Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Phase: NA
Conditions: Motor Activity, Health Behavior, Diabetes Mellitus, Type 2
Sponsor: University of Colorado, Denver

1 
11. SPECIFIC AIMS
The 
cardiovascular (CV) consequences of the 
growing T2D epidemic pose a major social and economic burden to society. Increasing physical activity is 
associated with reduced CV morbidity and mortality in people with T2D.   Physical activity levels are typically 
very low in people with T2D compared to similarly overweight nondiabetic people.1  Thus, increasing physical 
activity in people with T2D remains a critical CV health priority.  In prior RCTs of behavioral interventions in 
people with T2D,2 physical activity levels increased in response to behavior change tools such as goal setting 
and motivational interviewing to overcome participant barriers.  Integrating effective behavior change tools into 
clinical practice would provide a favorably broad reach.  However, prior behavioral interventions were time and 
resource-intensive and such interventions may not be practical in clinical practice settings.2  To move 
towards integrating physical activity interventions into clinical practice, we need behavioral interventions that 
are simple yet effective.3,4   
We have pilot data to suggest that trained clinical staff can successfully deliver a behavioral physical 
activity intervention.  Also, our clinic and others5 have implemented valid methods that can identify sedentary 
patients who could benefit from treatment.  In this grant application, we propose an innovative approach that 
fully integrates both trial recruitment standards (i.e., assessing participant inclusion/exclusion criteria) and 
intervention delivery methods into clinical practice settings. The chief advantages of the proposed work are: 1) 
using clinical staff and clinical processes to include appropriate patients who may be safely active — true 
clinical integration; 2) adding reimbursable in-person treatment visits with a physician assistant who 
coordinates treatment with clinic health promotion counselors — enhances safety and improves translational 
potential. 
My K23 research objective is to pilot-test the feasibility and effectiveness of an evidence-based physical 
activity counseling intervention that is tailored to patient barriers and facilitators.  My rationale is that the 
proposed research could shift the paradigm of physical activity counseling in primary care by developing an 
intervention that utilizes evidence-based behavior change methods but is brief enough to be widely 
implemented in clinical practice.  We are powered to detect differences in physical activity and we also expect 
improvement in our secondary outcomes related to physical activity and physical function.  
My focus previously was on lab-based supervised exercise to increase physical activity in adults with 
T2D and normal physical function — this has evolved to focus on translational research in primary care to 
increase physical activity in adults with T2D who often have physical function limitations. Therefore, my K23 
training goals are to acquire advanced skills in: 1) functional assessments and rehabilitation of adults with 
functional limitations and 2) implementation science methods.  Meeting my K23 goals for training and research 
will position me to lead the way to develop, test and implement clinical treatments to improve health and 
function for adults with T2D who are at high risk of cardiovascular disease.   
Purpose: Conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based 
physical activity program intervention vs. usual care in sedentary adults with T2D (n=130) in 2 primary care 
clinic sites to test two aims.  
Aim 1: Determine the effectiveness of a 12 week evidence-based physical activity program delivered by 
designated clinical staff and physician assistants, as compared to usual care, on: 
1a) physical activity by accelerometer (primary outcome) and physical activity predictor outcomes from the 
social cognitive theory (SCT) of behavior – e.g., self-efficacy, social-environmental support  
1b) physical function by physical performance measures (secondary outcome) and the physical function 
predictor of lower extremity strength  
Hypothesis 1:  Objective physical activity and physical function will increase more in the intervention vs. usual 
care study group. 
Aim 2: Assess process measures among patients, clinical staff, clinical providers, and practice leadership to 
determine acceptability and time burden. 
Hypothesis 2a: Over 80% of intervention patients would recommend the intervention to a friend. 
Hypothesis 2b: Over 80% of clinical staff/providers would recommend continuing to offer the intervention. 
CTRC Review Complete 
5/14/2015 
M. Crow Adams 
15-1080, PI: Amy Huebschmann, MD
COMIRB
APPROVED
19-Jun-2015

2 
 
Impact:  By determining the effectiveness of this program and by filling my training gaps, this K23 proposal has 
great translational potential to improve the health of adults with T2D. It also prepares me to be a national 
leader in the implementation of evidence-based physical activity programs at other clinical sites.  
 
 
12. RESEARCH STRATEGY 
12.1 SIGNIFICANCE 
12.1.1. Ongoing Importance of physical activity for CV disease prevention in T2D   The prevalence of 
diabetes mellitus has more than tripled in the past 30 years, and currently affects 25.8 million Americans.6  
T2D accounts for >90% of prevalent diabetes cases in adults.7  Because people with T2D are at very high risk 
for CV disease, people with T2D are a high priority NHLBI study population.8-11   Several large observational 
studies support regular physical activity as a potent therapy to reduce CV mortality in people with T2D.12-15 A 
recent meta-analysis of prospective cohort studies found improved CV outcomes in participants with diabetes 
by physical activity strata (HR = 0.61 (0.47-0.80) for CV mortality for highest vs. lowest physical activity 
levels).16  Data from RCTs have been mixed, as lower stroke event rates (HR = 0.62 (0.35-0.98) were 
observed in the intervention vs. placebo group of an RCT of a behavioral intervention that increased physical 
activity17, but the Look AHEAD study was stopped for lack of group differences in CV outcomes18.  Lower than 
expected CV outcomes in both Look AHEAD 
study groups may have under-powered this 
study to detect an intervention effect.18  
Overall, the consistent benefits of regular 
physical activity with regard to 
cardiorespiratory fitness, CV mortality, and all-
cause mortality that have been observed in 
large cohort studies provide a convincing 
evidence base that regular physical activity 
improves CV health.   Also, one study found 
mean annual health costs were ~$2000 less in 
people with T2D who performed physical 
activity ≥2 times/week vs. <1 time/week.19  
Thus, regular physical activity, a critical 
cornerstone of T2D treatment, may actually 
generate cost savings.20   
12.1.2. Why improve function?  PFLs predict 
disability, loss of independence, and 
premature mortality for adults.21-23  Regular 
physical activity can preserve function and 
reduce these adverse outcomes.24-27 
12.1.3 Why develop a treatment specifically for 
adults with T2D?  Adults with T2D develop worse 
physical function at an earlier age than their 
nondiabetic peers,22,28 and regular physical 
activity is one of the only effective 
interventions.24-27,29  Adults with T2D may 
develop premature PFLs due to specific factors 
associated with T2D8,22,30-40 (Figure 2).  Physical 
activity programs for adults with T2D and PFLs 
need to assess participants’ balance, cognition, 
and symptoms during ambulation in order to 
avoid enrolling participants who are unsafe to 
perform physical activity independently.24,41   
Because regular physical activity improves 
Abbreviations: Type 2 Diabetes (T2D); Physical function limitations (PFLs); Patient-
centered Medical Home (PCMH); Social Cognitive Theory (SCT) 

3 
 
glycemic control,42-44 treatment programs for adults with T2D should also monitor for glucose trends during the 
program and adjust medication doses as needed to avoid hypoglycemia.  Existing physical activity programs 
have not always included these important safeguards — in part, because they were not integrated into 
clinics.24  The proposed K23 trial will include these screening and treatment monitoring safeguards. 
12.1.4 Why should we deliver an intervention in clinical practices?  There are several reasons why clinical care 
settings are a highly relevant way to deliver interventions to treat adults with T2D and sedentary behavior.  
Clinical practices have key implementation features of capability, motivation, and opportunity.45,46  Despite 
these features, primary care clinics do not deliver evidence-based counseling programs due to several 
concerns, such as: excessive staff and clinician burden, lack of reimbursement, and lack of training for 
clinicians/staff to deliver counseling.47-49  To integrate an activity intervention in clinics, we need to develop 
programs that address these barriers in a way that may be replicated in other systems.    
      One way to address these barriers is developing at the national level. Primary care clinics have evolved 
dramatically over the past decade to better identify certain patient populations at high risk for disease — and 
proactively treat them.  This model of care is termed the patient-centered medical home (PCMH), and its 
prevalence is growing rapidly.50,51  An important PCMH characteristic is to use teams to manage patients’ 
health.  For example, PCMHs employ special health promotion clinic staff who call patients to address specific 
health targets (e.g., schedule routine diabetes visits, provide simple lifestyle counseling).52-54   Using teams 
offers lower cost alternatives to treat sedentary adults with T2D: it costs less for health promotion clinic staff to 
deliver counseling compared to clinicians; also, clinicians can remain engaged to see patients in clinic to 
monitor treatment — a unique capability that we leverage in the proposed K23 (Figure 3).  If effective, this 
K23 treatment model could be implemented in other PCMH clinics nationally.  Clinics that are not PCMHs 
could also feasibly adapt this model and designate a clinician to deliver the counseling — but greater costs to 
the clinic and excessive clinician burden make the proposed K23 approach more optimal.  The motivation for 
clinic leadership to deliver interventions is to improve quality of life and preserve functional independence for 
patients.  The opportunity is to deliver a relatively simple yet impactful intervention in a way that provides 
repeated counseling to patients — regular and repeated counseling is important to change behavior.55-59 
Another opportunity is to deliver this treatment in a way that overcomes a translational barrier — 
reimbursement for in-person visits.  Payers will likely be interested in this type of program due to the potential 
to prevent costly falls in adults with T2D and PFLs.29 
12.1.5 Adapting effective physical activity interventions for populations with T2D 
Social Cognitive Theory (SCT) has guided the behavioral interventions of many prior RCTs that improved 
physical activity behavior, including the VA Learning to Improve Function for Elders (VA LIFE) trial and the 
tailored counseling methods of DiLoreto et al.24  The proposed K23 intervention includes SCT-informed 
tailoring to overcome physical activity barriers and promote facilitators instead of a prescriptive “one-size fits 
all” approach (Figure 4).60  SCT considers behavior as an interplay between social/environmental factors, 
individual cognitive factors, and behavioral training 
(Figure 4).61,62  With regard to increasing physical 
activity in adults with T2D, the role of tailoring to 
promote activity facilitators or “outcome expectations” 
is particularly important to address barriers such as 
fear of injury and perceived difficulty with 
exertion.63,64  We also need to address potential T2D-
specific facilitators such as motivation to reduce 
medication dosage and to prevent diabetic 
complications.65-67  The Aim 1 pre-implementation 
phase will engage an expert advisory panel to adapt 
the K23 intervention to include tailoring to these and 
other T2D-specific barriers and facilitators — while 
ensuring the intervention remains simple enough for 
health promotion clinic staff to use. 
11.1.7 Summary of Significance:  One important way 
to reduce the burden of CV morbidity and premature mortality in people with T2D is to increase physical 
activity.  Evidence-based behavioral interventions have increased physical activity2,17 and have also improved 

4 
 
cardiorespiratory fitness2 and stroke outcomes17 in RCTs of people with T2D.  However, in order to widely 
translate physical activity interventions for people with T2D, interventions need to be more affordable, less 
resource-intensive, and more integrated with clinical care than the behavioral interventions tested in RCTs to 
date.3,4  We propose an important next step to allow integration of behavioral interventions into clinical care - to 
develop simple, valid methods to systematically identify and assess participants’ barriers and facilitators.   
     My K23 research objective is to determine the feasibility and effectiveness of a Social Cognitive Theory-
based behavioral counseling intervention (Aims 1-2) integrated into the primary care setting.  The proposed 
research is significant because it develops an intervention that is evidence-based yet brief enough to be 
implemented in clinical practice for a population with disproportionate CV risk (T2D).  The proposed work also 
addresses NHLBI Challenge 3.1 by identifying motivational factors related to physical activity – a priority 
behavioral risk factor for CV disease – in order to inform intervention strategies. 
  
12.2 INNOVATION 
I recently received Hartford Foundation funding to adapt the VA LIFE intervention24 and pilot-test having health 
promotion clinic staff deliver it to older adults with PFLs — the CU LIFE pilot trial.  The CU LIFE pilot provides 
an infrastructure that we propose to expand in the K23 to fully integrate an evidence-based physical activity 
intervention into primary care.  The chief K23 innovations/advantages are detailed in bold italics (Table 4). 
 
12.3 APPROACH 
12.3a. OVERALL RCT STUDY DESIGN  The overarching goal of this proposed research is to determine 
whether an evidence-based intervention that is reimbursable in U.S. clinics will improve physical activity and 
physical function.  To our knowledge, no studies have fully integrated these research programs into clinical 
practice.  Thus, we designed this study to determine the effectiveness (Aim 1) and acceptability/time burden 
(Aim 2) of integrating an intervention for adults with T2D.  For Aims 1-2, we will assess outcome measures at 
time = 0 (baseline) and time = 3 months (post-intervention).  We provide a detailed timeline for our proposed 
research procedures (Table 5) to complement the timeline of training and career development activities in 
section 4. (Career Development Plan) 
Table 4. Innovation of proposed Huebschmann K23 
 
VA Learning to Improve Function 
for Elders (VA LIFE) 
Funded CU LIFE pilot trial            
(PI – Huebschmann) 
Huebschmann K23 proposal 
Study population 
Sedentary adults 70-92 years    
(n = 398, 34% with diabetes) 
  
 
Sedentary adults 65-85  years, 
with or without T2D; and with 
PFL of slow walk speed 
(Enrolled n = 2 in first month, 
none with T2D; proposed n=25) 
Sedentary adults 50-85 years with 
T2D 
(n = 130 proposed to enroll) 
Innovation from 
prior work 
Delivered behavioral counseling 
by phone:               
1) Effectively increased physical 
activity and improved function;  
2) Less burden for participants 
than attending supervised 
exercise programs 
 
 
Exclusion Criteria screening: 
Research staff screen patients 
for eligibility 
Counseling delivered by: 
Research staff with behavior 
counseling training 
Integrate phone counseling 
intervention into clinics:  
1) adapted VA LIFE intervention 
for delivery by health promotion 
clinic staff; 
2) With physical therapy mentor 
input, added exercises that resist 
body weight  to improve strength 
more so than Theraband© 
exercises used in VA LIFE  
Exclusion Criteria screening: 
Research staff screen patients 
with PFLs for eligibility 
Counseling delivered by: 
Health promotion clinic staff who 
received training to deliver a 
brief, tailored intervention to 
adults with PFL 
1) Integrate screening into clinics 
2) In-person treatment visit 
enhances safety and provides 
reimbursement potential 
3) Robust mechanistic 
effectiveness assessment (Aim 1) 
4) Optimize CU LIFE counseling to 
address individual barriers and 
facilitators specific to T2D 
Exclusion Criteria screening: Clinic 
physician assistant assesses for K23 
eligibility during special “Stay Strong” 
clinic visit for sedentary adults with 
T2D  
Counseling delivered by: Health 
promotion clinic staff who will receive 
training to deliver a brief, tailored 
intervention to sedentary adults with 
T2D 
Next steps 
 
Huebschmann K23 proposal 
Future R01 – see section 12.3m. 

5 
 
 
 
12.3b. ADAPTATION OF THE SCREENING ALGORITHM AND INTERVENTION FOR PRIMARY CARE 
 Because we are adapting the pilot CU 
LIFE intervention that is currently coordinated 
by research staff, we will need a pre-RCT 
adaptation phase to fully integrate the study 
procedures into the clinic.  In this adaptation 
phase, the PI will meet monthly with an expert 
advisory team representing K23 mentors in 
physical activity in T2D (Dr. Regensteiner), 
endocrinology (Dr. Reusch), physical therapy 
(Dr. Stevens-Lapsley), physical activity 
behavior counseling (Dr. Dunn), health 
promotion clinic staff who will deliver the 
counseling, and clinic physician assistants 
who will conduct the screening and monitor 
the treatment. 
 Clinical screening algorithm (Table 6): First, 
we will optimize the clinical screening 
algorithm in consultation with our expert 
advisory team.  Next, in months 4-6, the PI will 
train four clinic physician assistants (n = 2 from 
each clinic) to conduct the screening.  The PI will field test the optimized screening algorithm until we achieve 
an outstanding κ inter-rater reliability ≥0.81.69  
Table 5.  K23 project timeline   
Year 
Quarter 
 
Year 1 – 2015                    
Year 2 – 2016                  
Year 3 – 2017 
Quarter 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Project Phase 
 
 
 
 
 
 
 
 
 
 
 
 
Adaptation of screening and intervention for primary care 
x 
x 
 
 
 
 
 
 
 
 
 
 
Pilot-test intervention 
 
x 
 
 
 
 
 
 
 
 
 
 
Patient recruitment and Screening  
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Randomization of patients to intervention or usual care 
with accumulated participant goal (n) per quarter  
 
5 
20 
35 
50 
65 
80 
100 
115 
130 
 
 
Data analyses of primary and secondary outcomes (Aim 1) 
 
 
 
 
 
 
 
 
 
 
x 
x 
Process measure evaluation in participants and clinic 
system (Aim 2) 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
K23 milestones: future grant submissions and manuscripts.  
See Table 3 timeline in “Career Development plan”  
 
A 
 
 
B 
 
R01 
 
 
R01 
 
C 
Table 6: Proposed K23 Exclusion criteria for Screening Visit - to be 
optimized in pre-RCT Adaptation phase  
Dementia (Folstein Mini-Mental Status Exam < 24)24 or clinical diagnosis 
Excessive fall risk: Cannot hold semi-tandem stance for ≥10 seconds 68 
T2D-related safety concerns: Prior diabetic foot ulcer; Charcot foot; 
asymptomatic hypoglycemia20 
Severe uncontrolled hypertension (BP >180/100)24 
Excessive hearing or visual impairment for counseling24 
Limited life expectancy: active treatment for malignancy24 
Performs regular physical activity ≥20 minutes on ≥3 days/week, as per 
valid screening question from Activity Counseling Trial55:  “Do you 
regularly participate in any physical activity such as walking, running, 
aerobic dance, swimming, or sports at least 3 times per week for 20 
minutes or longer each time?”.   
Conditions that may limit response to intervention: chronic liver disease 
(transaminases >2 times normal limits), chronic kidney disease (serum 
creatinine >1.5 mg/dl or urine microalbumin >30 mg/g), anemia (Hb < 11 
mg/dl), or pregnancy  

6 
 
Tailor counseling to T2D needs: In months 
0-3 of the pre-RCT Adaptation phase, we 
will also optimize the evidence-based 
clinical counseling program used in clinical 
practices by Di Loreto et al (Table 7).70  
One area of optimization will be to increase 
participant self-monitoring and 
accountability through the use of wearable 
activity monitors that provide feedback to 
participants on how well they are meeting 
their goals.  Another area of optimization is 
to add diabetes-specific motivational 
factors to the counseling, such as fear of 
foot ulcers/hypoglycemia (barrier). In 
months 4-5, the PI will pilot-test the 
intervention with participants to obtain 
participant feedback on optimal methods of 
presenting the intervention content, such 
as formatting of materials that describe 
potential motivators, barriers, and physical 
activity programs (Table 7).  In month 6, 
Dr. Dunn will aid the PI to train health 
promotion clinic staff to deliver the 
intervention in month 6 (Phase 2b).  Training will include:  
 
how to use brief motivational interviewing techniques to increase physical activity behavior71 
 
how to tailor intervention content to the participant’s stage of change72 (e.g., contemplation, action) 
 
how to tailor intervention to unique individual barriers/benefits of physical activity 
12.3c. RECRUITMENT 
 
 For the past 5 years, the University of Colorado has used designated health promotion clinic staff to 
meet the prevention-focused needs of its primary care clinics (see description of PCMH in Significance).  
These staff receive monthly customized reports of primary care patients who warrant outreach.  These reports 
are generated automatically from the electronic health record by a computer program.   
 
As of May 5, 2014, there are currently 1400 patients in our two University of Colorado Internal 
Medicine clinics who may qualify for the proposed study based on a T2D diagnosis and age of 50-85 years — 
population estimates suggest ~60% of these patients will be sedentary.58,73  On a monthly basis during the 
K23, the health promotion clinic staff will receive a list of clinic patients who meet inclusion criteria that is pulled 
from the electronic health record by an electronic query: adults aged 50-85 years with ICD-9 diagnosis code for 
T2D. 
 
The health promotion clinic staff will call interested and eligible adults from the list to offer a special type 
of primary care clinic visit: “Stay Strong: Learning to Improve Physical Function and Prevent Falls (“Stay 
Strong” visit).  The purposes of the “Stay Strong” visit are: 1) to provide standard-of-care fall prevention 
information to all sedentary adults with T2D; 2) to screen for K23 eligibility.  This approach is consistent with 
the PCMH focus to proactively target the health needs of specific patient subpopulations.74 
 
12.3d. SCREENING 
During the “Stay Strong” clinic visit – a trained physician assistant reviews fall prevention and community 
physical activity options, and uses the optimized screening algorithm (Table 6) to assess exclusion criteria.  
Our clinics will bill insurance for this clinic visit and for the other in-person clinic visits (Visits 4, 6, and 8)  for the 
services provided by the physician assistant.  We will not bill insurance for the phone counseling services 
provided in visits 4-9; the costs for the staff time needed to provide phone counseling are covered by the grant. 
12.3e. ENROLLMENT 
Study Population: Patients who are interested in participation and meet inclusion criteria (T2D, age 50-85 
years) and do not meet exclusion criteria (Table 6) will attend an enrollment visit (Visit 1, V1).  After informed 
Table 7: Proposed K23 Intervention Counseling content - to be optimized in 
pre-RCT Adaptation phase  
Motivation: Review health benefits of regular activity for people with diabetes 
– tailored to emphasize benefits of greatest interest to individual 
Self-efficacy: collaborate with each participant to identify activity program that 
participant can confidently perform - advance weekly goals realistically by 2-
10 min/week 
Pleasure:  Ask about prior exercise experiences to rule out boring/painful 
activities.  Suggest several indoor and outdoor aerobic activities –participant 
selects ≥2 enjoyable activities 
Support:  Suggest walking or other activity with family/friends. 
K23 Optimization: Wear FitBit© throughout the 12-week intervention to 
provide motivational reminders 
Identify personal pros/cons of change: Probe understanding of value of 
making this change. Assess uncertainty about committing to this change and 
perceived barriers to activity.   
K23 Optimization: After open-ended questions, inquire about T2DM-specific 
barriers of painful activity, fear of injury, and fear of hypoglycemia 
Overcome barriers:  Rather than suggesting solutions, counselor invites 
participant to solve the barriers to activity he/she identified.  Counselor adds 
advice on time management strategies. 
Tracking: Participant records daily type and times of activity 
K23 Optimization: Wearable device simplifies ability to track activity  

7 
 
consent, participants will undergo 1:1 patient-level randomization to the intervention or usual care group. 
(Figure 5)  
Study Settings: Enrollment (V1), Baseline testing (V2-3), and Exit testing (V10-11) will be conducted in the 
CCTSI outpatient Clinical Translational Research Center.   
12.3f. INTERVENTION GROUP 
 
The proposed intervention is based on 
SCT (Figure 4 in “Significance”) and seeks to 
increase physical activity and improve strength by 
addressing individual, behavioral, and 
social/environmental factors.   The health 
promotion clinic staff will deliver counseling by 
phone on a bi-weekly basis — a clinic physician assistant will coordinate with the counselor during in-person 
clinic visits (Figure 3 and Table 8), teach participants to perform strengthening exercises; and assess for safety 
concerns, such as hypoglycemia.  We optimized the existing VA LIFE intervention in our funded CU LIFE pilot, 
by simplifying the VA LIFE counseling guide for delivery as brief, tailored counseling by health promotion clinic 
staff (see Appendix), and by adding strengthening exercises that engage multiple muscles (see Appendix). To 
ensure the intervention is brief enough for clinical use and to incorporate T2D-specific barriers and facilitators, 
we will make further adaptations in the pre-RCT Adaptation phase, as described above in 12.3b.   
 
In addition to behavioral counseling targeting SCT constructs (Figure 4 in Significance), counselors will 
assist participants in the intervention group to set specific goals for physical activity in a paper log and on an 
electronic FitBit activity tracking device (see Appendix).  Participants will record their actual physical activity 
next to their goals for easy review during counseling visits. Health promotion clinic staff will encourage 
participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of 
moderate intensity activity (e.g., brisk walking) and 2-3 days/week of strength activities consisting of cycles of 
5-10 repetitions of sit-to-stand, toe stand, chair dip, and side step-down (see Appendix).75  Although achieving 
guidelines is a long-term physical activity goal, counselors will help patients to work towards this goal 
systematically but gradually. Participants and counselors will determine each person’s rate of physical activity 
increase to accommodate unique factors associated with their T2D, functional limitations, and fitness.  
 
12.3g. USUAL CARE GROUP 
Participants in the usual care arm will receive three mailings during the intervention phase (Table 7).  Health 
promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that 
address general healthy aging topics: i.e., advanced directive care planning, vision and hearing changes with 
aging, respectively.  These mailings will be the only research contacts with participants during the 12-week 
intervention phase. 
 
ur 
Table 8 Study visit activities, by study group 
Visit Phase 
Intervention  
Usual Care  
1 
Enrollment 
Consent, baseline testing  Same as 
intervention arm 
2-3 
Baseline 
time (t) = 0 
weeks 
Baseline covariate and 
outcome testing 
Same as 
intervention arm 
4 
t = 2 weeks 
In-person clinic visit * 
with phone counseling†  
None 
5 
t = 4 weeks 
Phone counseling† 
Print mailing on 
aging topic 
6 
t = 6 weeks 
In-person clinic visit * 
with phone counseling† 
None 
7 
t = 8 weeks 
Phone counseling† 
Print mailing on 
aging topic 
8 
t = 10 weeks 
In-person clinic visit * 
with phone counseling† 
None 
9 
t = 12 weeks 
Phone counseling† 
Print mailing on 
aging topic 
10-
11 
Exit testing,    
t = 3 months 
Exit covariate and 
outcome testing 
Same as 
intervention arm 
*Clinic visit is to teach and monitor form for strength exercises, to 
assess for safety concerns during treatment, and to coordinate with 
health promotion clinic staff counselor (see Figure 3 in Significance) 
†Phone counseling delivered by health promotion clinic staff  

8 
 
12.3h. PRELIMINARY DATA PERTINENT TO THE APPLICATION  
I and other study team members have collected study data in primary care clinical settings and clinical trial 
settings that demonstrate the feasibility of collecting the proposed measures.  In addition, these data suggest 
that the proposed screening and behavioral intervention can be implemented in primary care systems that use 
health promotion clinic staff.  Finally, these data suggest that the proposed intervention will improve the 
proposed physical activity measures that are strongly linked to physical function. 
 
Preliminary data – Behavioral counseling by health promotion clinic staff  I led an RCT for patients with 
uncontrolled hypertension of an intervention that included health promotion clinic staff counseling.  Health 
promotion clinic staff called intervention patients and delivered brief, tailored counseling about lifestyle 
measures to control blood pressure, and arranged a primary care clinic visit.54  We did not contact usual care 
patients.  Because this intervention improved process outcomes related to blood pressure control and had high 
acceptability to patients and clinicians,54 our clinics have continued this hypertension management process. 
Preliminary data -Physical activity and physical 
function outcome measures  I have preliminary 
unpublished data on physical activity, physical 
fitness and physical function performance data in 
an ongoing study of sedentary, overweight older 
adults aged 50-70 years with and without T2D 
(Table 9).    We measured physical activity and 
function by methods proposed in this application — 
accelerometer and the time needed to complete a 
400-meter walk at the most rapid pace possible.  
As others have published,20,24,26,56-58,76 we also 
found strong correlations between higher levels of 
physical activity measured by accelerometer (K23 
1° outcome) and better physical function, as 
measured by a shorter time required to complete a 
rapid 400-meter walk (r = -0.52).  These data 
support the conceptual framework of this study (Figure 2) by demonstrating the relationship between the 
outcomes of physical activity and function.    
 
Preliminary data on 4-week phone-based activity counseling tailored to Dishman barriers surveys responses 
Separate from our preliminary data in Tables 8-9, we have pilot-tested the delivery of tailored telephone-based 
counseling to 3 older adults with T2D (aged 67.3 ± 7.5 years, mean ± SD).  Over 4 telephone-based 
counseling visits tailored to each participant’s physical activity barriers responses,77 we demonstrated an 
increase in combined moderate-vigorous physical activity levels by 142 minutes/week across 3 participants 
(from 65 ± 80 to 207 ± 87 minutes/week, mean ± SD). 
Preliminary data on improved activity and function in response to interventions 
Study team mentors (Judith Regensteiner, PhD. Andrea Dunn, PhD) have been active investigators in several, 
large behavioral physical activity interventions in clinical trials, primary care, and community settings that 
demonstrated improvements in outcomes of physical activity and physical function.55-59  These trials have all 
used common behavioral tools of regular, repeated staff contact with participants to set goals, track activity, 
and overcome barriers to activity.  Some of these trials included older participants with some physical 
functional impairments similar to those found in the participants we propose to enroll, although our trial will be 
substantively different by its use of clinical staff: 1) to identify patients who might safely participate; 2) to deliver 
such interventions.  
Summary: Taken together the preliminary data collected support the idea that an intervention in a clinical 
setting which allows for screening to identify appropriate patients and then implementing a clinic based 
intervention has the potential to improve physical activity and function in sedentary adults with T2D. 
 
 
Table 9 Population Characteristics for Preliminary Data on 
Correlations between Physical Function and Physical Activity 
 
Overweight, sedentary 
adults (n = 12) 
T2D (%) 
58 
Age (years, mean (SD)) 
61.1 (5.4) 
BMI (kg/m2, mean (SD)) 
30.2 (2.6) 
Accelerometer-measured Physical 
activity (Combined moderate-vigorous 
intensity minutes/week, mean (SD)) 
91.0 (97.3) 
Cardiorespiratory fitness (maximal 
oxygen uptake, ml/kg/min) 
21.9 (1.5) 
Physical function: Rapid, timed 400-
meter walk, seconds (mean, SD) 
300.4 (56.7) 

9 
 
12.3i. OUTCOME MEASURES (see Table 10 on next page) 
12.3j. POWER CALCULATION AND DATA ANALYSES FOR AIM 1 (EFFECTIVENESS) 
Power Calculation: We used PASS version 11 to calculate power for the physical activity outcome.78  Aim 1 
was powered based on a previously observed effect size of Cohen’s d = .61 when comparing a physical 
activity intervention to an education control group on physical activity of moderate-to-vigorous intensity79 
among older, obese adults.  Assuming similar sized effects in the current study and a two-sided alpha of 0.05, 
the proposed sample size of n=90 will provide over 80% power to detect differences between the activity 
intervention and usual care for Hypothesis 1.  If our effects match that of our preliminary data (increase in 
combined moderate-vigorous physical activity levels by 142 minutes/week across 3 participants (from 65 ± 80 
to 207 ± 87 minutes/week, mean ± SD), then we will have over 95% power to detect differences between the 
activity intervention and usual care.  Enrollment of n=130 was planned to allow for up to 30% attrition.  For Aim 
1b, the proposed sample size will be sufficient to obtain stable means and standard deviations in order to 
calculate an accurate effect size estimate for physical function outcomes.     
Data analysis: Before conducting the analyses by aim, we will assess descriptively and graphically the mean 
and distribution of each study outcome and covariate, in order to assess for outliers and skewed distributions.   
If variables are not normally distributed, we will consider logarithmic transformation. 
Aim 1 Data Analysis 
Hypothesis 1. Using intent to treat principles, we will test for differences between the intervention and usual 
care groups on physical activity at the 3 month assessment.  We will assess the intervention effect size of 
change in physical activity from baseline testing to 3 months using an ANCOVA model with adjustment for age; 
covariates from Table 10 (e.g., cognitive processing speed); and each participant’s baseline score.  Adjustment 
for baseline score is useful in this relatively small RCT to eliminate any potential baseline differences between 
groups that may occur despite the randomization procedure.  We expect that the mean physical activity at 3 
months will be significantly higher in the intervention group than in the usual care control group. Every attempt 
will be made to ensure high retention rates at posttest, although some attrition is to be expected.  The level and 
patterns of missing data will be evaluated relative to intervention condition and other baseline characteristics to 
determine whether there is systematic bias in the missing data. If necessary and appropriate, based on the 
level and patterns of missing data, state-of-the-art techniques (e.g., multiple imputation) will be used. 
Aim 1 secondary outcomes. The analyses for Aim 1 secondary outcomes will be used to detect trends and to 
provide necessary data to calculate the sample size needed to detect differences in a larger RCT. We will 
assess the intervention effect size by calculating a Cohen’s d effect size comparing the means of the two 
groups at the three-month follow-up.  We will use separate ANCOVA models to assess pre-post intervention 
changes in the following outcomes listed in Table 10:  physical function by 400-meter rapid gait speed 
(differentiates adults with higher baseline function); Short Physical Performance Battery (differentiates adults 
with lower baseline function); intermediate physical activity behavioral constructs from SCT; intermediate 
functional outcome (lower extremity strength); and metabolic outcome (Hemoglobin A1c). 
 
 

10 
 
Table 10.  Outcome, Predictor, and Covariate Measures for Huebschmann K23 
Outcome 
Instrument 
Variable  
Measure 
Physical Activity outcomes 
 
 
  
Objective physical activity     
Actigraph GT3x+ accelerometer measures physical activity 
objectively as minutes/week of moderate intensity and vigorous 
intensity physical activity, respectively.80  We define moderate 
intensity levels by the methods of Freedson et al.81 Participants 
will wear the Actigraph for a 7-day period pre/post intervention. 
We will ensure measurement during a typical 7-day period and 
will use standard wear-time validation procedures to ensure 
valid weekday and weekend data. Actigraph data will be 
collected on the 7 days between physical function and VO2max 
testing. 
Continuous 
Aim 1         
1° outcome 
Physical activity behavioral 
constructs from SCT 
Standard survey measures to assess the following physical 
activity behavior assessments of constructs from SCT:  
Continuous 
Aim 1 
Predictor 
variable: 
physical 
activity (PA 
predictor) 
Self-efficacy to do physical activity of increasing duration;82,83 
Social-environmental support is a valid measure of how 
others support one’s healthy lifestyle choices;84   
Lower barrier scores on the Dishman physical activity 
barriers survey are associated with higher levels of physical 
activity;77  Physical Activity outcome expectancy for elders 
survey includes positive elements of physical activity for older 
adults, including health-related factors – better scores are 
associated with higher physical activity levels85  
Physical Function outcomes 
 All physical function outcomes will be measured after a 4-hour 
fast and under the same conditions pre/post intervention. 
 
  
Cardiorespiratory fitness 
(VO2max) 
To assess cardiorespiratory fitness, we measure breath-by-
breath utilization of oxygen (VO2) and carbon dioxide (VCO2) 
with a Medgraphics Ultima CPX metabolic cart (Minneapolis, 
MN).  We also measure blood pressure (auscultation), and 
cardiac status (12-lead ECG).  To determine VO2max, subjects 
perform treadmill exercise to exhaustion using a standard 
protocol.86,87 We define VO2max per standard practice.86  
 
 
Physical function  
400-meter rapid gait speed test measures fitness and mobility; 
it is sensitive to change for adults with minimal to mild 
functional impairment; predicts disability and mortality.88 
Physical function measures will be assessed on a separate 
study date from the VO2max testing.  
Continuous 
Aim 1  
2°outcome  
Physical function  
The Short Physical Performance Battery (SPPB) measures 
function with the following valid subscales: balance, usual 
walking speed, and repeated chair rise.  The SPPB is 
sensitive to change for adults with moderate to severe 
functional impairment, and predicts disability and 
mortality.68,89   
Ordinal, range 
0-12 
Aim 1  
2°outcome  
Lower extremity strength 
Lower extremity strength will be measured as leg extensor 
(quadriceps) and leg flexor (hamstring) strength using Dr. 
Stevens-Lapsley’s laboratory’s established techniques.38,90 
Continuous 
Aim 1  
Function 
predictor 
Grip strength 
Hand grip strength will be measured by dynamometer.91  
Continuous 
Aim 1 
2°outcome 
Metabolic control outcome 
  
 
  
Hemoglobin A1c 
Average glycemic control measured by standard methods92 
Continuous 
Aim 1 
Covariates for adjustment 
  
  
  
Depression symptoms 
Center for Epidemiologic Studies Depression Scale measures 
depressive affect severity and is valid in people with93,94 and 
without T2D.95,96 
Continuous 
Aim 1  
covariate for 
adjustment 
Lower extremity arthritis pain 
symptoms 
Western Ontario and McMaster Universities Arthritis Index– 
valid measure of knee and hip pain and stiffness.97                       
Continuous 
Aim 1 
covariate 
Cognitive processing speed 
Stroop test –measures cognitive processing speed as a valid 
predictor of cognitive function in adults with and without T2D.98-
100 
Continuous 
Aim 1 
covariate 

11 
 
 
12.3k. ANALYSIS OF ACCEPTABILITY OUTCOMES (Aim 2 and Safety analysis) 
 
Aim 2 Statistical analysis:  We will use surveys to descriptively assess the pilot RCT outcome of intervention 
acceptability.  Acceptability levels ≥ 80% for patients (Hypothesis 2a) and for clinic providers 
(Hypothesis 2b) will support the intervention as acceptable.103  Because acceptability may vary by clinic 
staff/provider type due to differing intervention burden/benefits by role, we will assess acceptability levels 
separately among different types of clinic staff/providers (i.e., medical assistants, primary care providers, 
chronic disease management counselors, physician assistant counselors, clinic leaders).103 
Aim 2 Descriptive analysis of time burden: For each treatment visit, health promotion clinic staff will document 
the time required to complete the intervention for patients, clinic providers (in-person treatment visits), and 
clinic staff (telephone counseling).  If the intervention is effective, these time burden estimates could be used to 
generate future cost analyses. 
Safety analysis: For ethical reasons, in addition to the acceptability outcomes addressed in Aim 2, we will 
monitor for study group differences in safety-related outcomes, in order to assess for any potential study harm. 
We selected the following safety outcomes based on relevant use in prior trials and per expert description of 
safety concerns in T2D; falls, musculoskeletal injuries, severe hypoglycemia (glucose <60 mg/dl or 
hospitalization/Emergency department visit for hypoglycemia.20,24,57  At study exit visit 9, we will ask 
participants if any of the following safety-related outcomes occurred since baseline testing was completed in 
visit 2: fall requiring clinical evaluation; fall that did not require clinical evaluation; musculoskeletal injury 
requiring clinical evaluation; musculoskeletal injury that did not require clinical evaluation; severe hypoglycemia 
(glucose <60 mg/dl or clinical evaluation for hypoglycemia), foot ulceration.  For each safety outcome 
measured, we will descriptively report these as both dichotomous outcomes (Yes/No) as well as the frequency 
of safety events (e.g., number of hypoglycemic episodes).  We will use ANCOVA to obtain preliminary data on 
the group differences in safety outcomes with adjustment for baseline conditions that may increase safety risk.  
Baseline conditions that may increase safety risk include the following: baseline moderate-to-severe 
impairment on SPPB (baseline score <10), prior history of fall, slowed cognitive processing speed). 
12.3l POTENTIAL PROBLEMS AND ALTERNATIVE STRATEGIES  We have planned alternatives for 
potential problems that may arise.  For example, if participants report new medical concerns or symptoms 
during the telephone counseling sessions with the health promotion clinical staff, staff members will transfer 
the patient to the clinic triage nurse to evaluate the patient’s symptoms.  Also, if participants report new 
musculoskeletal pains to the health promotion clinic staff, the staff member will send an electronic health 
record note to the physician assistant conducting the in-person treatment visits to advise the patient on any 
recommended treatment or activity restrictions.         
12.3m EXPECTED OUTCOMES/FUTURE DIRECTIONS  As adults with T2D age, they develop PFLs at an 
earlier age than their nondiabetic peers — in part due to the sedentary behavior associated with T2D.  PFLs in 
older adults increases risk for institutionalization, mortality, and poorer quality of life so that people with T2D 
are particularly at risk.  The proposed goal is to improve the physical function mediator of physical activity in 
older adults with T2D and sedentary behavior in primary care settings.  Our rationale is that behavioral theory-
 
DEXA scan 
DEXA will allow the calculation of body composition as fat-free 
mass and total mass so that we may report exercise 
performance levels standardized to these body composition 
measures. 
Continuous 
VO2max 
covariate for 
adjustment 
Cognitive executive function 
Behavioral Dyscontrol Scale – valid measure of executive 
function in adults with and without T2D.101,102 
Continuous 
Aim 1 
covariate 
Process outcomes 
  
  
  
Acceptability 
Percent of intervention patients who would recommend 
intervention103; Percent of clinical providers/staff who 
recommend continuing to offer the intervention to patients103 
Percentile 
Aim 2 
Time burden 
Patient time required for each intervention visit103; 
Staff/provider time required for each intervention visit103 
Continuous 
Aim 2 
Safety outcomes 
Participant report of outcomes after baseline testing: falls, 
musculoskeletal injuries, foot ulcers, hypoglycemia20,24,57 
Continuous 
Safety 

12 
 
informed interventions increase physical activity and function.  What patients need is the translation of these 
interventions to settings with the greatest reach and impact —  in clinical practice.  We will integrate a 
behavioral intervention into primary care clinics to treat sedentary adults with T2D.  If the K23 preliminary data 
suggest that the intervention will improve physical function, the resultant R01 will be powered to detect 
improvements in physical function and to assess intervention costs and other outcomes relevant to future 
implementation.  Even if the K23 intervention does not improve physical function, we will observe individual 
changes in physical function that will vary by factors such as baseline levels of predictors of activity and 
function or covariates (Table 10).  In this case, the future R01 would assess the mechanisms of change in 
physical function in sedentary adults with T2D and would more precisely estimate subpopulations that are 
more likely to respond to an intervention.  For example, if K23 participants with higher baseline muscle strength 
were more likely to improve their 400-meter walk function outcomes than participants with lower muscle 
strength, the R01 would assess the mechanisms of improvement in 400-meter walk with regard to baseline 
muscle strength and predictors of muscle strength such as insulin resistance and age,33,104 and it would also 
assess the range of baseline muscle strength that predicts response to the intervention).  In addition, we would 
optimize the K23 intervention to improve its effects on outcomes that did not respond; for example, if hamstring 
muscle strength improved but quadriceps muscle strength did not improve, we could alter our strengthening 
exercises recommendations to increase the number or frequency of quadriceps strengthening exercises.   
          This scientific proposal directly addresses a “key research objective” that was developed in the 2011 
Federal Diabetes Mellitus Interagency Coordinating Committee’s strategic plan: “to determine optimal 
strategies to improve and sustain lifestyle strategies for older adults with diabetes”.  By determining the 
effectiveness of this program and by filling my training gaps, this K23 proposal has great translational potential 
to improve the health of sedentary adults with T2D. It also prepares me to be a national leader in the 
implementation of evidence-based physical activity programs at other clinical sites.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

13 
 
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