Take Active Breaks From Sitting (TABS): Reducing Sedentary Time in Older Adults
Phase: NA
Conditions: Obesity, Sedentary Lifestyle
Sponsor: Kaiser Permanente

 
 
Clinical Protocol 
I-STAND R21: Reducing Sedentary Time in Older Adults 
NCT02692560 
2/12/2018 
 
 
Excerpted from: 
Rosenberg DE, Lee AK, Anderson M, Renz A, Matson TE Kerr J, Arterburn D, McClure 
JB.  Reducing Sedentary Time for Obese Older Adults: Protocol for a Randomized 
Controlled Trial.  JMIR Res Protoc 2018 (Feb 12); 7(2):e23.e 
 
Methods 
Trial Design  
A 12-week single-blind, randomized two-arm trial design was employed to evaluate the 
efficacy of the I-STAND intervention for decreasing sitting time compared to a healthy 
living control group. Enrollment began in February 2016 and data collection finished in 
February 2017. 
Setting 
The study is being conducted by the Kaiser Permanente Washington Health Research 
Institute (formerly, Group Health Research Institute). All activities were reviewed and 
approved by the Kaiser Permanente Washington (KPWA) Institutional Review Board.  
Recruitment 
Potential participants were identified using electronic health records from members of 
Kaiser Permanente Washington. Participants were limited to members whose primary 
care clinics were located in King County, WA to facilitate in-person appointments. 
Individuals were deemed potentially eligible if their: electronic medical records indicated 
they were aged 60-89, body mass index was ≥ 30 (to select for a group at risk for 
chronic conditions who may benefit the most from sedentary time reduction), and 
enrollment in the health plan was continuous for the prior 12 months. Individuals were 
excluded if they resided in long-term care or a skilled nursing facility in the prior 12 
months, had a new cancer or heart failure diagnosis, or had a new diagnosis of 
dementia or serious mental health disorder.  
 
Study invitation letters were mailed to a random selection of potentially eligible 
individuals who met the criteria above. Those who were interested in learning more were 
asked to call study staff for more information. Up to three mailings were sent to potential 
participants if they did not respond to the initial invitation or opt out of further contact. 
Interested responders were screened for eligibility by phone. Additional eligibility 
requirements were: self-report of sitting ≥ 7 hours per day, able to stand, and able to 
walk one block with or without an assistive device. 
Contacts and Procedures 
Persons screened as potentially eligible by phone provided oral consent to participate 
and were scheduled for an in-person appointment. They were then mailed an activPAL 
device to wear on the front middle part of the thigh with a waterproof dressing. 
Participants were provided with clear instructions and photos showing them how to 
adhere the device to their leg. The device was worn on the leg 24 hours a day to assess 

active and sitting time; participants wore the device for at least 7 days prior to coming to 
an in-person baseline assessment.  Participants completed a log to record their sleeping 
hours.  
 
At the in-person baseline visit, participants met with a study staff member who collected 
written informed consent, downloaded their activPAL data, and collected other baseline 
assessment data (including a questionnaire, biometric assessments, and a fasting blood 
draw). A separate study health coach then randomized individuals and met with them to 
inform participants of their randomization group. Participants then completed their first 
health coach visit in person. Participants randomized to the I-STAND intervention arm 
were also provided a Jawbone UP band and trained on how to use it. The baseline visit 
lasted 1.5-2 hours.   
 
Participants also completed an in-person assessment at 3 months post-randomization. 
Similar to baseline, each person wore an activPAL device for 7 days prior to the visit to 
assess active and sedentary behavior. During the 3-month visit, the biometric 
assessments and blood draw were repeated by a blinded study staff member, and a 
follow-up questionnaire was also administered. Participants received $50 each for 
completing the baseline and 3-month visit. A subsample of I-STAND participants (n = 22) 
were invited to participate in a separate qualitative exit-interview following study 
completion. Interviews were conducted by phone within 10 days of the final session. 
Additional study contacts are outlined as part of the descriptions of the intervention and 
control conditions (below). 
Randomization & Blinding 
Randomization occurred during the in-person baseline visit. The health coach used an 
automated macro, developed and overseen by the study statistician in Stata, to process 
the participant’s downloaded baseline activPAL data. The macro computed preliminary 
estimates of activity metrics such as average daily sitting and standing time. Participants 
were randomized in a 1:1 allocation to I-STAND or the healthy living control. 
Randomization was stratified by baseline average daily sitting time (≥9 hours vs. <9 
hours), in permuted blocks of randomly varying size (2 or 4). Staff responsible for 
collecting baseline and follow-up data were blinded to participants’ treatment arm. 
Participants and health coaches were aware of treatment assignment, since individuals 
received a different intervention depending on their assignment. 
I-STAND Intervention 
Theoretical framework. The experimental I-STAND intervention was based on relevant 
behavioral theories including social cognitive theory, the ecological model, and habit 
formation. Social cognitive theory posits that the interaction of individual, social, and 
environmental influences impact behavior. Specifically, constructs such as self-efficacy, 
social support, goal-setting and action planning, and cues were deemed important for 
inducing changes in sitting behavior. The ecological model specifies the importance of 
considering influences at the built environment level including the home and 
neighborhood environment which could shape sitting behaviors (Sallis, 2008). Principles 
of habit formation suggest that unconscious and automatic processes typically underlie 
decisions to sit. Bringing these decisions into conscious awareness will help make 
decisions to stand (instead of sit) more automatic over time (Lally, 2011). 
 
Intervention Development.  In our prior work we developed a theory-based ST reduction 
intervention (using the theories above) and tested it over 8 weeks among older adults 

with obesity (Rosenberg et al., 2015). We then conducted in-depth qualitative interviews 
to refine and improve the program (Greenwood-Hickman et al., 2016). The program 
resulted in a 30-minute reduction in sitting time, comparable to other preliminary studies 
in older adult populations. The interviews suggested that sitting is a highly ingrained 
habit often performed unconsciously and additional prompts were suggested to help 
constantly remind participants to bring their sitting habits into conscious awareness. 
These findings further informed the design of the I-STAND intervention.  
 
Format. I-STAND consisted of 2 in-person health coaching sessions (the first 
immediately following their baseline measurement visit and the second 1 week later), 4 
follow-up health coaching phone calls (every 2 weeks after the first 2 in-person 
sessions), and written materials. Participants were also offered email reminders to work 
on their individual goals on the off-weeks of the biweekly calls.   
 
Key Components. I-STAND combined the behavioral theories into an approach that 
focused on using inner, outward, and habit reminder strategies to enhance awareness of 
sitting behavior and enabled participants to make simple changes that would enhance 
self-efficacy and reduce sitting time (see Table 1). One of the main tools provided to 
participants was a Jawbone UP band (Jawbone®, San Francisco, CA) to provide gentle 
vibrations every 15 minutes of inactivity to remind participants to take breaks from sitting 
regularly throughout the day (serving as an outward reminder) (Rosenberg, 2017). In 
addition to reminder strategies, key components included: 1) a workbook with biweekly 
content focusing on the various types of reminder strategies, which was used with each 
health coaching session; 2) feedback charts were provided to participants based on their 
activPAL wear at baseline and wearing the device at 2 additional check-in points 1 week 
following the baseline week and at the study mid-point (~week 6). The feedback charts 
included both numeric and graphic depictions of average daily waking time spent sitting, 
standing, and stepping, as well as their total breaks from sitting, sitting bouts lasting 
longer than 30 minutes, and step count; and, 3) health coaching sessions as described 
below. Table 1 provides an overview and descriptions of the I-STAND intervention 
components. 
 
Health coaching sessions. Sessions focused on using different types of reminders, 
building self-efficacy through motivational interviewing strategies, problem-solving 
barriers, and setting an action plan consisting of graded individualized goals using the 
workbook which contained action planning and goal-tracking worksheets. At the first in-
person intervention visit, health coaches met with participants for 1 hour to develop 
rapport, learn more about their daily activities, elicit motivations for joining the study, 
provide an intervention overview, and introduce and review study tools, including the 
workbook, feedback chart, and Jawbone UP wristband. They also reviewed safety 
information to ensure that participants would not injure themselves by standing more 
(e.g. stand on a cushioned surface, gradually build the amount of standing time).  Health 
coaches then worked with the participants to set an action plan with obtainable goals, 
using tailored reminder strategies. During the week following the baseline week, 
participants wore another activPAL monitoring device and returned in person to meet 
with the health coach. The second in-person visit, which lasted about 45 minutes, 
focused on reviewing participant progress on their goals and problem-solving barriers 
with the assistance of a second feedback chart from wearing the activPAL the prior 
week; learning about additional reminder strategies; and setting goals for the next 2 
weeks. Thereafter, health coaches met with participants by phone every 2 weeks (for 
approximately 20-40 minutes for each session) to review progress on goals, problem-

solve barriers, use the workbook to guide participants on different types of reminders, 
and set new action plans at the end of the visit. Additional topics covered in the 
workbook and health coaching sessions included social support, social environment and 
norms, conducting a home environment audit, and making home and/or work 
environment changes based on the audit results. 
  
Table 1. Overview of I-STAND Intervention Components 
Component 
description 
Examples of content 
Health coaching 
sessions:   
2 in-person and 4 
phone calls 
• 
Motivational interviewing to identify values and support 
goal attainment 
• 
Learning about reminder strategies and selecting 
personalized reminders to help achieve goals 
• 
Enhancing self-efficacy for sitting reduction  
• 
Problem-solving identified barriers to achieving goals 
• 
Reviewing feedback charts at in-person sessions and at 
mid-point 
• 
Action planning including setting stepped goals building 
towards a 1-hour reduction in sitting time 
Feedback charts: 
Provided 3 times 
during the 
intervention  
• 
Color graphs and tables showing sitting time, standing 
time, breaks from sitting, steps, number of sitting bouts 
lasting longer than 30 minutes  
• 
Reviewed during health coach sessions at baseline, 1 
week, and 6 weeks 
Workbook: 
Provided at first in-
person session 
• 
Written educational materials 
• 
Action-planning pages 
• 
Goal-tracking forms   
• 
Home environment audit form 
Reminder 
strategies 
Inner: Internal or 
bodily cues  
• 
Using mindfulness to be more aware of how body feels 
when sitting 
• 
Standing up anytime you notice your body feeling 
uncomfortable 
Outward: Cues in 
the environment  
• 
Using the Jawbone UP band, a kitchen timer, or another 
identified environmental cue 
• 
Making environmental changes to the home based on 
audit results (e.g. setting up a standing work space, finding 
a counter on which to read the newspaper, moving 
furniture to create room to stand) 
Habit: Ingrained 
daily habits that can 
be used as cues  
• 
Standing for 5 minutes while engaging in daily habits such 
as drinking coffee, reading the newspaper, talking on the 
phone 
• 
Standing for 5 minutes after doing a daily habit like taking 
medication or going to the bathroom 
 
Healthy Living Control Condition 
 
Participants in the control condition received 1 in-person health coaching session (after 
the baseline measurements were completed) followed by 5 mailed contacts. The 
program was based on usual care that is available to members of KPWA. At the in-

person session, participants were provided with a workbook consisting of health 
education on a variety of topics relevant to aging including depression, advance 
directives, nutrition, sleep, pain, and bladder control. Participants were instructed to 
select 1 topic to work on every 2 weeks. Content was derived from online educational 
information available to KPWA members, which was approved by Kaiser Permanente 
physicians. During the in-person health coaching session, participants then worked 
through a goal-setting worksheet with the health coach to help get them oriented to their 
program. Every 2 weeks, participants received a check-in letter and were asked to 
complete a form to mail back regarding their progress with their goals.   
Health Coach Training and Fidelity 
The I-STAND and Healthy Living conditions were delivered by 2 health coaches who 
had relevant degrees but no prior experience with health coaching. They were trained by 
the study principal investigator who is a licensed clinical psychologist to use motivational 
interviewing strategies (e.g. reflective listening, open-ended questions, affirmations, and 
summaries) and problem-solving techniques to support behavior change. Fidelity was 
enhanced by using structured scripts for each session and materials in a study workbook 
specific to the intervention and control group. Initial sessions were audio-recorded and 
reviewed to support health coach training. All intervention contacts were tracked in a 
Microsoft Access tracking database.   
Assessment Measures  
The primary outcome was total daily waking hours spent sitting measured by the 
activPAL micro device (PAL Technologies Ltd, Glasgow, UK). The activPAL was used 
because it has been feasible in other studies with older adults (Rosenberg et al., 2015; 
Lewis et al., 2016; Grant et al., 2008), is sensitive to change, (Rosenberg et al., 2015; 
Kozey-Keadle et al., 2012) and has high validity in comparison to direct observations 
(Kozey-Keadle et al., 2011; Larkin et al., 2015; Lyden et al., 2012). The device was 
initialized, sealed in a waterproof casing and then adhered to the front center thigh with a 
waterproof medical adhesive (TegadermTM). Participants were instructed not to remove 
the device but they were given additional materials for affixing the device in the event 
that the adhesive became compromised or if they developed any irritation. They were 
provided with logs to track their sleep time each day they wore the device.  The data 
were downloaded and processed using proprietary activPAL software and programs 
developed for Stata and R statistical software packages. The processing programs 
removed logged sleep time from the data to calculate waking hours spent sitting. Similar 
to standard procedures for accelerometer processing, data were considered valid if wear 
time was greater than 10 hours per day with a minimum of 4 valid days of data for each 
assessment period (Troiano et al., 2008; Matthews et al., 2012; Ward et al., 2005). To 
account for variations in wear time, activPAL outcomes will be adjusted for wear time. In 
addition to sitting time, activPAL will be used to assess secondary outcomes including 
average daily sit-to-stand transitions, standing time, steps, and bouts of sitting longer 
than 30 minutes. 
 
Other secondary outcomes included physiologic measures and a battery of physical 
measures thought to be sensitive to changes in sedentary time and relevant for chronic 
disease. Physical function was measured by the Short Physical Performance Battery 
(SBBP). The SPPB objectively evaluated lower extremity function with tasks for balance, 
gait speed, and lower-extremity strength (chair rise) (Guralnik, 1995; Gurnalik, 1994). 
Cardiometabolic outcomes (fasting glucose and a cholesterol panel) were assessed by 
finger prick using an Alere Cholestech LDX System machine and Lipid + Glucose 

cassettes. This device has shown very good agreement with established laboratory 
methods (Donato, 2015; Carey, 2006; Shepard, 2007). Blood pressure was measured 
on the left arm using an Omron HEM-907XL digital monitor. Blood pressure was 
assessed 3 times and the average of the latter 2 measures used.  . 
Exploratory outcomes included cognitive function as measured by the Trail 
Making Test (TMT) Parts A and B (to assess psychomotor speed and fluid cognitive 
abilities) (Salthouse, 2011; Lezak, 2004). Time to complete each task as a raw score will 
be used in analyses.  weight which was measured with a calibrated portable digital scale 
(Tanita HD-351) and height with a stadiometer (Seca 213). Waist circumference was 
measured twice at the superior border of the iliac crest. The average of 2 measurements 
will be used in our analyses (Valsamakis, 2004). Additional exploratory outcomes were 
self-reported and included benefits and barriers of sitting reduction (Gardiner, 2011), 
self-efficacy for reducing sitting time (Gardiner, 2011; Salmon et al., 2006; Norman et al., 
2005; Norman et al., 2004), habit formation (Self-Report Habit Index) (Verplanken et al., 
2003), quality of life with the PROMIS global scale (Hays et al., 2009), and depressive 
symptoms with the Patient Health Questionnaire-8 (Kroenke et al., 2010; Kroenke et al., 
2009).  
Qualitative Assessment 
Qualitative exit-interviews lasted about 45 minutes and followed a semi-structured 
interview guide. The semi-structured interview guide was intended to capture feedback 
on the acceptability of the intervention, barriers and facilitators to sitting reduction, and 
perceived health impacts of sitting reduction.  Only I-STAND participants were 
interviewed. Due to scheduling and other logistics, 22 of the 29 intervention participants 
were interviewed. The interviews were audio-recorded and transcribed. A formal 
qualitative analysis using thematic analysis and a group of coders will be undertaken to 
identify barriers and facilitators to sitting reduction and guide future refinements to the I-
STAND intervention. 
Conflicts of Interest 
None declared. This study was funded by the National Institutes of Health (R21 
AG043853; Rosenberg, PI).  
Abbreviations 
RCT: randomized controlled trial 
ST: Sedentary time 
MVPA: moderate-to-vigorous physical activity 
 
 

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