted by phone 
during which time the survey research team member will ask them several screening/eligibility 
questions, schedule their in-person baseline measurement visit, and notify a research specialist 
to mail them an activPAL activity monitor to wear for one week prior to the baseline 
measurement visit.   
 
 
 
f. 
Waiver of HIPAA Privacy Rule Authorization for Identification from EHR 
If you will not obtain a signed HIPAA Privacy Rule Authorization or if you want to eliminate any 
required language from the authorization, provide the following rationale and justification.  
 
Why the research could not practicably be conducted without the waiver. 
 
Why access to and use of the PHI is necessary for the research. 
 
Why the use or disclosure of PHI for the research poses no more than minimal risk to 
the subjects' privacy (must have an adequate plan to protect the PHI from improper use 
or disclosure, a plan to destroy identifiers at the earliest opportunity consistent with the 
purpose of the research, and when applicable, written assurances from collaborators 
that PHI will not be reused or re-disclosed to any other entity). 
A waiver of HIPAA authorization is requested to identify potentially eligible subjects for 
recruitment.  This waiver of consent is required because we do not know who to contact until we 
access electronic health care data to identify potentially eligible persons. This waiver of consent 
is required because it would be impractical to contact up to 7000 KPWA patients to obtain their 
consent for us to pull information from their medical chart. This waiver of consent is also 
requested so we can access consumer numbers from ACT study participants in order to make 
sure they are not included in our study population. 
 
The primary risk is a breach of confidentiality.  The data we screen will never leave KPWA 
firewall and thus will be well protected.  
 
We will destroy identifiers no later than 6/1/2028. 

 
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g. RCW 70.02 Requirements to Access HIPAA Covered Data without Consent for 
Identification from EHR (WA State Law)  
If you will not obtain written HIPAA Authorization provide the following rationale and justification. 
Explain how the research: 
 
Is of sufficient importance to outweigh the intrusion into the privacy of the patient that 
would result from the disclosure; 
 
Is impracticable without the use or disclosure of the health care information in 
individually identifiable form; 
 
Contains reasonable safeguards to protect the information from redisclosure; 
 
Contains reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research project; and 
 
Contains procedures to remove or destroy at the earliest opportunity, consistent with the 
purposes of the project, information that would enable the patient to be identified, unless 
an institutional review board authorizes retention of identifying information for purposes 
of another research project. 
 
This waiver of consent is required because it would be impractical to screen the data from 7000 
KPWA patients to obtain their consent for us to pull information from their medical chart. This 
waiver of consent is also requested so we can access consumer numbers from ACT study 
participants in order to make sure they are not included in our study population. Furthermore, 
this work could not be done with aggregate data only because we need to recruit individuals to 
participate in an intervention, which requires individual-level data. 
 
All data necessary to complete this research will be created and stored in secure computer files 
to which only the project staff will have access. Only study staff who are involved in subject 
recruitment will have access to the files.  This includes the research specialists (who will interact 
with subjects), research survey team members (who will be the first line of contact for the 
potential subjects), programmer, project manager, and potentially Dr. Rosenberg. 
 
We will destroy identifiers consistent with KPWA consent procedures.  
 
 
 
h.  Decisionally Impaired Adults   
State whether decisionally impaired adults will be included and explain the extent of cognitive 
impairment (complete, fluctuating, progressive, or temporary).  Justify their inclusion, and 
explain any protections to mitigate risk (such as the involvement of a caregiver or authorized 
representative).  Describe consent/assent procedures. 
Not applicable. one of our inclusion criteria is no diagnosis codes indicating dementia or serious 
mental illness (e.g., schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., 
cancer) or deafness/significant hearing loss in the past 2 years. 
 
i. 
Other Populations Targeted for Recruitment 

 
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If you are targeting a population that may be vulnerable to coercion or undue influence based on 
the specific circumstances of the study, describe how you will ensure that participation is 
voluntary and minimize any added risk. (Common examples include employees, students, 
people of low socioeconomic status, etc.) 
Older adults are often considered a vulnerable population. Older adults are the focus of our 
study because we believe that by decreasing their sitting time, their overall mental and physical 
health will be improved. Encouraging people to stand and move more is a low-risk intervention. 
To protect these older adult participants, the Survey Research Program staff and the study’s 
research specialists will be trained to ensure they clearly describe the study and offer numerous 
opportunities for questions and clarifications. In addition, we will not recruit participants who 
have a diagnosis of serious mental health conditions or dementia.   
 
 
j. 
Setting 
Describe the sites or locations where your research team will conduct the research. 
 
If this is a multi-site study: 
 
Specify what procedures are being performed at this site or by this site’s personnel 
(consider recruitment, consent process, study procedures, data analysis, etc.). 
 
State how each site will satisfy its IRB review requirements.  Indicate if you are asking 
this site’s IRB to rely on another IRB or if another institution would like to rely on this 
site’s IRB and include this information in the eIRB Initial Project submission   
 
For research conducted outside this site describe: (Community, Reservations etc.) 
 
Site-specific regulations or customs affecting the research at that location. 
 
Local scientific and ethical review structure outside this site. 
 
ORIGINAL (In-Person) COHORT:  
There will be both phone calls conducted by Survey Research Team members as well as 
Research Specialists and a Research Interventionist (the health coach), and in-person visits at 
KPWHRI’s research clinic in downtown Seattle, conducted by a Research Specialist. At the 
baseline visit, the Research Interventionist (the health coach) will also be present. We will have 
a physician on-call.  
 
By mail and phone: 
Potential participants will be mailed a letter describing the study with a phone line to call if they 
do not wish to participate. Those who do not decline will be called by our Survey Research 
Program staff. The Survey staff will obtain oral consent to be screened for eligibility by phone, 
answer any questions about the study, screen for eligibility, and, if eligible, obtain oral consent 
to wear the activPAL prior to the Baseline visit. Those who consent to participate in this stage 
will be scheduled by the Survey team for their Baseline measurement session.  At 6 and 12 
months, participants will receive an activPAL device and questionnaire by mail, and will 
participate in a follow-up in-person measurement visit (see In Person section below). 
 
For participants in both the intervention i-STAND group (Group A) and the Healthy Lifestyles 
group (Group B), additional activPAL measurements will be collected (via mailed activPAL) at 3 

 
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(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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months; for those re-randomized to the i-STAND booster group, they will also receive an 
activPAL at 9 months via mail. Neither the 3 or 9 month activPAL wears will be followed by an 
in-person visit. Reminder letters for upcoming in-person visits will be sent one-week prior to visit 
by the Research Specialist. For each period that an i-STAND subject wears an activPAL device, 
they will also receive a copy of their feedback chart via mail or in-person (depending on 
timepoint). If requested by the participant, reminders may be sent by email. Email addresses will 
be collected on the Contact Sheet if this request is made. Also see Supplement B. 
 
In person:  
Written consent to participate in the study will be captured at the in-person Baseline visit. One or 
two in-person health coaching sessions (depending on cohort). At Baseline, 6, and 12-month in-
person visits, measurement data will be obtained. These measurement data include HbA1c via 
capillary fingerstick blood sample; weight, waist and wrist circumference; blood pressure, 
physical function, collecting the inclinometer (activPAL), and self-reported survey data. The 
Research Specialist will provide a beverage and a snack after collecting the finger-stick blood 
sample. Participants will arrive at the KPWHRI research clinic for the baseline measurement 
session after an overnight fast of 12 hours (if they are able to), and will meet with the research 
specialist.  Participants will be informed that they are free to withdraw from the study at any 
time. The consent materials will comply with HIPAA standards and will encourage participants to 
contact the principal investigator or project manager if they have additional questions.   
In addition, we will collect adherence data (tracking completion of the in-person session and 
phone calls) for both intervention groups as well as additional inclinometer (activPAL) data from 
the i-STAND intervention group. We will audio-record phone sessions to be used in monitoring 
treatment fidelity.  
 
COVID-19 Update: 
While our in-person visits are restricted due to COVID-19 precautions, we will move to modified 
6 and 12-month remote visits so as to continue to collect as much data within the allotted time 
window for measurement time points. Measurement data collection will be altered to only 
include weight (self-reported), waist circumference (participants will be mailed a tape measure), 
blood pressure (participants will be mailed a BP monitor from an outside vendor pending their 
oral consent), activPAL (participants will continue to be mailed activPALs) and the self-reported 
survey data. Details included in the Procedures section of this application. We have updated 
Supplement B so as to enable us to send a link to the REDCap survey via email to participants 
for whom we have email addresses and who have given us permission to use this as a method 
of communication.  
 
REMOTE COHORT: 
Any participant recruited for remote baseline will be followed remotely for the entirety of the 
study period.  
 
There will be both phone calls conducted by Survey Research Team members as well as 
Research Specialists and a Research Interventionist (the health coach). There is a physician 
on-call available to support the team by phone and email if needed.  
 
 

 
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(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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By mail and phone: 
Potential participants will be mailed a letter describing the study with a phone line to call if they 
do not wish to participate. Those who do not decline will be called by our Survey Research 
Program staff. The Survey staff will obtain oral consent to be screened for eligibility by phone, 
answer any questions about the study, screen for eligibility, and, if eligible, obtain oral consent 
to wear the activPAL prior to the Baseline visit, as well as oral consent to give their 
name/address to a third party vendor in order for the study to send devices to the participant 
(such as a blood pressure monitor). Survey Research staff will also collect email addresses for 
those who agree to allow us to use email for consent, scheduling and sending program 
materials. Those who consent to participate in this stage will be scheduled by the Research 
Specialist team for their Baseline measurement PHONE session.  At 3, 6 and 12 months, 
participants will receive an activPAL device and questionnaire by mail or e-mail, and will 
participate in a follow-up measurement visit by PHONE. 
 
For Remote-Cohort participants in both the intervention i-STAND group (Group A) and the 
Healthy Lifestyles group (Group B), the same measurements collected at Baseline , 6 and 12-
month visits will also be collected (via mailed activPAL and phone measurement visit) at 3 
months.  Reminder calls for upcoming phone visits will take place one-week prior to the phone 
visit by the Research Specialist. For each period that an i-STAND subject wears an activPAL 
device, they will also receive a copy of their feedback chart via mail or email. If requested by the 
participant, reminder emails may also be sent by email.  
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the 
control cohort will have a 12-month assessment.  
 
Also by phone:  
The RS will obtain written or online consent to participate in the study during a pre-baseline 
phone call with the participant where they will review and answer questions posed by the 
participant. If the participant would like to participate after reading through the consent and 
reviewing over the phone with the RS, the participant will sign the consent form and then return 
it by mail. The RS will answer any questions about the consent form at this time. If the 
participant is willing to consent online, after discussing the consent process and reviewing the 
consent materials, the RS will email a link to a REDCap form with an online consent for the 
participant to electronically sign. Health coaching sessions by phone will take place starting 
within 2 weeks of the baseline measurement phone visit. During this baseline phone call, the RS 
will also collect height and weight to ensure we send them the right size cuff along with their 
blood pressure monitor to ensure accuracy.  
 
At Baseline, 3 and 6, and 12-month phone visits, measurement data will be obtained. These 
measurement data include self-reported weight (we will be mailing a scale), waist and wrist 
circumference; blood pressure (we will be mailing a BP monitor), physical function, collecting 
the inclinometer (activPAL), and self-reported survey data. We will notify participants via 
reminder call/email/letter that they should not consume caffeine or tobacco, or exercise, within 
30 minutes of their scheduled measurement visit, so as to ensure blood pressure readings are 
accurate, and we will advise participants that visits will need to be rescheduled if they have had 
any stimulants prior to the visit. When we schedule their first, baseline visit, we will advise them 

 
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Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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off this practice.  
We will also ask if they are scheduled to have the COVID-19 vaccine during these scheduled 
timepoints, as documented side effects from the vaccine such as fatigue or soreness may 
impact their ability to complete the measurement timepoint. Participants can choose NOT to 
share this information with us. If they do, we will document the date of the vaccine shot(s) in the 
database. The consent materials will comply with HIPAA standards and will encourage 
participants to contact the principal investigator or project manager if they have additional 
questions.  
In addition, we will collect adherence data (tracking completion of the in-person session and 
phone calls) for both intervention groups as well as additional inclinometer (activPAL) data from 
the i-STAND intervention group. We will audio-record phone sessions to be used in monitoring 
treatment fidelity.  
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the 
control cohort will have a 12-month assessment.  
 
 
k. Recruitment Methods 
Describe how study participants will be recruited and enrolled. Indicate whether you will openly 
recruit using advertisements, websites, or brochures. Indicate if you plan to do targeted 
recruitment using existing records or referral. (Upload all recruitment materials to your 
submission to the IRB.) 
 
Describe, by position/title, who will be recruiting and enrolling participants (providing the specific 
names of research team members is not necessary). 
 
Describe any plans for the participants in the currently proposed study to be re-contacted or 
recruited for future follow-up studies. (Note that participants should be informed of this potential 
for re-recruitment during the current study’s consent process.) 
Using successful, standardized procedures applied in numerous KP studies22-25 including our 
own pilot work,1 a member of the KPWA Survey Research Program will mail recruitment letters 
describing the study to current KP members who meet preliminary inclusion criteria based on 
age, BMI, and medical history from KPWA electronic data systems (see inclusion/exclusion 
section). An opt-out option will be included. Those that are interested can call a study phone line 
to express interest in learning about the study. In addition, the research specialist will 
proactively call potential participants who do not opt out of contact one- week after the mailing to 
describe the study in detail, verify eligibility with a screening questionnaire, obtain verbal 
consent from those who agree to participate, and schedule the baseline measurement visit 
(where written consent will be obtained). The Survey Research Program has an excellent track 
record of recruitment for RCTs.22,26-28 
ORIGINAL (In-Person) COHORT:  
Recruitment 

 
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(Use with Core Data Form) 
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NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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 
The study team programmer identifies a recruitment sample based on screening of the 
electronic medical record (we anticipate a recruitment rate of ~8% based on prior 
studies) who meet the study criteria.   
 
The survey research team mails letters describing the study in waves over 3 years.  The 
letter includes an opt-out option if potential participants do not wish to be contacted. 
Otherwise, within a week of sending the letter, a member of the survey research team 
will call the potential participant.  Participants are also given a study phone line where 
they can call us to express interest. 
 
When potential participants are reached by phone for study recruitment, the survey 
research team member describes the study, answers any questions, and assesses 
interest and eligibility in participating.  If there is interest, the survey research team 
member obtains oral consent to ask screening/eligibility questions, and asks the 
questions. If the participant fits our criteria and is interested, the survey research team 
member will obtain their oral consent to wear the activPAL device (which measures 
sedentary time) for a week, confirms their participation and schedules an in-person 
measurement visit.  If the participant is not interested, the survey research team will ask 
if they are willing to provide us with a reason why. 
 
Research specialists will mail out activPAL device after learning from survey research 
team that a potential participant has expressed interest in the study and is scheduled for 
a baseline visit. Approximately 12 days prior to the baseline visit, the device will be 
mailed. If a participant will not be seen for some time (e.g.: their visit is scheduled two 
months after phone consent), the research specialist will send an interim letter roughly 2-
3 weeks after they phone consent, reminding them of their consent to participate in 
wearing the device, and let them know to expect a package from the study in the weeks 
preceding their visit.  
 
See attached script for phone screening and recruitment, including oral consent. 
 
Potential participant receives device by mail and follows instructions (see attached) on 
how to wear the device 
 
At baseline visit, research specialist will obtain written consent from participant, collect 
the activPAL device which they wear into their visit, and proceed with gathering baseline 
visit measurements. 
Any ineligibility or refusal to participate information collected will be used for the purpose of 
investigating lower-than-expected recruitment rates. Note: the only data we will keep and use on 
those who are ineligible or who refuse to participate are the survey eligibility questions. 
REMOTE (Phone) COHORT 
Using successful, standardized procedures applied in numerous KP studies22-25 including our 
own pilot work,1 a member of the KPWA Survey Research Program will mail recruitment letters 
describing the study to current KP members who meet preliminary inclusion criteria based on 
age, BMI, and medical history from KPWA electronic data systems (see inclusion/exclusion 
section). An opt-out option will be included. Those that are interested can call a study phone line 
to express interest in learning about the study. In addition, the research specialist will 
proactively call potential participants who do not opt out of contact one- week after the mailing to 
describe the study in detail, verify eligibility with a screening questionnaire, obtain verbal 
consent from those who agree to participate, and schedule the baseline measurement visit 

 
Protocol Template 
(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
Page 18 of 61 
 
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(where written consent will be obtained). The Survey Research Program has an excellent track 
record of recruitment for RCTs.22,26-28 
Recruitment 
 
The study team programmer identifies a recruitment sample based on screening of the 
electronic medical record (we anticipate a recruitment rate of ~8% based on prior 
studies) who meet the study criteria.   
 
The survey research team mails letters describing the study in waves over 3 years.  The 
letter includes an opt-out option if potential participants do not wish to be contacted. 
Otherwise, within a week of sending the letter, a member of the survey research team 
will call the potential participant.  Participants are also given a study phone line where 
they can call us to express interest. 
 
When potential participants are reached by phone for study recruitment, the survey 
research team member describes the study, answers any questions, and assesses 
interest and eligibility in participating.  If there is interest, the survey research team 
member obtains oral consent to ask screening/eligibility questions, and asks the 
questions. If the participant fits our criteria and is interested, the survey research team 
member will obtain their oral consent to wear the activPAL device (which measures 
sedentary time) for a week, their consent to have their name/address given to a third 
party vendor to receive devices from the study, confirms their participation and is 
advised to expect a phone call from a Research Specialist within several days to 
schedule their phone-based measurement visit.  If the participant is not interested, the 
survey research team will ask if they are willing to provide us with a reason why. 
 
The Survey Research Group will mail out the consent form along with a welcome letter.  
 
About a week after the consent form has been mailed to the participant, the study team 
research specialist will confirm that the participant has the consent form in front of them 
in order to review written consent over the phone, have them sign and mail the form 
back to KPWHRI. When the form is received, a copy will be made and mailed to the 
participant to keep for themselves. During this phone call, the RS will also collect height 
and weight to ensure we send them the right size cuff along with their blood pressure 
monitor to ensure accuracy.  
 
Research specialists will mail the activPAL device, and order a blood pressure monitor 
and scale to be mailed to the potential participant, after learning from survey research 
team that a potential participant has expressed interest in the study. Approximately 25-
30 days prior to the baseline phone visit, the activPAL device will be mailed and the BP 
monitor and scale ordered. If a participant will not be seen for some time (e.g.: their visit 
is scheduled two months after phone consent), the research specialist will send an 
interim letter roughly 2-3 weeks after their phone consent, reminding them of their 
consent to participate in wearing the device, and let them know to expect a package 
from the study in the weeks preceding their visit. At this time the RS will also inquire 
about any scheduled COVID-19 vaccination that may overlap with the forthcoming 
measurement visit timetable, and remind them to avoid stimulants.  
 
See attached script for phone screening and recruitment, including oral consent. 
 
Potential participant receives device by mail and follows instructions (see attached) on 
how to wear the device and instructions to mail the device back to the Research 
Specialist 

 
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(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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 
At the baseline phone visit, measurements will be collected over the phone using the 
scale and blood pressure monitor sent in advance, with instructions (including avoiding 
stimulants), and with guidance over the phone. As well as other measurements including 
height (self-report), waist measurement (self-report using a tape measure that 
accompanies the scale) and a chair-sit exercise (modified physical function 
measurement as we are unable to do additional measurements of this nature that would 
happen in person).  
 
Any ineligibility or refusal to participate information collected will be used for the purpose of 
investigating lower-than-expected recruitment rates. Note: the only data we will keep and use on 
those who are ineligible or who refuse to participate are the survey eligibility questions. 
 
RESCREENING  
NOTE: As of the clinic/KPWHRI shutdown due to COVID-19, we had recruited 16 people for 
whom we had scheduled baseline visits in late March and April. These visits were postponed 
until we could determine how we would proceed with Baseline visits and consenting 
participants. Because of the changes between the Original Cohort and the Remote Cohort, 
those 16 individuals who have been waiting to be rescheduled will be contacted using a 
Rescreening Script (see attached) and screened again using the new, Remote Cohort 
recruitment screen to ensure they are still (a) interested and (b) eligible to participate now that 
they will be participating exclusively by phone. 
 
 
 
l. 
Informed Consent Process 
Describe how you will obtain and document consent, including: 
 
Where, when and how the consent process will take place. 
 
A process to ensure ongoing consent. 
 
Steps that will be taken to minimize the possibility of coercion or undue influence. 
 
Any steps that will be taken to ensure the subjects’ understanding. 
 
If you will conduct screening or any other research procedures before obtaining full 
informed consent, describe this. 
 
ORIGINAL (in-person) COHORT 
Potential participants identified via electronic health record screening, will be mailed a letter 
describing the study with a phone line to call if they do not wish to participate. Those who do not 
decline will be called by our Survey Research Program staff. The Survey staff will obtain oral 
consent to be screened for eligibility by phone, answer any questions about the study, screen 
for eligibility, and, if eligible, obtain oral consent to participate in the study and wear an activPAL 
device. Those who consent to participate will be scheduled for their baseline measurement 
session.   

 
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(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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At the first visit, the baseline visit, the research specialist will provide the subject with a written 
informed consent form (see attached) and describe the study to them, answer any questions, 
and obtain written consent. The RS will also ask the subject to summarize the study to the best 
of their ability. If they are unable to do so or cannot recall the primary parts of the study (ex: that 
they have to wear a device periodically; that they will have coaching calls; that they will be 
randomly assigned to one of two groups), they will be thanked for their time and excused from 
the study prior to randomization.  
 
As of Modification package 18, the consent form was revised to change the HIPAA authorization 
to extend the data collection period. An Addendum to Consent form will be used with those 
participants who have not started using the new consent form which includes added data and 
med capture information.  
COVID-19 UPDATE: For those participants who will have a remote 6 or 12 month visit and need 
to sign the first Addendum Consent mentioned above that was approved on 9/30/19, we will 
mail this form to be signed and mailed back.  
As of April 2020, we are proposing adding an interview at the 6-month timepoint (see page 23) 
and as such, are updating the original Consent form for anyone consented once we begin 
recruitment again, and another Addendum Consent to be mailed to participants (and mailed 
back).  
COVID-19 UPDATE: As of Modification Package 31, we are including an addendum oral 
consent to permit a continuation of coaching beyond the 6-month period. Due to COVID-19, we 
are unable to conduct study measurement visits on the schedules planned, and extending 
coaching contacts will serve to maintain contact with participants who are particularly vulnerable 
to isolation due to age and promote continued engagement in the study. 
 
The subject will be informed that at any time they can choose to withdraw consent.  
Consent will not be documented in their EMR.  
Note: in the consent form, we do not describe the standing desk, which is only offered to the i-
STAND cohort, because: 
1. This will be offered as a supplemental tool to support the standing intervention, which is 
the i-STAND intervention and will not be offered to the Healthy Living group 
2. We do not want those randomized to the Healthy Living group to feel as though they 
have been given a lesser program simply because they are not given these support 
devices (they are being given a different program, that doesn’t focus on standing).  
3. The desk is not part of the intervention and people are not being required to use it, 
(neither are they required to use the Fitness device) but mentioning it might create 
greater disappointment among people assigned to the control arm, leading to differential 
attrition and undermining our analytic power and scientific integrity of the study. The fact 
that we observed this in the pilot support this as a realistic scientific concern that needs 
to be managed appropriately. 
 

 
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(Use with Core Data Form) 
Form 
NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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COVID-19 UPDATE: As of Package 32, we are also offering an oral consent to participants to 
permit us to send them a blood pressure monitor via a third party vendor. Oral consent script is 
included in Package 32.  
 
REMOTE COHORT 
 
Potential participants identified via electronic health record screening, will be mailed a letter 
describing the study with a phone line to call if they do not wish to participate. Those who do not 
decline will be called by our Survey Research Program staff. The Survey staff will obtain oral 
consent to be screened for eligibility by phone, answer any questions about the study, screen 
for eligibility, and, if eligible, obtain oral consent to participate in the study, wear an activPAL 
device, and consent to receive devices (such as a blood pressure monitor) by mail from an 
outside third party vendor. After a positive screen, the survey staff will mail directly to the 
participant a copy of the consent form along with a welcome letter. 
Those who consent to participate will be scheduled by a study Research Specialist for their 
baseline measurement phone visit.  After scheduling the phone visit, the Research Specialist 
will order the scale (which comes with a tape measure) and the blood pressure device from a 
third party vendor. the baseline activPAL and instructions on how to use the device, as well as 
instructions on how to record weight and blood pressure when they receive their scale and 
blood pressure monitor. We are also including a bio sheet of all team members (previously, only 
coaches were on this sheet which was distributed by the coach at the baseline coaching 
session).  
During a phone call prior to the baseline phone visit, after the consent form packet has been 
mailed, the research specialist (after confirming that the participant has the consent form in front 
of them) will review over the phone with the subject the written informed consent form (see 
attached) and describe the study to them, answer any questions, and obtain either written 
consent (where in the form will be mailed back to KPWHRI and a copy will be made and sent 
back out to the participant ideally within 2 weeks of receipt) or online consent using REDCap, 
wherein the RS will email a link to the REDCap online consent form for the participant to 
electronically sign. The RS will also ask the subject to summarize the study to the best of their 
ability. If they are unable to do so or cannot recall the primary parts of the study (ex: that they 
have to wear a device periodically; that they will have coaching calls; that they will be randomly 
assigned to one of two groups), they will be thanked for their time and excused from the study 
prior to randomization.  
 
The subject will be informed that at any time they can choose to withdraw consent.  
Consent will not be documented in their EMR.  
Note: in the consent form, we do not describe the standing desk, which is only offered to the i-
STAND cohort, because: 
1. This will be offered as a supplemental tool to support the standing intervention, which is 
the i-STAND intervention and will not be offered to the Healthy Living group 

 
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(Use with Core Data Form) 
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NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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2. We do not want those randomized to the Healthy Living group to feel as though they 
have been given a lesser program simply because they are not given these support 
devices (they are being given a different program, that doesn’t focus on standing).  
3. The desk is not part of the intervention and people are not being required to use it, 
(neither are they required to use the Fitness device) but mentioning it might create 
greater disappointment among people assigned to the control arm, leading to differential 
attrition and undermining our analytic power and scientific integrity of the study. The fact 
that we observed this in the pilot support this as a realistic scientific concern that needs 
to be managed appropriately. 
 
 
m. Waiver of Informed Consent  
Provide rationale and justification for the Waiver of Informed Consent for this study, including:  
 
Does the proposed research present no more than minimal risk to the study 
participants?  
 
How the waiver of informed consent will not adversely affect the rights and welfare of the 
participants. 
 
Why this research cannot practically be carried out without a waiver of informed consent. 
 
Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation. 
We are only requesting a waiver of documentation of informed consent for initial screening of 
potential participants.  
 
n. Waiver of Documentation of Informed Consent  
Provide rationale and justification for the Waiver of Documentation of Informed Consent by 
identifying which of these two conditions applies and how.  
1) The research involves no more than minimal risk to participants AND involves no 
procedures for which written consent is normally required outside of the research 
context.    
2) The signed consent document would be the only record linking the participants to the 
research, and the principal risk to participants would be potential harm resulting from a 
breach of confidentiality. 
ORIGINAL (in-person) COHORT 
We are requesting a waiver of documentation of informed consent for initial screening of 
potential participants. Oral consent will be obtained by the survey research team prior to asking 
the screening/eligibility questions and mailing the activPAL.  Written consent will be obtained by 
the research specialist at the subsequent in-person baseline clinic visit.  
 
 
REMOTE (phone) COHORT 
We are requesting a waiver of documentation of informed consent for initial screening of 
potential participants. Oral consent will be obtained by the survey research team prior to asking 
the screening/eligibility questions and mailing the activPAL as well as getting consent to give 

 
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NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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address/name to a third party vendor for mailing of other devices.  Written or online consent will 
be obtained by the research specialist on a subsequent phone call prior to the baseline phone 
visit, and if in written form, the participant will mail back their consent form. 
 
 
o. Alteration of Informed Consent  
Identify the required elements of informed consent that you wish to remove or alter. Provide 
justification for their removal or alteration. 
We have created an Addendum to Consent form which will be presented to existing (previously 
consented) participants at follow-up visits (6 or 12-month depending on where in the timeline 
they are when this new Addendum is approved by IRB). This is only presented to participants 
who signed the original consent form which doesn’t include the new elements recently approved 
by the IRB on 9/10/19.  
 
ORIGINAL (in person) COHORT 
COVID-19 UPDATE: We have created an Addendum to Consent oral script to offer participants 
the option to continue coaching past the protocol timepoint as dictated in the original consent 
form until they are able to complete their remote 6 or 12 month assessments (for those 
receiving the booster intervention). The majority of participants will only have 10 coaching 
sessions and a subsection of i-STAND cohort will receive booster sessions. This is to ensure 
that participants are still working on their study goals up until their outcome measures can be 
assessed. For those who have already completed a 10th call, the coach will reach out by phone 
and ask if they are interested in optional additional coaching. If the participant is interested, the 
coach will use the oral consent process. For those who have not yet had this 10th session and 
have one forthcoming, the coach will ask at the end of that call if they are interested in optional 
additional coaching and use the oral consent process.  
 
COVID-19 UPDATE: We have created an Addendum to Consent oral script to offer participants 
the option of receiving a blood pressure monitor (to keep) which we will send by a third party 
vendor. The oral consent is to verify their permission to share their mailing address and name 
with a third party in order to mail the device. Participants can choose not to allow this, in which 
case we will not collect their blood pressure data in the remote measurement visit.  
 
REMOTE (phone) COHORT 
No addendum consents will be implemented at this time with any newly recruited participants 
into the Remote Cohort. The additional coaching option will not apply to this cohort and the 
consent to give their name/address to a third party is covered in the screening that occurs 
during recruitment by the survey research group. 
 
2022 BUDGET CUT UPDATE:  
As of March 31, 2022, and upon approval of this IRB submission (Package 58) we will be 
mailing an Informational Letter to participants in both cohorts advising them of the change to the 
study and providing them a phone number to call if they have concerns. These letters will be 
sent in lieu of a revised consent form. In the letter we will highlight: 
 

 
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NCRSP HRP FORM KP-202, Version 1.0 
     KP WA Implementation Date: 07/23/2018 
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 
Removing the 12-month visit which means $30 less than they originally thought they’d receive for 
participation 
 
There is no change to risk 
 
There will be no potential for additional coaching beyond 6-months (only offered to a subset of the 
participant population) 
 
 
 
p. Non-English-Speaking Subjects  
If subjects who do not speak English will be enrolled, describe how the consent discussion will 
take place and indicate if translated consent forms or short forms will be used. Confirm that an 
interpreter will assist with the initial consent process and subsequent study visits. 
Not applicable 
 
 
q. Assent of Children and Parent Permission 
IMPORTANT NOTE: Consent may be obtained in certain situations.  For example, conducting 
family planning or sexually transmitted disease (STD) research.  In addition, for older children 
ages 16 and up who participate in an adult study, the consent document can be used in place of 
the assent document.   
 
Describe how you will obtain and document assent/parental permission, including: 
 
Describe your plan for obtaining parent permission.  The permission of one parent is 
generally sufficient for minimal risk research, or for greater than minimal risk research if 
there is the potential for direct benefit to the child. 
 
Note that for studies involving greater than minimal risk with no prospect of direct benefit 
to the child, permission of both parents is required unless one parent is deceased, 
unknown, incompetent, or not reasonably available, or when only one parent has legal 
responsibility for the care and custody of the child. 
 
Describe whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  
 
Indicate whether assent will be obtained and documented from all, some, or none of the 
children. If assent will only be obtained from some children (because of very young age, 
severe cognitive impairment, etc.), indicate which children will be required to assent and 
which will not. 
 
When assent of children is obtained, describe whether and how it will be documented. 
 
When subjects might reach the age of majority during the study, describe the plan to 
obtain consent from these subjects at that time using an adult consent form. 
Not applicable  
 
r. Adults Unable to Consent/Decisionally Impaired  
Describe the consent/assent process for Adults Unable to Consent/Decisionally Impaired, 
including: 
 
Describe the process to determine whether an individual is capable of consent. 
 
List the individuals from whom permission will be obtained in order of priority. (E.g., 
durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child.   

 
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 
Describe the process for assent of the subjects. Address the following: 
o Whether assent will be required of all, some, or none of the subjects. If assent 
will be obtained from some subjects, indicate which subjects will be required to 
assent and which will not. 
o If assent will not be obtained from some or all subjects, an explanation of why 
not. 
o When assent is obtained, describe how it will be documented.  
 
Describe the plan to obtain consent if subjects might regain capacity to consent during 
the study. 
Not applicable: one of our inclusion criteria is no diagnosis codes indicating dementia or serious 
mental illness (e.g., schizophrenia, bipolar disorder), or a terminal or serious illness (e.g., 
cancer) in the past 2 years. 
 
 
s. HIPAA Privacy Rule Authorization – if study will use or disclose Protected Health Information 
(PHI) 
Describe the plan to obtain a signed Privacy Rule Authorization from each subject. 
HIPAA authorization will get signed with the consent form at the Baseline Visit. 
 
t. 
Waiver of HIPAA Privacy Rule Authorization  
If you will not obtain a signed HIPAA Privacy Rule Authorization, or include HIPAA authorization 
in the consent form, or if you want to eliminate any required language from the authorization, 
provide the following rationale and justification.  
 
Why the research could not practicably be conducted without the waiver. 
 
Why access to and use of the PHI is necessary for the research. 
 
Why the use or disclosure of PHI for the research poses no more than minimal risk to 
the subjects' privacy (must have an adequate plan to protect the PHI from improper use 
or disclosure, a plan to destroy identifiers at the earliest opportunity consistent with the 
purpose of the research, and when applicable, written assurances from collaborators 
that PHI will not be reused or re-disclosed to any other entity). 
Not applicable 
 
 
u. RCW 70.02-Requirments to Access HIPAA Covered Data without Consent  
If you will not obtain HIPAA Authorization or Consent provide the following rationale and 
justification. Explain how the research: 
 
 
Is of sufficient importance to outweigh the intrusion into the privacy of the patient that 
would result from the disclosure; 
 
Is impracticable without the use or disclosure of the health care information in 
individually identifiable form; 
 
Contains reasonable safeguards to protect the information from redisclosure; 
 
Contains reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research project; and 
 
Contains procedures to remove or destroy at the earliest opportunity, consistent with the 
purposes of the project, information that would enable the patient to be identified, unless 

 
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an institutional review board authorizes retention of identifying information for purposes 
of another research project. 
Not applicable 
 
 
5. Study Procedures 
Describe and explain the study design, including: 
 
Procedures to monitor subjects for safety, including who will review the data and at what 
frequency for safety issues. 
 
Procedures performed to lessen the probability or magnitude of risks. 
 
All drugs and devices used in the research and the purpose of their use, and their 
regulatory approval status. 
 
The source records that will be used to collect data about subjects. (Attach all surveys, 
scripts, and data collection forms.) 
 
What data will be collected including long-term follow-up. 
 
The duration of an individual subject’s participation in the study. 
 
The duration anticipated to enroll all study subjects. 
 
The estimated date for the investigators to complete this study (complete primary 
analyses) 
NOTE:  It should be clear exactly which procedures will be conducted for the research as 
opposed to procedures the subjects would undergo (in the exact manner described in the 
protocol) even if they were not participating in the study. 
 
Describe procedures that will be followed when subjects withdraw from the research, including 
withdrawal from intervention but continued data collection. 
 
Describe any anticipated circumstances under which subjects could be withdrawn from the 
research without their consent.   
 
Describe any procedures for orderly termination. 
 
If the study involves genetic testing or collection of genetic information, describe this. 
 
 
 
 
 
 
Data, sources, and date range   
The following table shows how outcomes data will be collected 
 
Source (specify) 
(i.e., from KPWA, 
or from an 
existing or 
previous study) 
Key Information/Description of Variables 
Date Range 

 
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activPAL activity 
monitor 
PRIMARY OUTCOME
 
Change in mean daily sitting at 6 months 
 
Baseline to 6-months 
ORIGINAL 
COHORT: 
In-person 
measurement visit 
at KPWHRI 
COVID-19 UPDATE 
AND NEW 
REMOTE 
COHORTREMOTE 
MEASUREMENT 
PRIMARY OUTCOME
 
Change in systolic and diastolic blood pressure  
Baseline to 6-months 
In-person 
measurements 
collected at clinic 
visit at KPWHRI 
COVID-19 UPDATE 
AND NEW 
REMOTE COHORT: 
REMOTE 
MEASUREMENT 
OF WEIGHT 
SECONDARY OUTCOMES
 
Change in HbA1c (Original Cohort only) 
 
Change in Weight 
 
Baseline to 6 months 
In-person 
measurements 
collected at clinic 
visit at KPWHRI 
COVID-19 UPDATE 
and REMOTE 
COHORT: REMOTE 
MEASUREMENT 
OF WEIGHT and 
BP 
OTHER EXPLORATORY OUTCOMES for i-STAND BOOSTER 
ONLY 
 
Change in HbA1c (original cohort only) 
 
Change in Weight 
 
Change in systolic and diastolic blood pressure 
 
Baseline to 12 
months 
activPAL activity 
monitor 
OTHER EXPLORATORY OUTCOMES for i-STAND BOOSTER 
ONLY 
 
Change in time spent sitting or lying down 
 
Change in step counts  
 
Baseline to 12 
months 
Participant 
questionnaire 
OTHER EXPLORATORY OUTCOMES
 
Change in quality of life  
 
Change in depressive symptoms 
Baseline to 6 months 

 
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2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the control 
cohort will have a 12-month assessment to collect the outcomes listed in the table above. To 
be as clear as possible - those items have been highlighted in green.  
 
Sequential description  
(see attached Study Flow Chart) 
 
ORIGINAL (in-person) COHORT 
1. 
Subjects are contacted by the KPWA survey research team and provide oral consent over 
the phone in the initial screening and eligibility process; if eligible and interested, subjects 
will be mailed an activPAL device along with instructions on how to wear it for one week 
and will be scheduled for their first/baseline visit at KPWHRI research clinic. 
 
2. 
COVID-19 UPDATE: BASELINE VISITS ARE CURRENTLY ON HOLD Subjects will 
attend a baseline screening visit at KPWHRI research clinic in downtown Seattle.  
a. At the baseline visit, prior to signing the consent form, the RS will ask the potential 
participant to recap briefly their understanding of the study. Once subjects have signed 
written, informed consent at the baseline visit they will have baseline measurements 
taken, including height, weight, waist circumference, physical function and blood 
pressure. They will have a small amount of blood collected by finger prick. They will 
turn in their activPAL device to the research specialist. They will also complete a 
survey containing self-reported scales regarding health symptoms (depressive 
symptoms, pain, fatigue), daily activities, and psychosocial mediators (e.g. habit 
strength, self-efficacy). All participants will receive a $40 incentive for completing 
measurements at the baseline visit. If participants inquire about their blood values or 
blood pressure, we will share the information with them but without interpretation and 
advise them to see their provider if they have questions or concerns. 
b. After baseline activPALs are returned, participants will be randomized (using a link 
created by the study biostatistician and programmer) to receive i-STAND (N = 142) or 
healthy lifestyle control (N = 142). To ensure that baseline sitting time is balanced, we 
will stratify participants into two groups based on self-reported sitting-time using 
median sitting time from our pilot work as a cut point: moderate (<8.5 hours/day) and 
high (≥8.5 hours/day). We will also stratify by obesity level (30-35 vs 35+kg/m2) and 
 
Change in physical function 
 
VDW 
Various chronic conditions (e.g. diabetes, cardiovascular 
conditions); lab values for HbA1c, cholesterol; blood 
pressure; blood pressure medications; height and weight; 
medical events (e.g. falls, hospitalizations, heart attack, 
stroke, blood clots); and, healthcare costs. 
One year prior to 
first Study Visit date 
to the end of the 
study for up to 5 
years after the study 
ends, no later than 
June 1, 2028 

 
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blood pressure (systolic BP over or under 130).  
 
c. After completing measurements, participants randomized to receive the i-STAND 
intervention condition will meet with a health coach and have an in-person coaching 
session (at Baseline Visit). During the first intervention session they will review a 
feedback chart depicting their daily sitting time, standing time, and breaks from sitting 
from the activPAL they wore for baseline. In the case that the coach encounters 
difficulty with the STATA software that creates the feedback chart output, coaches will 
use the raw activPAL data (does not take sleep hours out of the download) and share 
this with participants. They will explain the data in the same way they would if they 
were able to produce a feedback chart. Participants in the i-STAND cohort will receive 
the i-STAND study workbook, self-monitoring forms, and offered a wrist-worn 
prompting device (Fitness activity band), and a portable tabletop standing podium/desk 
to be used at home or work or wherever the participant chooses to use it (see i-
STAND Workbook for photos and instructions for both items) to cue breaks from 
sitting. The health coach will provide background information on how sitting could 
impact their health. The coach will review the feedback chart with the participant, 
provide reinforcement for times during the week when the participant took more breaks 
from sitting, assess and enhance participant motivation and uncover values (using 
motivational interviewing principles29,30) to inform developing an action plan to meet 
graded goals based on participant values. The action plan will include target goals, 
when/how/where tasks will be performed, strategies to overcome barriers, and how 
goals map to participant values. Discussion will cover principles of habit formation. The 
health coach will model taking breaks from sitting by inviting the participant to stand 
with them at least once during the session.  
 
During the in-person session, participants will be instructed in using the wrist-
worn activity band and standing desk to help remind them to take breaks from 
sitting. Our pilot work strongly supported the need for these cues. The band 
subtly vibrates to prompt a break at preselected intervals (ex: 15, 30 or 60 
minutes) and will be set to prompt every 15 minutes to remind them regularly to 
take breaks from sitting. Because many older adults don’t feel comfortable 
setting up technology and mobile tools, the device will be preset so it functions 
without syncing to another device. Participants who want to use the activity band 
smartphone application will receive additional instruction.  Study staff will not 
have access to any data from the device.  If any participants feel the frequency 
(every 15 minutes) is too much, study staff can re-set the band at a lower 
frequency based on the participants’ preference. 
 
Those who express interest in other features of the Fitness wrist band will be 
given a handout showing how to program the device to track other things (ex: 
steps taken, calories burned), however the study does not track on any of these 
features/options and the coach will remind the participant that the study is solely 
interested in whether they find the vibration reminders useful as an outward 
reminder to stand. (Usefulness will be measured in a 3-month survey (see 
section 3a next page). 
 
d. Participants in the Healthy Lifestyle Control group will meet with a health coach and 
have an in-person coaching session where they will review the Healthy Living 

 
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materials and choose topics of interest to focus on throughout the program. They will 
learn about how to set clear, actionable goals.  They will receive a Healthy Living 
workbook. The health coach will provide background information and help the 
participant choose topics of focus to inform developing an action plan to meet graded 
goals based on participant values. The action plan will include target goals, 
when/how/where tasks will be performed, strategies to overcome barriers, and how 
goals map to participant values.  
e. All participants will be asked by the health coach during the baseline visit to provide 
additional contact information. This will be collected on a separate sheet and will be 
entered into the ACCESS database used by the team.  
 
3. 
After the initial in-person session: 
a. All i-STAND participants will receive one more in-person session and 8 follow-up 
phone calls (10 contacts total) from their health coach over 6 months.  All participants 
will also be sent an activPAL to wear, as well as a survey, at the mid-point (Month 3) 
and will receive a $20 incentive for wearing the activPAL at month 3. All participants 
will receive a reminder phone call from the RS to confirm receipt of the packet 
containing the activPAL and the survey. If the packet was not received, the RS will 
resend another packet. At the 3-month mark, health coaches will also collect 
satisfaction data on use of the devices. This information will be collected over the 
phone and input into REDCap by the coaches, so as to avoid contaminating the survey 
data collected by the blinded research specialists, who will be managing the primary 
survey distribution and data collection. 
 
b. All Healthy Lifestyle Control Participants will receive 9 follow-up phone sessions after 
their initial in-person session (10 contacts total).  Each call will cover a topic of interest 
to the participant (see Table 4).  Relevant content from the Healthy Living workbook 
will be briefly reviewed and goals will be set. Follow-up calls will check-in with prior 
calls.  The calls will occur every 2-3 weeks over the first 6 months of the study.   
 
c. COVID-19 UPDATE: both i-STAND and Health Lifestyle participants will be offered, 
using an Addendum to Consent oral agreement, the option of additional coaching calls 
beyond the 10 sessions to occur on a monthly basis. See page 15 of this protocol for 
details and see the Addendum Consent for script. 3-month assessments will also still 
be mailed. A study RS will assemble packets with charged activPALs and participant 
surveys at their home and mail to participants via the USPS. Study RS has sanitation 
procedures that are used at the office that will also be used at home in assembling 
packets (gloved, wipes, etc). Participants will mail the packets back to KPWHRI and a 
study RS will be checking our mailbox once a week for returned devices/surveys. 
 
d. All participants (i-STAND and Healthy Lifestyles control group) will attend a 6-month 
measurement visit. A few weeks prior to the visit and to mailing the acctivPAL device 
to the participants, the RS will call the participant to ensure we have accurate contact 
information and to remind them of the upcoming timepoint. If the participant has 

 
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requested that scheduling visits/reminders of visits be done via email, this information 
will be sent via email from the RS.  The same measurements and assessments will be 
taken as at baseline except a study satisfaction questionnaire will be included in the 
self-reported survey. All participants will receive a $40 incentive for completing 
measurements at the 6 month visit.  For those participants who do not show up to their 
scheduled 6-month visit, we will attempt to reach them by phone and then by mail, 
encourage their participation and completion of this timepoint. At this in-person visit, if 
participants inquire about their blood values or blood pressure, we will share the 
information with them but without interpretation and advise them to see their provider if 
they have questions or concerns. After completing the 6-month measurement visit, all 
I-STAND participants will be re-randomized to EITHER receive i-STAND booster 
sessions (5 additional phone contacts) or no further intervention for 6 months. The 
health coach will call each participant after they complete their 6 month measurements 
to inform them of their assignment.   
 COVID-19 UPDATE: We will be ordering and sending directly to 
individual participants from a third party vendor (pending oral consent 
from participants) Omron BP Monitors (The Omron 3-Series BP7100 
model) for any 6 and 12-month measurements. Participants will not be 
expected to return this device. Instructions will be included in the mailed 
packet that also includes the survey, activPAL, paper measuring tape 
(Medline 72” paper measuring tape). RS staff will call participants to 
conduct the chair-sit measurement and to verbally collect the 
BP/weight/waist measurements from participants. As usual, study packets 
mailed to participants will include return envelopes for the activPALs and 
the surveys. 
 We will send incentives to participants when business returns to normal 
and we are able to send cash incentives. Participants will be notified that 
they will receive their incentives at a later time.  
 We have amended Supplement B to request permission to use email to 
send the link for the survey (REDCap) to participants for whom we have 
email addresses and who have given us permission to contact them using 
email. 
 We will track those participants who receive a device from a third party 
vendor on the internal PHI Disclosure Tracking Form 
(https://ghriweb01.ghc.org/disclosuretrack/seldisc1.aspx)   
e. For those re-randomized into the i-STAND group, 5 booster calls spread over 6 
months (about every 6 weeks) will focus on maintaining improvements (or continuing 
to improve for those who have not met goals), action planning, problem-solving, 
preventing relapse, and continuing to use previously learned skills and tools. 
f. 
Participants in the i-STAND booster arm will wear the activPAL for an interim week 
between measurement visits (i.e., at 9 months) and receive an additional feedback 
chart to help monitor progress towards goals.  
COVID-19 UPDATE: Until we return to normal business, this intervention activPAL 
wear has been temporarily suspended.  

 
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g. Participants in the i-STAND booster arm will receive a supplemental survey at 9-month 
mark to gauge their use of the tools – the standing desk and the Fitness wrist-band.  
COVID-19 UPDATE: Until we return to normal business, this intervention survey has 
been temporarily suspended. 
 
4. 
All participants (i-STAND and healthy living control group) will attend a final, 12-month 
measurement visit. Prior to the visit they will be mailed an activPAL to wear for a week. 
The same measurements will be taken as at baseline and at the 6-month visit, including a 
survey. All participants will receive a $40 incentive for completing measurements at the 12 
month visit. i-STAND cohort participants will be allowed to keep their wrist bands and 
standing desks. Once again, at this in-person visit, if participants inquire about their blood 
values or blood pressure, we will share the information with them but without interpretation 
and advise them to see their provider if they have questions or concerns. 
COVID-19 Update – see 3c. above for details 
 
5. 
Shortly after completing the active, 6-month phase of the study, participants will receive a 
call asking for their oral consent to an interview. After completing the full year in the study 
including the final, 12-month visit, they will receive a letter thanking them for their 
participation and inviting them to participate in a final exit interview in the coming months. 
The letter will provide an opt-out if they do not want to do an exit interview. If we do not 
hear from the participant, we will assume they are open to receiving an exit interview 
phone call.).  
 
 
REMOTE (phone) COHORT 
1. 
Subjects are contacted by the KPWA survey research team and provide oral consent 
over the phone in the initial screening and eligibility process; if eligible and interested, 
will be notified to expect a call from a research specialist to schedule their baseline 
phone visit. Survey research team mails consent form and welcome letter.  
 
 
2. 
About 1 week after survey has mailed consent,  and up to two weeks before the baseline 
phone visit, the research specialist (after confirming that the participant has the consent 
form in front of them) will review over the phone with the subject the written informed 
consent form (see attached) and describe the study to them, answer any questions, and 
obtain either written or online consent. If the participant is willing to consent online, after 
discussing the consent process and reviewing the consent materials, the RS will email a 
link to a REDCap form (see email script) with an online consent for the participant to 
electronically sign. If in written form, the participant will mail the form back to KPWHRI 
and a copy will be made and sent back out to the participant ideally within 2 weeks of 
receipt. The RS will also ask the subject to summarize the study to the best of their 
ability. If they are unable to do so or cannot recall the primary parts of the study (ex: that 
they have to wear a device periodically; that they will have coaching calls; that they will 

 
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be randomly assigned to one of two groups), they will be thanked for their time and 
excused from the study prior to randomization. During this phone call, the RS will also 
collect height and weight to ensure we send them the right size cuff along with their 
blood pressure monitor to ensure accuracy.  
 
3. 
The research specialist will prepare and mail a packet to the potential participant 
including an activPAL device along with instructions on how to wear it for one week. The 
research specialist will order a scale (and measuring tape) to be sent to the participant 
as well as a blood pressure monitor. Instructions will be included. Envelopes for 
returning the activPAL device are also included. 
 
4. 
Subjects will participate in a baseline phone visit approximately 30 days after initial 
screening into the study by the survey research group and roughly 2 weeks after their 
phone consent. 
a. During the baseline phone visit, participants will either complete a survey containing 
self-reported scales regarding health symptoms (depressive symptoms, pain, fatigue), 
daily activities, and psychosocial mediators (e.g. habit strength, self-efficacy) with the 
research specialist or will complete the survey online (their preference). Participants 
will be guided through collecting their waist measurement, weight and blood pressure 
using the devices and tools sent ahead of time. Per instructions and reminders sent to 
participants, if they have consumed any caffeine or tobacco, or exercised within 30 
minutes of the visit, the visit will be rescheduled. Participants will also be guided 
through the modified chair sit over the phone. All participants will be mailed a $30 cash 
incentive  for completing measurements at the baseline visit. If participants inquire 
about their blood pressure readings, we will advise them to see their provider if they 
have questions or concerns.  
b. After baseline activPALs are received by mail, coaches will download the data and 
participants will be randomized (using a link created by the study biostatistician and 
programmer) to receive i-STAND (N = 142) or healthy lifestyle control (N = 142). To 
ensure that baseline sitting time is balanced, we will stratify participants into two 
groups based on self-reported sitting-time using median sitting time from our pilot work 
as a cut point: moderate (<8.5 hours/day) and high (≥8.5 hours/day). We will also 
stratify by obesity level (30-35 vs 35+kg/m2) and blood pressure (systolic BP over or 
under 130). Coaches will call participants to notify them of their assigned cohort and to 
schedule their baseline coaching visit. At this time they will also confirm if they prefer 
to use email or regular mail.  
 
c. Participants who were randomized to i_STAND and did not give us their email, will 
have their first feedback chart mailed to them, along with instructions (see attached) on 
how to retrieve encrypted emails in the future, in case they prefer to receive their 
feedback chart by email going forward. All other i-STAND participants who have given 
us permission to email, will have their charts sent via encrypted email as described in 
Supplement B. Because it does not require encryption, if the participant has expressed 
over the phone that they prefer to receive study materials by email, the i-STAND 
workbook will be sent by email at this time. If not, the notebook will be mailed by 
USPS. A fitness activity band will also be mailed from a third party vendor and a 

 
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standing desk. NOTE: We have amended Supplement B to request permission to send the 
activPAL feedback chart to i-STAND only participants  (as an alternative option to sending 
them by mail).  
 
 
d. Within two weeks of completing the phone-based baseline measurements, participants 
randomized to receive the i-STAND intervention condition will have their first phone 
coaching session with their health coach. During the first intervention session they will 
review the feedback chart they were mailed which depicts their daily sitting time, 
standing time, and breaks from sitting from the activPAL they wore for baseline. In the 
case that the coach encounters difficulty with the STATA software that creates the 
feedback chart output, coaches will use the raw activPAL data (does not take sleep 
hours out of the download) and share this with participants. They will explain the data 
in the same way they would if they were able to produce a feedback chart. The health 
coach will provide background information on how sitting could impact their health. The 
coach will review the feedback chart with the participant, provide reinforcement for 
times during the week when the participant took more breaks from sitting, assess and 
enhance participant motivation and uncover values (using motivational interviewing 
principles29,30) to inform developing an action plan to meet graded goals based on 
participant values. The action plan will include target goals, when/how/where tasks will 
be performed, strategies to overcome barriers, and how goals map to participant 
values. Discussion will cover principles of habit formation. The health coach will model 
taking breaks from sitting by inviting the participant to stand with them at least once 
during the phone session.  
 
During the phone session, participants will be instructed in using the wrist-worn 
activity band and standing desk they were sent, to help remind them to take 
breaks from sitting. Our pilot work strongly supported the need for these cues. 
The band subtly vibrates to prompt a break at preselected intervals (ex: 15, 30 
or 60 minutes) and will be set to prompt every 15 minutes to remind them 
regularly to take breaks from sitting. Because many older adults don’t feel 
comfortable setting up technology and mobile tools, the device will be preset so 
it functions without syncing to another device. Participants who want to use the 
activity band smartphone application will receive additional instruction.  Study 
staff will not have access to any data from the device.  If any participants feel 
the frequency (every 15 minutes) is too much, study staff can re-set the band at 
a lower frequency based on the participants’ preference. 
 
Those who express interest in other features of the Fitness wrist band may 
receive a handout by email or mail showing how to program the device to track 
other things (ex: steps taken, calories burned), however the study does not track 
on any of these features/options and the coach will remind the participant that 
the study is solely interested in whether they find the vibration reminders useful 
as an outward reminder to stand. (Usefulness will be measured in a 3-month 
survey (see section 3a next page). 
 
e. Participants in the Healthy Lifestyle Control group will have their first phone-based 
coaching session where they will review the Healthy Living materials, go over in brief 
the first 5 topics, and advise the participant that after session 5, they can choose topics 

 
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of interest to focus on for the rest of the program. They will learn about how to set 
clear, actionable goals.  As with the i-STAND group, if we have their email and their 
willingness to receive study materials by email, we will email them the Healthy Living 
workbook. Otherwise this will be sent by mail prior to the first call. The health coach 
will provide background information and help the participant choose topics of focus to 
inform developing an action plan to meet graded goals based on participant values. 
The action plan will include target goals, when/how/where tasks will be performed, 
strategies to overcome barriers, and how goals map to participant values.  
f. 
All participants will be asked by the health coach during the baseline visit to provide 
additional contact information. This will be collected on a separate sheet and will be 
entered into the ACCESS database used by the team.  
 
5. 
After the initial baseline phone coaching session: 
a. All i-STAND participants will receive 9 follow-up phone calls (10 contacts total) from their 
health coach over 6 months.  An optional activPAL wear for i-STAND participants will 
take place at the 6-week mark, after which their data will be reviewed on a subsequent 
coaching call.  
2022 BUDGET CUT UPDATE: As of March 31, 2022, we are no longer offering the 
optional 6-week wear as a part of our staff time adjustments  
 
b. All Healthy Lifestyle Control Participants will receive 9 follow-up phone sessions after 
their initial baseline phone coaching session (10 contacts total).  Each call will cover a 
topic from the workbook (see Table 4).  Relevant content from the Healthy Living 
workbook will be briefly reviewed and goals will be set. Follow-up calls will check-in with 
prior calls.  The calls will occur every 2-3 weeks over the first 6 months of the study.   
c. All study participants will be sent an activPAL to wear, as well as a survey, at the mid-
point (Month 3) and will participate in a 3-month measurement visit by phone with a 
research specialist, repeating the measurements and instructions from the baseline visit. 
If the participant has requested that scheduling visits/reminders of visits be done via 
email, this information will be sent via email from the RS.  They will receive by mail a $30 
incentive for completing the 3-month visit. All participants will receive a reminder phone 
call from the RS to confirm receipt of the packet containing the activPAL and the survey. 
If the packet was not received, the RS will resend another packet. At the 3-month mark, 
health coaches will also collect satisfaction data from the i-STAND group on their use of 
the devices. This information will be collected over the phone and input into REDCap by 
the coaches, so as to avoid contaminating the survey data collected by the blinded 
research specialists, who will be managing the primary survey distribution and data 
collection. 
 
d. All participants (i-STAND and Healthy Lifestyles control group) will participate in a 6-
month phone-based measurement visit. If the participant has requested that scheduling 
visits/reminders of visits be done via email, this information will be sent via email from 
the RS.  The same measurements and assessments will be taken as at baseline and 3-

 
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months except a study satisfaction questionnaire will be included in the self-reported 
survey. All participants will receive a $30 incentive for completing measurements at the 6 
month phone visit.  After completing the 6-month measurement visit, all I-STAND 
participants will be re-randomized to EITHER receive i-STAND booster sessions (5 
additional phone contacts) or no further intervention for 6 months. The health coach will 
call each participant after they complete their 6 month measurements to inform them of 
their assignment.   
2022 BUDGET CUT UPDATE: As of March 31, 2022, there will be no re-
randomization at the 6-month timepoint for those in the i-STAND cohort. Their 
coaching will end after the 10 initial sessions.  
e.  
 We have amended Supplement B to request permission to use email to 
send the link for the survey (REDCap) to participants for whom we have 
email addresses and who have given us permission to contact them using 
email. 
 We will track those participants who receive a device from a third party 
vendor on the internal PHI Disclosure Tracking Form 
(https://ghriweb01.ghc.org/disclosuretrack/seldisc1.aspx)   
f. 
For those re-randomized into the i-STAND group, 5 booster calls spread over 6 months 
(about every 6 weeks) will focus on maintaining improvements (or continuing to improve 
for those who have not met goals), action planning, problem-solving, preventing relapse, 
and continuing to use previously learned skills and tools. 
g. Participants in the i-STAND booster arm will have the option to wear the activPAL for an 
interim week between measurement visits (i.e., at 9 months) and receive an additional 
feedback chart to help monitor progress towards goals.  
h. Participants in the i-STAND booster arm will receive a supplemental survey at 9-month 
mark to gauge their use of the tools – the standing desk and the Fitness wrist-band.  
2022 BUDGET CUT UPDATE: As of March 31, 2022, and due to the removal of the 
re-randomization stage for the i-STAND cohort taking place at 6-months (bullet 
“f”), there will be no further boosters. At 9-months, there will be no optional 9-
month activPAL wear (bullet “g”) nor will there be a 9-month supplemental survey 
(bullet “h”.  
 
6. 
All participants (i-STAND and healthy living control group) will participate in a final, 12-
month phone-based measurement visit. Prior to the visit they will be mailed an activPAL to 
wear for a week. The same measurements will be taken as at baseline, 3 and 6 months,  
including a survey. All participants will receive a $30 incentive for completing 
measurements at the 12 month visit. i-STAND cohort participants will be allowed to keep 
their wrist bands and standing desks. Once again, at this phone visit, if participants inquire 
about their blood pressure, we will advise them to see their provider if they have questions 
or concerns. 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort 
nor the control cohort will have a 12-month assessment. As such, there is no $30 

 
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incentive for completing a 12-month visit. This will be explained in the informational 
letter sent to participants.  
 
7. 
For those participants who miss their scheduled 3, 6 or 12 measurement visits, we will 
attempt to reach them by phone and then by mail, encourage their participation and 
completion of that timepoint. 
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort 
nor the control cohort will have a 12-month assessment 
 
 
8. 
Shortly after completing the active, 6-month phase of the study, participants will receive a 
call asking for their oral consent to an interview. After completing the full year in the study 
including the final, 12-month visit, they will receive a letter thanking them for their 
participation and inviting them to participate in a final exit interview in the coming months. 
The letter will provide an opt-out if they do not want to do an exit interview. If we do not 
hear from the participant, we will assume they are open to receiving an exit interview 
phone call.).  
2022 BUDGET CUT UPDATE: As of March 31, 2022, we will no longer be conducting exit 
interviews at the 6-month timepoint. And, as neither the i-STAND cohort nor the control cohort 
will have a 12-month assessment there will be no exit interview after this timepoint either. 
Table 4. Healthy Lifestyle Topics 
1. Coping with the Pandemic 
2. Insomnia and Sleep 
3. Stress & Anxiety 
4. Low Mood & Aging 
5. Healthy Eating & Hydration 
Healthy Bones & Osteoporosis 
Arthritis & Healthy Joints 
Bladder Control 
Preventing Falls 
Stress & Anxiety  
Writing an Advance Directive 
Immunizations & Screenings 
Managing your Medicines 
Chronic Pain 
Emergency Food & Water Supplies 
Goal Setting & Tracking Progress 
Communicating with Physicians 
 
PARTICIPANT COMPLETION 
ORIGINAL COHORT 
1. Participants who completed all in-person visits will receive a completion certificate and a 

 
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$40 bonus for completing all visits ($180 total).  
a. 
Participants in both groups may receive the workbook from the condition they did 
not receive and a summary of their activPAL data at the end of the study if they are 
interested. 
2. Once study results are available, a summary document of study findings will be prepared 
and shared with all participants. 
 
 
REMOTE COHORT:  
1. Participants who completed all phone visits will receive a completion certificate and a 
$30 bonus for completing all visits ($150 total).  
2022 BUDGET CUT UPDATE: As of March 31, 2022, there will no longer be a 12-
month visit, so the the new total amount is $120. We will continue to give a $30 
bonus for completing the other timepoints (Baseline, 3 and 6 months).  
a. 
Participants in both groups may receive the workbook from the condition they did 
not receive and a summary of their activPAL data at the end of the study if they are 
interested. 
2. 
Once study results are available, a summary document of study findings will be prepared 
and shared with all participants. 
 
ORIGINAL (in-person) COHORT 
Additional information about assessments and measurements at in-person visit (baseline, 6 and 12 
months): 
Cardiometabolic biomarkers: We will measure HbA1c. To measure HbA1c, we will obtain a capillary 
whole blood sample obtained by finger prick, collected in a toothpick-sized capillary tube, and analyzed 
immediately using the Siemens DCA Vantage Analyzer. It performs a CLIA-waived HbA1c test that is 
IFCC and NGSP-certified. 
 
Potential incidental findings may include a discovery that the participant has Diabetes. If this is 
discovered, the physician on call will notify the research specialist who will advise the participant to 
meet with their primary care provider as soon as possible.  
Weight, Height, Waist. Weight will be measured using a calibrated Seca Digital weight scale. Height 
will be measured using a calibrated Seca Digital Stadiometer. Waist circumference will be measured 
twice at the superior border of the iliac crest and the average of two measurements used.31   
COVID-19 UPDATE: remote weight measurement at 6 and 12-months (until normal business resumes) 
will be collected as available and depends on the participant having a scale at home. Waist 
circumference will be collected using a Medline brand paper measuring tape which will be sent ahead 
of time to participants along with instructions on how to take an accurate measurement. 
Blood Pressure: We will measure blood pressure (systolic and diastolic) three times to ensure accurate 
results. BP will be measured using an OMRON Digital BP Monitor with Intellisense. Model 
HEM907XL.We will also advise participants to avoid caffeine, tobacco and exercise in the 30 minutes 

 
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prior to the visit to ensure accuracy. After consent and when scheduling the baseline visit, we will ask 
the participant for height and weight so we can plan to send them the right size cuff with their BP 
monitor.  
 
COVID-19 UPDATE: Until we return to normal business, we will be mailing Omron 3-Series BP7100 
monitors (along with cuff and instructions on use) from a third party vendor (pending oral consent from 
the participant). These were recommended as a good option for home monitoring by Co-I Bev Green, 
MD who has an expertise in blood pressure. Study measurement of blood pressure using these devices 
will be conducted during a phone call with the study Measurement RS, allowing for verbal instructions 
and questions from participants about the proper use of the device.   
Demographics: Age, sex, education, marital status, race/ethnicity, retirement status, and other 
pertinent demographics will be measured using self-reported items on the baseline survey. Some 
demographic variables will be used as covariates in analyses. 
Psychosocial and environmental measures: We will measure self-efficacy based on modifying 
measures that were developed in youth and adults (since none exist for older adults)32-35 and habit 
formation which will be assessed using a modification of the Self-Report Habit Index36 (e.g., "sitting is 
something I do without thinking").  
COVID-19 UPDATE: We have added new sections to the surveys with validated instruments to better 
assess participant psychosocial status in the current environment. This includes lower extremity items 
from the Late-Life Function and Disability Instrument (LLFDI) for physical function; Generalized Anxiety 
Disorder Assessment (GAD-2) and the Perceived Stress Scale (PSS) for stress/anxiety; and COVID-19 
impact. As always, participants can choose not to answer questions on the survey that make them 
uncomfortable.  This information will be used by the statistician to determine whether any of the 
COVID-19 related variables are moderators of the interventions. 
Physical function. The Short Physical Performance Battery (SBBP) will objectively evaluate lower 
extremity function with tasks for balance, gait speed, and lower-extremity strength (chair rise).37,38 Gait 
speed significantly improved in our prior study.1 SPPB will also be a covariate as it is associated with 
sedentarism.39 
COVID-19 UPDATE: Until we resume normal business, we will only be able to measure the chair rise 
as part of a remote assessment. The study RS will provide instructions and guidance to the participant 
via phone in order to conduct this measure remotely.  
Other behavior changes. We will explore other activPAL metrics including sit-to-stand transitions, 
standing time, and step counts (as a measure of total physical activity). The same data-processing 
techniques will be used for these outcomes as for activPAL-measured sitting time. Self-reported 
sedentary behaviors will be assessed with the Sedentary Behavior Questionnaire to understand what 
types of sedentary behaviors are amenable to change. This measure has acceptable test-retest 
reliability and convergent validity.40 
Quality of life will be measured with the PROMIS Global Quality of Life Scale The Patient Health 
Questionnaire-8 will assess depressive symptoms and levels improved in our pilot work.1,41  

 
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REMOTE (phone) COHORT:  
 
Additional information about assessments and measurements at in-person visit (baseline, 3, 6 and 12 
months): 
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the control 
cohort will have a 12-month assessment 
Cardiometabolic biomarkers: None 
 
Weight, Height, Waist. Weight will be measured using the EtekcityEB9380H scale sent to participants 
from Amazon. The scale comes with a tape measure.  Waist circumference will be measured twice at 
the superior border of the iliac crest and the average of two measurements used using instructions on 
how to take an accurate measurement sent by the research specialist.31   
 
Blood Pressure: We will measure blood pressure (systolic and diastolic) three times to ensure accurate 
results. BP will be measured using the Omron 3-Series BP7100 monitors, sent to the participant (along 
with cuff and instructions on use) from a third party vendor. Study measurement of blood pressure 
using these devices will be conducted during a phone call with the study Measurement RS, allowing for 
verbal instructions and questions from participants about the proper use of the device, including to 
avoid caffeine, tobacco and exercise in the 30 minutes prior to the visit to ensure accuracy. 
.   
Demographics: Age, sex, education, marital status, race/ethnicity, retirement status, and other 
pertinent demographics will be measured using self-reported items on the baseline survey. Some 
demographic variables will be used as covariates in analyses. 
Psychosocial and environmental measures: We will measure self-efficacy based on modifying 
measures that were developed in youth and adults (since none exist for older adults)32-35 and habit 
formation which will be assessed using a modification of the Self-Report Habit Index36 (e.g., "sitting is 
something I do without thinking"). We have also included validated instruments to better assess 
participant psychosocial status in the current environment. This includes lower extremity items from the 
Late-Life Function and Disability Instrument (LLFDI) for physical function; Generalized Anxiety Disorder 
Assessment (GAD-2) and the Perceived Stress Scale (PSS) for stress/anxiety; and COVID-19 impact. 
As always, participants can choose not to answer questions on the survey that make them 
uncomfortable.  This information will be used by the statistician to determine whether any of the 
COVID-19 related variables are moderators of the interventions. 
Physical function. We will measure the chair rise sub-scale of the Short Physical Performance Battery 
as part of the remote assessments. The study RS will provide instructions and guidance to the 
participant via phone in order to conduct this measure remotely.  
Other behavior changes. We will explore other activPAL metrics including sit-to-stand transitions, 
standing time, and step counts (as a measure of total physical activity). The same data-processing 
techniques will be used for these outcomes as for activPAL-measured sitting time. Self-reported 

 
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sedentary behaviors will be assessed with the Sedentary Behavior Questionnaire to understand what 
types of sedentary behaviors are amenable to change. This measure has acceptable test-retest 
reliability and convergent validity.40 
Quality of life will be measured with the PROMIS Global Quality of Life Scale The Patient Health 
Questionnaire-8 will assess depressive symptoms and levels improved in our pilot work.1,41  
 
Device information 
The activPAL (PAL Technologies Ltd, Glasgow, UK) is currently the most valid objective measurement 
of sitting time as it differentiates sitting from standing using an inclinometer and proprietary software to 
calculate time spent sitting/lying, standing, stepping, and number of sit-to-stand transitions.42,43 This 
device has been used with older adults,44 is sensitive to change1,45 and has high validity in comparison 
to direct observations.42,46,47 It is considered more valid for measuring sitting time and breaks from 
sitting than Actigraph or Actiheart accelerometers. 47,48 We will use the activPAL micro which is 
unobtrusive, very light (10 grams), 5 mm thick, and worn on the thigh using a waterproof medical 
adhesive (TegadermTM) that does not require skin preparation such as shaving. The device does not 
have to be removed. The research specialist will train participants in how to attach and replace the 
activPAL in the event the dressing becomes compromised or if skin irritation occurs. This training will 
ensure that I-STAND participants are able to independently apply the activPAL to their leg for interim 
activPAL wear.  The device has worked well in Dr. Rosenberg’s sub-study of over 1100 older adults 
enrolled in Dr. Larson’s Adult Changes in Thought Study.  Very few reports of difficulties or skin 
irritation have occurred.  
 
The Fitness activity tracking band will be offered to i-STAND participants (not to the attention control 
group) for activity prompts at selected intervals. Participants can choose at any time to not use the 
band (some may not find the reminders useful). No data will be collected from the activity band itself. It 
is solely used as a prompting device for 15-minute reminders to stand. 
 
 
 
Direct identifiers that will be collected or included in the analytic data files, the linking file, or other study 
records (e.g., recruitment records, intervention files) at KP Washington. 
DIRECT IDENTIFERS 
 Names 
 Dates 
 Postal address  
 Geocode  
 Phone numbers
 Fax numbers 
 Email address 
 Social Security Numbers 
 Medical record numbers 
 Health plan numbers 
 Account numbers 
 License/Certificate numbers 
 Vehicle ID numbers 
 Device identifiers/Serial numbers 
 Web URLs 
 IP address numbers 
 Biometric identifiers (e.g., 
finger prints, voice prints, 
retina scans) 
 Facial Photos/Images 
 CHS ID 
 Other unique identifier(s): 
 
 

 
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Attention Control group:  
ORIGINAL (in-person) COHORT:  
This intervention was designed to control for a similar amount of contact time and attention, nonspecific 
treatment effects, study satisfaction, and patient expectations. Attention controls have been used in 
previous physical activity intervention trials among older adults for whom time, attention, and social 
support may be particularly salient factors that affect study outcomes.49,50 Attention control participants 
will receive the same number of contacts as i-STAND participants and a study workbook with general 
healthy living content based on the usual care available to KP members. During the initial in-person 
session, participants will choose up to 9 topics from a list of 17 to review with their health coach during 
subsequent sessions (see Table 2). The content provided will not include any information that could 
impact sitting time or physical activity. During the 9 follow-up calls, the health coach will review 
progress towards prior goals, engage participants in brief discussions of the session topic, and set 
goals for new topics. All health-related content included in the workbook and delivered by the health 
coach is currently available online to KP members and is reviewed and updated regularly by KP 
physicians. The attention control group will receive no further intervention after the 6-month 
measurement visit. 
REMOTE (phone) COHORT:  
This intervention was designed to control for a similar amount of contact time and attention, nonspecific 
treatment effects, study satisfaction, and patient expectations. Attention controls have been used in 
previous physical activity intervention trials among older adults for whom time, attention, and social 
support may be particularly salient factors that affect study outcomes.49,50 Attention control participants 
will receive the same number of contacts as i-STAND participants and a study workbook with general 
healthy living content based on the usual care available to KP members. During the initial phone 
session, participants will review with their coach the first 5 topics (topics for Sessions 1-5 are assigned 
to the participant). After the first 5 sessions, the participant can choose and additional 5 topics that 
interest them for Sessions 6 – 10 (see Table 2). The content provided will not include any information 
that could impact sitting time or physical activity. During the 9 follow-up calls, the health coach will 
review progress towards prior goals, engage participants in brief discussions of the session topic, and 
set goals for new topics. All health-related content included in the workbook and delivered by the health 
coach is currently available online to KP members and is reviewed and updated regularly by KP 
physicians. The attention control group will receive no further intervention after the 6-month 
measurement visit. 
 
 
Blinding (incomplete disclosure): Health coaching training, fidelity, and tracking.  
Health coaches will be trained and supervised by Dr. Rosenberg, a licensed clinical psychologist who 
has training in motivational interviewing, cognitive behavioral therapy, acceptance and commitment 
therapy, and behavioral activation. Training for coaches will include 8 hours of didactic information on 
principles of coaching, motivational interviewing, and the behavioral strategies to be employed in each 
condition. Coaches will receive detailed intervention phone scripts for each condition to enhance fidelity 
to intervention content. Coaches will undergo thorough practice of in-person and phone sessions 
including a final evaluation with attention control or i-STAND practice patients. To enhance fidelity, all 
phone calls will be audio-recorded and a random 10% will be reviewed by Dr. Rosenberg for content 

 
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coverage using a study-specific checklist. Any deviations from protocol will be rectified during health 
coach supervision which will occur weekly (separately). Participants identified as having any concerning 
physical or mental health issues will be called by Dr. Rosenberg or Drs. Arterburn or Green, the study 
physicians, who will seek participant permission to notify the participant’s primary care physician of the 
concerns through the KPWA secure messaging system. All participant intervention contacts will be 
tracked using a tailored Microsoft Access database developed by a programmer. The Health Coaches 
will not be blinded.  Only the research specialist will be blinded. The blinded research specialist who 
conducts measurements will not have access to the intervention tracking database. 
 
As described on page 12 of this protocol, there is some blinding/incomplete disclosure to participants 
during the consent process.  
 
Procedures to monitor, lessen or mitigate risk 
Use of KP Consulting Nurse Service as needed 
Physician on call  
Participants will be fully informed about the study  
Risk of breach of privacy described further in section 5.f. 
Risk of breach of security described further in section 7. 
Data Safety Monitoring Plan in place: See DSMP for protocols around concerning health (mental and 
physical) risks as well as elevated BP, HbA1c. 
 
 
 
 
Subject drop out or withdrawal procedures 
ORIGINAL (in-person) COHORT:  
At any time, subjects can opt out of the study. Anyone who wishes to drop out will be called by their 
health coach to determine if they are still willing to provide measurement data, and a letter will be sent 
relevant to the timepoint in question. A participant may be dropped from the study if they state during 
the course of the study that they can no longer participate in calls and/or visits (for instance if they 
move). Participants may also be dropped if at some point their health has deteriorated to a point where 
their participation is no longer optimal (we are recruiting participating up to age 89 so some decline in 
general health as a result of age may occur during the year-long participation. This will result in the 
participant no longer being able to participate. This determination will be made by the PI. This is also 
described in the consent form. 
 
REMOTE (phone) COHORT:  
At any time, subjects can opt out of the study. Anyone who wishes to drop out will be called by their 
health coach to determine if they are still willing to provide measurement data, and a letter will be sent 
relevant to the timepoint in question. A participant may be dropped from the study if they state during 
the course of the study that they can no longer participate in calls. Participants may also be dropped if 
at some point their health has deteriorated to a point where their participation is no longer optimal (we 
are recruiting participating up to age 89 so some decline in general health as a result of age may occur 
during the year-long participation. This will result in the participant no longer being able to participate. 
This determination will be made by the PI. This is also described in the consent form. 
 
 

 
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Anticipated study end date 
We anticipate completing all subject visits/phone calls by June 30, 2022. COVID-19 UPDATE: We 
anticipate this date extending to December 2022. We have notified our NHLBI program officer. 
 
 
 
 
a. Data Analysis  
Describe the data analysis plan, including: 
 
Statistical procedures.  
 
When applicable, the power analysis.  
 
Any procedures that will be used for quality control of collected data. 
 
FOR BOTH ORIGINAL AND REMOTE COHORTS: We will add secondary analyses to address 
changes due to COVID-19. 
Preliminary analyses. The statistician will be blinded to intervention condition and intent-to-treat 
analyses will be performed. Before analysis, data will be cleaned and checked for out-of-range and 
invalid values. We will examine the distribution of baseline covariates across groups to evaluate 
balance by randomization assignment. Further, we will compare follow-up rates by group assignment 
along with assessing for imbalance of baseline covariates by intervention group in the subset with 
follow-up outcome measures. Given the large sample size, we expect that between-group differences 
will be small. However, if factors differ by group at baseline, we will adjust for them in the final analyses 
or use them in imputation analyses if we have a larger than expected dropout rate. All analyses will be 
based on the “intent-to-treat” principle. Regardless of actual intervention participation, outcomes will be 
analyzed using the group to which participants were randomly assigned. We will also attempt to obtain 
follow-up data from all participants, regardless of participation level. 
Aim 1: Determine the efficacy of i-STAND to improve primary and secondary outcomes at 6 months.   
Primary Outcome Analysis: Our primary outcomes are change from baseline in mean daily sitting time 
and systolic and diastolic blood pressure (described in Section C12). We will compare group means for 
our primary outcomes between participants randomized to i-STAND versus attention control using 
linear regression with generalized estimating equations (GEEs) including both outcome time points at 3 
and 6 months. GEE is used to account for multiple outcomes measured on the same study participant 
along with relaxing the normality assumption that standard linear regression methods require.51 We will 
adjust for baseline covariates including participant age, sex, physical function, and respective baseline 
outcomes with other covariates that are imbalanced in preliminary analyses. If dropout is above 15%, 
we will employ imputation techniques to address missing data issues.52 However, our focus will be on 
minimizing dropout rates. Analyses for secondary outcomes including lipids, fasting glucose, weight, 
and waist circumference will be similar, adjusting for respective baseline outcomes in the analysis.  Aim 
2: Determine the maintenance of sitting and blood pressure reductions over 12 months. We will conduct 
a sequential series of analyses using a similar statistical framework as outlined for Aim 1, but using 12-
month follow-up data. We will first run a regression model with three groups (attention control, i-STAND 
no boosters, and i-STAND with boosters) including baseline covariates as outlined above. We will then 

 
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assess differences in primary outcomes at 12 months in the two i-STAND groups: with and without the 
booster intervention. If a significant difference in a given primary outcome is found in sitting time at 12 
months between the i-STAND booster versus no booster groups (Scenario 1), we will further compare 
the i-STAND booster and no booster groups to the attention control group. Scenario 1 assessments will 
determine if i-STAND with boosters is better than i-STAND without boosters and if either or both I-
STAND groups are better than attention control at 12 months.  
If i-STAND groups do not differ at 12 months (Scenario 2), we will combine i-STAND groups and run a 
second regression model on each 12-month outcome including only attention control and i-STAND. If 
this regression shows that i-STAND has lower sitting time and/or blood pressure than attention control, 
we will conclude that the i-STAND intervention improved sitting time and/or blood pressure over 12 
months, but boosters were not shown to be efficacious. We will conduct a similar analysis for 
secondary cardiometabolic risk marker outcomes. 
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the control 
cohort will have a 12-month assessment, so we are removing Aim 2.  However, we will still 
explore maintenance of sitting and blood pressure reductions over 12-months for future grants and pilot 
data purposes.  
Aim 3:  Explore moderators (e.g., age, sex, baseline physical activity) and mediators of reductions in 
sitting time (e.g., psychosocial variables) and cardiometabolic risk factors (e.g., changes in sitting time 
and/or physical activity). Exploratory analyses will assess moderators of the intervention effect by 
including interactions with baseline variables such as age, sex, and physical activity level to determine 
if a subset of the population might be the best target for dissemination of the i-STAND intervention. If i-
STAND is efficacious in reducing sitting time and/or blood pressure, we will also conduct mediator 
analyses53 to explore whether psychosocial or behavioral variables mediate the reduction in sitting time 
and/or blood pressure. All mediator analyses will only include mediators that are measured at time 
points prior to the outcome time measurement (e.g., 3-month mediators for 6-month outcomes) to 
assess for causal mediation relationships. We will take a forward stepped approach to assess 1) if a 
potential mediator is a mediator without including other potential mediators (bivariate mediator), and 
then 2) a multiple mediator analysis including all bivariate mediators in the model.54 This will allow us to 
assess if the mediation is independent of, or in combination with, other mediators. Finally, if i-STAND is 
efficacious in changing secondary cardiometabolic risk factors, we will explore whether reduced sitting 
time mediated these changes independent of increased physical activity. This analysis will provide 
important novel information on whether reduced sitting, regardless of changes in physical activity, can 
truly improve health among obese older adults.          
Additional exploratory analyses: We will explore whether i-STAND improves standing time, breaks from 
sitting, physical activity (step counts), quality of life, physical function, and depressive symptoms. 
Further, per protocol analyses amongst those that adhered to the intervention will also be conducted. 
These analyses will use similar models as described for Aim 1 analyses.  
Power calculations. Our sample size of 284 ensures 90% power to detect a difference in the reduction 
of sitting time between i-STAND and attention control of 41 minutes at 6 months (primary time point). 
Given our pilot results and i-STAND’s long-term goal target of a 2 hour reduction in sitting time, a 
difference in sitting time reduction of 41 minutes is achievable. We assumed a standard deviation (SD) 

 
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in change in sitting time of 97 minutes/day based on I-STAND pilot RCT data, a pooled sample t-test, 
and a 15% loss to follow-up under which we would observe 241 participants at 12 months. Further, this 
sample size provides 90% power to detect a difference of 6.2 mmHg change in systolic (14.7 SD) and 
4.0 mmHg change in diastolic (9.5 SD) blood pressure. We are powered for comparable reductions in 
blood pressure as those observed in walking and exercise55,56 interventions (5-10 change in systolic 
and 1-6 mmHg change in diastolic blood pressure)57. Therefore, we are powered to achieve a minimal 
clinically important difference for blood pressure outcomes.58 
 
 
For Aim 2, we will have 90% power to detect a 58-minute difference in sitting time between i-STAND 
with boosters compared to i-STAND without boosters at 12 months. Further, given Scenario 2 in which 
i-STAND boosters is not different than i-STAND without boosters we will have 90% power to detect a 
41-minute difference in sitting time with combined I-STAND groups. Given Scenario 1, in which i-
STAND with boosters is significantly different from i-STAND without, at 12 months, we will have 90% 
power to detect a 50-minute difference in sitting time between either i-STAND group and the attention 
control. For blood pressure outcomes, we have 90% power to detect an 8.8 mmHg change in systolic 
blood pressure and 5.7 mmHg change in diastolic blood pressure when comparing i-STAND groups 
(booster vs. no booster) at 12 months. Therefore, this study is well powered to address all aims.  
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, for Aim 2, assuming we have 124 participants 
completing 12-month outcome follow-up, we will have 90% power to detect a 81-minute difference in 
sitting time between I-STAND with boosters compared to I-STAND without boosters at 12 months. 
Further, given Scenario 2 in which I-STAND boosters is not different than I-STAND without boosters we 
will have 90% power to detect a 57-minute difference in sitting time with combined I-STAND groups. 
Given Scenario 1, in which I-STAND with boosters is significantly different from I-STAND without, at 12 
months, we will have 90% power to detect a 70-minute difference in sitting time between either I-
STAND group and the attention control. For blood pressure outcomes, we have 90% power to detect 
an 12.3 mmHg change in systolic blood pressure and 8.0 mmHg change in diastolic blood pressure 
when comparing I-STAND groups (booster vs. no booster) at 12 months.  We acknowledge we will 
likely be underpowered for Aim 2 and this is why we have now made it exploratory. 
 
 
 
b. Sharing of Results with Subjects 
Describe whether results (study results or individual subject results, such as results of standard 
or research lab tests and genetic tests) will be shared with subjects or their providers. 
 
 
If the study carries a risk of incidental findings, describe your plan for evaluating these and 
determining whether and how subjects or their providers will be given this information. 
 
 
 
If laboratory results will be shared with subjects or their healthcare providers, verify that the 
laboratory conducting the test is Clinical Laboratory Improvement Amendments (CLIA) certified. 
 
 
ORIGINAL (in-person) COHORT:  
Summary of overall study findings at completion of study will be shared with participants. During 
the course of the study, only the i-STAND group will receive feedback charts (showing their 

 
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activPAL data). Both groups may receive materials from the group they were not randomized to 
if they request. Neither group will receive printouts of their HbA1c (or blood glucose*) levels  as 
these are for data purposes only and are not clinically relevant.  As noted in the description of 
the visit procedures, if participants inquire about their blood values or blood pressure, we will 
share the information with them but without interpretation and advise them to see their provider 
if they have questions or concerns. If there are abnormal results, as stated in the consent form, 
“…if results are out of range, we will contact the study physician on call and confirm that there 
are no irregularities of concern. You may be advised to contact your primary care provider after 
the visit if there is a concern.” 
 
(*This applies to those who previously had blood glucose tested prior to removal of this as a 
measurement item in early 2020.) 
 
REMOTE (phone) COHORT:  
Summary of overall study findings at completion of study will be shared with participants. During 
the course of the study, only the i-STAND group will receive feedback charts (showing their 
activPAL data). Both groups may receive materials from the group they were not randomized to 
if they request. As noted in the description of the visit procedures, if participants inquire about 
their blood pressure, we will advise them to see their provider if they have questions or 
concerns. If there are abnormal results, as stated in the consent form, “…if results are out of 
range, we will contact the study physician on call and confirm that there are no irregularities of 
concern. You may be advised to contact your primary care provider after the visit if there is a 
concern.” 
 
c. Data and/or Specimen Banking 
Indicate if specimens may be used for future research and whether that may include genetic 
research.  
 
State if data or specimens will be sent to a separate repository. If data or specimens will be 
banked in a repository for future use as part of this protocol submission address the following 
questions: 
 
What will be banked and what identifiers will be associated with the data or specimens? 
 
Where and how will the data or specimens be stored? 
 
For what purpose will the data or specimens be used? 
 
How will the data or specimens be accessed, and who will have access? 
 
Describe the procedures to release data or specimens, including the process to request 
a release, approvals required for release, who can obtain data or specimens, and the 
data to be provided with specimens. 
Not applicable 
 
6. Privacy, Confidentiality and Data Security 
Describe the steps that will be taken to protect subjects’ privacy during recruitment, consent and 
study procedures. 
 
ORIGINAL (in-person) COHORT: 
 
Letters: Letters will be addressed only to participant with “confidential” marked clearly on 
envelope 

 
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 
Emails will be sent if requested by the participant for the purposes of scheduling a 
visit/coaching call or sending a reminder about a visit/coaching call. Any emails sent with 
program materials will include a reminder not to discuss personal information in a 
response. If a feedback chart is emailed by request to an i-STAND participant, it will be 
sent via encrypted email and participants will be given instructions (included in this IRB 
mod) on how to decrypt that email.  
 
Phone calls will only occur with those participants who have not opted out of being 
reached (per their letter, they will be provided with an opt-out number). If the participant 
is not home, staff member will call again when they can speak with participant. 
 
In-person written consent will take place in the privacy of a clinic room at the downtown 
Seattle Kaiser Research Institute  
 
All in-person sessions will be private (not group-based)  
 
Study participation will not be documented in EMR* 
 
File destruction will occur no later than 5 years from the end of the study or June 1, 
2028.  
 
* If a participant is found to have out-of-range blood pressure or blood draw readings during a 
measurement visit, the RS may contact the staff MD on call and/or the KP Consulting Nurse Service. In 
this event, the nurse service may make a note in the participant’s medical record of the out-of-range 
reading. If the MD on call determines the measurement is of particular concern, s/he may notify the 
participant’s provider as outlined on page 3 of the study DSMP.  
 
REMOTE (phone) COHORT:  
 
Letters: Letters will be addressed only to participant with “confidential” marked clearly on 
envelope 
 
Emails will be sent if requested by the participant for the purposes of scheduling a 
visit/coaching call or sending a reminder about a visit/coaching call. Any emails sent with 
program materials will include a reminder not to discuss personal information in a 
response. If a feedback chart is emailed by request to an i-STAND participant, it will be 
sent via encrypted email and participants will be given instructions (included in this IRB 
mod) on how to decrypt that email.  
 
Phone calls will only occur with those participants who have not opted out of being 
reached (per their letter, they will be provided with an opt-out number). If the participant 
is not home, staff member will call again when they can speak with participant. 
 
All phone sessions will be private (not group-based)  
 
Study participation will not be documented in EMR* 
 
File destruction will occur no later than 5 years from the end of the study or June 1, 
2028.  
 
If using e-consent: The completed PDFs are in the REDCap File Repository (located behind KP 
firewall) under “PDF Survey Archive.” Files can be downloaded as individual records or bundles 
in a ZIP file. Note: only users with ‘Full data set’ data export privileges will be able to download 
the archived files. The e-Consent Framework also records the IP address of the participant and 
displays this information in the file repository in order to help regulate potential duplicate forms 
from a single IP address. PDFs will be downloaded to the G drive so that we can retain copies 
per the study for up to 5 years. When the study ends, we will deleted the REDCap files. 
 

 
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* If a participant is found to have out-of-range blood pressure during a measurement visit, the RS may 
contact the staff MD on call and/or the KP Consulting Nurse Service. In this event, the nurse service 
may make a note in the participant’s medical record of the out-of-range reading. If the MD on call 
determines the measurement is of particular concern, s/he may notify the participant’s provider as 
outlined on page 3 of the study DSMP.  
 
 
a. Describe the plan for storage of data and/or specimens. 
 
Who will have access and how. 
 
Where the data/materials will be stored and for how long. 
 
What identifiers will be included. 
 
Any other steps that will be taken to ensure security (e.g., training of staff, authorization 
of access, password protection, encryption, physical security, and separation of 
identifiers from data and specimens, certificates of confidentiality). 
 
Describe the plan to deidentify data, destroy data, or retain/archive data at the end of the 
study. 
Data Security: Only study staff that need to know will be able to access identifiable information 
about the human subjects. This includes research support specialists working with subjects, 
project managers, Dr. Arterburn, Dr. Green and Dr. Rosenberg, and health coaches. All data 
containing identifying information will be kept on password-protected computers using 
password-protected files. Outcomes data will be stored in a separate file for data analysis and 
no personally identifiable information will be kept in that file; instead we will use unique study 
identifiers.  
In addition, we will collect adherence data (tracking completion of the in-person session and 
phone calls) for both intervention groups as well as additional inclinometer (activPAL) data from 
the i-STAND intervention group. We will audio-record phone sessions to be used in monitoring 
treatment fidelity.   
The likelihood of breach of confidentiality is minimal, as outcome-oriented study data are 
identified only by study ID and files are password protected. Hard copies, audio files, and 
tracking data are retained in secured locations accessible only to project staff with a specific 
need for access. All KPWHRI staff receive training in the protection of confidentiality of research 
participants. Participants will be informed of all anticipated risks in the informed consent and 
provided with verbal and written safety information. 
Multiple steps will be taken to protect participant confidentiality. Subjects' personal identities will 
not appear on any study data forms, and all forms and data files containing personal identifiers 
will be stored separately in secured files. All study files, including digital audio files of the 
intervention sessions, will be maintained in a centralized location on the KPWHRI departmental 
server. Access to the file is password protected and subject to the same security protections as 
other confidential health plan data. Access to the audio files will be limited to the study health 
coaches and Dr. Rosenberg who will review the tapes for treatment fidelity. Audio files will be 
deleted as soon as possible after they are coded for fidelity. All staff are trained in appropriate 

 
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security protections, computer passwords are changed on a regular basis, and all staff sign 
annual confidentiality agreements.   
 
i-STAND participants who use Fitness devices will not have those devices linked to a personal 
account. They will be solely linked to a study-account for the purpose of setting the 15-minute 
reminders to stand. No PHI will be linked to the device. 
 
 
 
b. Collection of data from subjects electronically 
If you will collect any data from participants electronically (including email, website, etc.), 
explain: 
 
How the data will be collected. 
 
How the information will be secured (encryption, password protection, etc.; may require 
consultation with IT department). 
 
Any risks to the participants’ privacy posed by using these methods (describe in consent, 
as applicable). 
 
How you will verify the participant’s identity. 
 
 
ORIGINAL (in person) COHORT:  
Data Collection:  
Electronic data collected as part of this study will include: 
1) Email addresses will be collected if a participant indicates that they wish to manage 
scheduling, consent or reminders for visits and calls via email. 
 
2) Self-reported survey results, documented in REDcap (input either directly by participants 
using a tablet or, if participant is not comfortable with the technology, they can provide the 
responses to the survey questions on paper and it will be entered by the research specialist; 
the paper copy will be destroyed. Note: we are using an internal version of the REDcap 
database that exists behind the KPWA firewall which also applies to those consents to be 
collected online. The completed signed (consent) PDFs are temporarily stored in the 
REDCap File Repository under “PDF Survey Archive.” Only study staff with full access to the 
REDCap account have access to these files. They will be downloaded to a G Drive folder so 
we can delete the entire REDCap project once the study is closed. As with other study files, 
these will be destroyed five years after the study ends as noted throughout this document 
 
3) Data provided by the inclinometer (activPAL) worn by participants at key timepoints. 
Data from the activPAL is collected by taking the small device, inserting a connecting cord from 
the device to a KPWHRI computer with activPAL software, downloading the participant’s activity 
record from the previous week and using that record to provide an visual of how much 

 
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sedentary time occurred. This will all be done by a research specialist who will receive training 
in using the activPAL software. The activPAL device and the software for analyzing results are 
both made by Glasgow, Scotland-based PAL Technologies Ltd.  
i-STAND group participants will be asked to wear activPAL activity monitors for five or six (if 
they get boosters) 1-week periods: baseline, one week after baseline, one week at 3 months 
post-randomization, one week at midpoint (6 months), one week at 9 months (those receiving 
boosters only) and at 12 months (follow-up).  Healthy living group participants will be asked to 
wear activPAL activity monitors for four 1-week periods: baseline, 3 months, 6 months, and 12 
months (follow-up).   
 
 
We will also give i-STAND participants the option of wearing activity wristbands and using a 
portable standing desk. The wristbands provide a mild vibration after 15 minutes of inactivity.  
Settings will be configured using a generic study team account with no identifiable patient data; 
participants will not create their own account and no personally identifiable information will be 
shared with the company making the activity bands, as all bands will be assigned a generic 
email unattached to a subject name or identification.  
 
Participants can stop wearing the activPAL and activity devices at any time. 
Once an activPAL device is returned by a participant, all data from the activPAL devices will be 
promptly downloaded directly onto KPW computers by a study RS. It will never be stored or 
shared outside the KP firewall. Data from the activity device will not be downloaded or stored for 
any reason. Upon return of the device, a study RS will wipe the device, resetting it for future 
use.  
COVID-19 UPDATE: Until normal business resumes, activPAL data will be downloaded onto 
study team member home computers (coaches and RS staff). All staff member personal  
computers are password protected.  In addition, the activPAL data is fully de-identified.  Once 
downloaded from the activPAL device, data will be immediately moved to the KPWHRI shared 
drive and deleted from personal computers.We have completed a Tech Risk Review which 
deemed this activity from home, using Secure File Transfer from a home computer to a 
KPWHRI shared drive is considered low risk.  
 
REMOTE (phone) COHORT:  
Data Collection:  
Electronic data collected as part of this study will include: 
4) Email addresses will be collected if a participant indicates that they wish to manage 
scheduling and reminders for visits and calls via email. 
 
5) Self-reported survey results, documented in REDcap (input either directly by participants 
using a tablet or, if participant is not comfortable with the technology, they can provide the 
responses to the survey questions on paper and it will be entered by the research specialist; 
the paper copy will be destroyed. Note: we are using an internal version of the REDcap 

 
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database that exists behind the KPWA firewall. 
 
6) Data provided by the inclinometer (activPAL) worn by participants at key timepoints. 
Data from the activPAL is collected by taking the small device, inserting a connecting cord from 
the device to a KPWHRI computer with activPAL software, downloading the participant’s activity 
record from the previous week and using that record to provide an visual of how much 
sedentary time occurred. This will all be done by a research specialist who will receive training 
in using the activPAL software. The activPAL device and the software for analyzing results are 
both made by Glasgow, Scotland-based PAL Technologies Ltd.  
i-STAND group participants will be asked to wear activPAL activity monitors for five or six (if 
they get boosters) 1-week periods: baseline, an optional one week wear 6 weeks after baseline, 
one week at 3 months post-randomization, one week at midpoint (6 months), another optional 
one week wear at 9 months (those receiving boosters only) and at 12 months (follow-up).  
Healthy living group participants will be asked to wear activPAL activity monitors for four 1-week 
periods: baseline, 3 months, 6 months, and 12 months (follow-up).   
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, neither the i-STAND cohort nor the 
control cohort will have a 12-month assessment. Furthermore, the i-STAND cohort will 
not be offered the optional wears (6-week and again at 9-months if they were to be re-
randomized).  
 
 
 
We will also give i-STAND participants the option of wearing activity wristbands and using a 
portable standing desk. The wristbands provide a mild vibration after 15 minutes of inactivity.  
Settings will be configured using a generic study team account with no identifiable patient data; 
participants will not create their own account and no personally identifiable information will be 
shared with the company making the activity bands, as all bands will be assigned a generic 
email unattached to a subject name or identification.  
 
Participants can stop wearing the activPAL and activity devices at any time. 
Once an activPAL device is returned by a participant, all data from the activPAL devices will be 
promptly downloaded directly onto KPW computers by a study RS. It will never be stored or 
shared outside the KP firewall. Data from the activity device will not be downloaded or stored for 
any reason. Upon return of the device, a study RS will wipe the device, resetting it for future 
use.  
COVID-19 UPDATE: Until normal business resumes, activPAL data will be downloaded onto 
study team member home computers (coaches and RS staff). All staff member personal  
computers are password protected.  In addition, the activPAL data is fully de-identified.  Once 
downloaded from the activPAL device, data will be immediately moved to the KPWHRI shared 
drive and deleted from personal computers.We have completed a Tech Risk Review which 

 
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deemed this activity from home, using Secure File Transfer from a home computer to a 
KPWHRI shared drive is considered low risk.  
 
 
c. Does this study involve the disclosure of PHI to a collaborator? 
If any data will be sent outside of this site, list each recipient (may list by role or category if the 
information is the same for several different entities).  For each recipient, describe: 
 
What will be sent. 
 
Whether the information will be fully identifiable (PHI, if health information), a Limited 
Data Set, de-identified, or aggregate. 
 
How the data/materials will be transferred securely (for instance, Secure File Transfer). 
Not applicable 
 
7. Provisions to Monitor Data to Ensure the Safety of Subjects 
This is required when research involves more than Minimal Risk to subjects. 
 
The plan might include establishing a data monitoring committee and a plan for reporting data 
monitoring committee findings to the IRB and the sponsor. 
Describe: 
 
Who will monitor the study data for safety? 
 
The plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe. 
 
What data are reviewed, including safety data, untoward events, and efficacy data. 
 
How the safety information will be collected (e.g., with case report forms, at study visits, 
by telephone calls with participants). 
 
The frequency of data collection, including when safety data collection starts. 
 
The frequency or periodicity of review of cumulative data. 
 
Criteria for taking action on monitoring findings (for instance, stopping rules, immediate 
suspension, reporting, protocol changes, changes to monitoring frequency or plan). 
 
For studies monitored by a DSMB/C, describe the committee membership and structure, 
meeting format, and quorum requirements.  Upload the board/committee charter, if one 
exists. (This bullet is not applicable) 
Dr. Rosenberg, the PI, will be responsible for notifying the IRB of all adverse events (AEs).  All 
participants learned to be deceased during the course of the study, regardless of the cause of 
death, will be reported to the IRB.  The IRB will work with the PI to ensure additional agencies 
(e.g., NIH) are notified as required.  The IRB will also determine if other immediate action is 
required (e.g., suspension of recruitment, protocol closure, etc.).  Temporary or permanent 
suspension of an NIH-funded protocol will be reported to the NIH grant program director directly 
responsible for the grant. 
 
Monitoring of Adverse Events by PI and Project Staff.  Project staff (health coaches, research 
specialists, programmer, etc.) will be trained to identify potential AEs, document events on an 
adverse event form, and report any events immediately to the study PI and the project manager.  
Dr. Rosenberg will ensure that all AEs are appropriately handled and reported to the IRB and 
NIH authorities, as appropriate.  The project manager will conduct routine protocol compliance 

 
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checks to ensure that safety procedures, such as ensuring participant confidentiality and 
maintaining approved standards for data transport, are strictly adhered to. In the case that the 
MD on call for the team (either Dr. Arterburn or Dr. Green) and /or the DSM Dr. James Ralston, 
determines that a participants lab values are out of range to an extent that they believe the 
participants provider should be notified, s/he may contact the provider (see the DSMP protocol) 
explaining the results of the test (example: high blood pressure). In order to do this, we need to 
collect the participant’s provider name and have added this to the Contact Sheet.  
 
Note: The study physician may determine what method of contacting the provider is most 
appropriate given the needs of the individual participant. 
For the purposes of any Epic messages, only Drs Green and Nelson have Epic access and the 
only ones who would use this means of contacting a participant’s provider.  
 
HIPAA Compliance.  All participants will be recruited from KPWA.  As such, their participation is 
subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and 
security standards.  All KPWHRI staff have completed required HIPAA training, and all research 
activities will be conducted in compliance with the HIPAA standards.   
 
Monitoring Data Quality and Integrity.  Several procedures will be used to maintain data 
integrity.  All databases will be stored in a centralized location on a departmental server at 
KPWHRI.  Data will be backed up daily, and access to any participant information will be 
password protected and limited to persons working on the project.  Project staff will only have 
access to specific data required for their project tasks.  Identifying information will be stored 
separately from the assessment data.  Data will be audited on an ongoing basis by the Project 
Manager to ensure confidentiality safeguards are being upheld and data integrity is being 
maintained.  Data entry systems will be set up to allow field checks, range checks for 
continuous variables, valid value checks for categorical variables, and checks for logical 
consistency of responses.  Queries and data reports will be generated on a routine basis to 
monitor data quality. REDCap data integrity safeguard: we are using the internal version of 
REDcap which is behind the KPWA firewall. 
 
Data Safety Monitoring Panel.  Dr. Rosenberg will monitor the study in compliance with IRB-
approved procedures.  A Data Safety Monitoring Panel, composed of two KPWHRI investigators 
who are not associated with the project, will review all adverse events and make final 
determinations as to whether any AEs are study related. On a quarterly basis during the course 
of the trial, the panel will evaluate the adverse event data to protect the safety of the study 
participants.  It will make specific recommendations to the PI and study team regarding 
modifications to the intervention based on any observed adverse effects of the treatment under 
study. 
 
8. Risks and Benefits  

 
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a. Risks to Subjects 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects 
related the subjects’ participation in the research. Describe the probability, magnitude, duration, 
and reversibility of the risks. Consider physical, psychological, social, legal, and economic risks. 
 
If applicable, indicate which procedures may have risks to the subjects that are currently 
unforeseeable. 
 
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant. 
 
If applicable, describe risks to others who are not subjects and risks to Kaiser 
Permanente 
The primary risks of participation include a breach of confidentiality; emotional upset or 
embarrassment due to participation in the research intervention, in-person measurements, and 
surveys; and potential adverse events related to participation in the intervention. People may 
feel uncomfortable wearing small devices that capture movement. The waterproof medical 
dressing used to secure the activPAL to the top of the thigh could result in skin irritation, though 
this outcome has rarely been reported in previous studies using activPAL and we use a medical 
grade adhesive. However, if this occurs, participants can discontinue use, try their other leg, or 
try a different adhesion method. Participants may feel uncomfortable when having their height 
and weight measured, performing brief physical function tasks, or completing a survey which 
asks about psychosocial factors, well-being, and quality of life. Persons who choose to increase 
their routine physical activity levels could experience physical-activity-related injuries such as 
pulled muscles or sprains. Participants may experience discomfort and/or local bruising at the 
site of the capillary finger stick blood draw.   
 
For those participants with high or low blood pressure, the potential improvement in physical 
health is greater than potential adverse effects from increasing standing time. The goal of the i-
STAND intervention is to increase breaks from sitting time.  Study physicians do not think these, 
or any participants, are likely to experience harms greater than those encountered in normal life 
because standing up is a typical daily activity. Any unanticipated events that do occur will be 
documented in the AE form. At best, participants may be at increased risk for muscle 
stiffness/soreness or falls from standing/moving more, but longer term their physical health may 
benefit from reduced sedentary time.   
 
In the event that a participant presents with any of these symptoms while waiting to be seen for 
their in-person measurement visit (e.g.: in the waiting room), the RS will follow the “Physical 
Health Concern Protocol” which entails contacting the KP Consulting Nurse Service, and follow 
directions from that nurse, and possibly rescheduling the measurement visit for another time. 
 
The likelihood of breach of confidentiality is minimal, as outcome-oriented study data are 
identified only by study ID and files are password protected. Hard copies, audio files, and 
tracking data are retained in secured locations accessible only to project staff with a specific 
need for access. All KPWHRI staff receive training in the protection of confidentiality of research 
participants. Participants will be informed of all anticipated risks in the informed consent and 
provided with verbal and written safety information.  Per the consent, if a participants lab values 
are out of range to an extent that the MD on call (Dr. Green or Dr. Arterburn) believes the 
participants provider should be notified, s/he will send a letter (included in the DSMP protocol) to 
the provider explaining the results of the test (example: high blood pressure).  

 
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b. Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the 
research. Include as may be useful for the IRB’s consideration, the probability, magnitude, and 
duration of the potential benefits. Indicate if there is no direct benefit. You may include benefits 
to society or others. 
All participants who consent to participate may receive some satisfaction or indirect benefit from 
contributing to this research. Additional benefits include advice and guidance on ways to reduce 
sedentary behavior and improve health. People who make lifestyle changes may experience 
other positive gains such as weight loss, reduced disease risk, improved mental health, and 
better management of existing chronic conditions.   It is possible they may not experience any 
benefit at all.       
 
9. Economic Burden to Subjects  
Describe any costs that subjects may be responsible for because of participation in the research 
study (for example, co-pays; paying for treatment, therapies, or other interventions, or the 
delivery of these) and how you will inform participants of these costs prior to their enrollment in 
this study. 
Not applicable. Participants will have parking validated and/or bus/light-rail tokens provided.  
 
10. Compensation to Participants  
Describe any compensation provided to participants, for example, for time inconvenience, 
discomfort, travel, or in the event of research related injury. If applicable, describe how you will 
inform participants of this prior to their enrollment in the study, including if payment will be 
prorated if the subject withdraws early from the study.  
 
NOTE: payment may not be withheld as an incentive for participants to complete the study. 
Participants will receive $30 incentives for completing measurements after each of the 4 
measurement visits and a $30 bonus for completing all visits ($150 total). Finally, 
participants in both intervention arms will be offered the written materials for the 
intervention they did not receive at the end of the study. i-STAND participants will be 
asked to return both the wrist-worn activity band and the standing desk. 
 
 
2022 BUDGET CUT UPDATE: As of March 31, 2022, there will no longer be a 12-
month visit, bringing the new total amount given to participants to $120. We will 
continue to give a $30 bonus for completing the other timepoints (Baseline, 3 and 
6 months).  
 
 
 
11. Resources Available 
Describe any special resources or expertise required to conduct the study. 
Not applicable 
 

 
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12. Prior Approvals 
Describe any approvals that will be obtained prior to commencing the research. (e.g., school, 
external site. funding agency, laboratory, radiation safety, or biosafety approval.)  
Not applicable. 
 
13. Drugs or Devices 
NOTE: see the ICH-GCP guidance for a summary of investigator and sponsor responsibilities in 
clinical trials. 
 
a. Drug Studies 
If the research involves drugs and is investigator-initiated, indicate whether there is any 
possibility that the results will be reported to FDA (e.g. as part of a new drug application [NDA]). 
 
 
If the drug is investigational (has an IND), confirm that you will comply with all applicable 
FDA requirements for investigators.   
 
Confirm that you will follow applicable KP pharmacy policies and procedures. 
 
Describe your plan for drug storage, handling, and accountability, including distribution, 
return, and destruction of the drug(s). 
Not applicable 
 
 
b. Device Studies: 
If this is a device study and you think the device is Non-Significant Risk, include justification 
here or upload it as a separate document along with any available device information 
(instructions for use, etc.). 
 
If the research involves devices and is investigator-initiated, indicate whether there is any 
possibility that the results will be reported to FDA (e.g. as part of a premarket approval 
application [PMA]). 
 
 
If the device has an IDE or a claim of abbreviated IDE (Non-Significant Risk device), 
confirm that you will comply with all applicable FDA requirements for investigators.   
 
Describe the device, the manufacturing process, and the device labeling, including 
safety instructions or warnings.  If available, this may be addressed in separately 
uploaded device information (such as instructions for use). 
 
Describe device storage, handling, and accountability, including how access to the 
device will be limited to appropriate personnel and how you will ensure the device will be 
used only for appropriate study subjects.  
Not applicable 
 
14. Multi-Site Research  
a. If this is a multi-site study and you are the lead investigator or this site will be the 
coordinating center for any activity, describe the processes to ensure communication 
among sites, such as: 
 
All sites have the most current version of the protocol, consent document, 
and HIPAA authorization. 

 
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 
All required approvals have been obtained at each site (including approval by 
the site’s IRB of record). 
 
All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
 
All engaged participating sites will safeguard data as required by local 
information security policies. 
 
All local site investigators conduct the study appropriately. 
b. Describe the method for communicating to engaged participating sites the following:  
 
Problems. 
 
Interim results. 
 
The closure of a study. 
 
c. Describe any special resources or expertise required to conduct the study. 
Not applicable 
 
 
 
15. Community-Based Participatory Research  
Describe involvement of the community in the design and conduct of the research. 
 
Describe your plan for ensuring that community research partners are appropriately trained in 
human subjects’ protection.  
 
NOTE: “Community-based Participatory Research” is a collaborative approach to research that 
equitably involves all partners in the research process and recognizes the unique strengths that 
each brings. Community-based Participatory Research begins with a research topic of 
importance to the community, has the aim of combining knowledge with action and achieving 
social change to improve health outcomes and eliminate health disparities. 
Not applicable 
  
 
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