Feasibility and Acceptability of a Web-based Physical Activity for the Heart (PATH) Intervention Designed to Reduce the Risk of Heart Disease Among Inactive African Americans
Phase: NA
Conditions: Cardiovascular Risk Factor, Prediabetes, Overweight and Obesity, Sedentary Behavior
Sponsor: University of Pittsburgh

 
 
Feasibility and acceptability of a web-based physical activity for the heart (PATH) 
intervention designed to reduce the risk of heart disease among inactive African Americans 
 
 
 
 
NCT04280783 
 
 
 
Date: October 27, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocols for the intervention and control groups. 
After randomization, each participant in the intervention group will be given a password-protected profile to 
access the PATH website and a detailed orientation on how to use all the resources included in PATH (see Table 
1). The control group will be introduced to Be Active Your Way booklet and newsletters which they will be 
encouraged to use for 12 weeks while awaiting the intervention. 
The treatment group: The PATH group will be granted password protected access to one of the 3 PATH 
levels based on their baseline fitness status. The intervention is designed to help participants increase their 
baseline PA via health coaching, self-monitoring and pragmatic workout videos that provide convenient options 
for overcoming socio-environmental barriers to PA. After randomization, the PA coach will work with each 
participant to develop their PA prescription guided by the FITT-VP principle1 which recommends the frequency, 
intensity, time/duration, type, volume and progression of PA regimen. The goal of the exercise prescription will 
be to increase baseline MVPA by ≥60min/week or 6000 steps/week over the course of the study. Our PA 
prescription process will begin by identifying a suitable PATH level for each participant based on their estimated 
maximum rate of oxygen consumption during incremental exercise (VO2 max).1 The VO2 max will be predicted 
using a validated non-exercise prediction model for peak VO2 (VO2 peak) whose covariates include sex, age, 
waist circumference, resting heart rate and PA index.2 Individuals with predicted VO2 max ≤ 35th percentile rank 
for their age and gender will be assigned to the Beginner PATH level (includes light intensity PA <3 METs). 
Those with VO2 max between 35th and 75th percentile rank will be assigned to Intermediate PATH level which 
includes moderate intensity PA (3-6 METs) in addition to the Beginner PATH content. Participants with VO2 max 
greater than 75th percentile rank will be assigned to Proficient PATH level which includes vigorous intensity PA 
(>6 METs) in addition to the Intermediate PATH content. After assigning PATH level, the PA coach will guide each 
participant in selecting their weekly PA goal and will help them plan to start slow with a plan to establish regular 
exercise frequencies of 3-5 days every week. The coach will also guide participants to select activities with 
intensity that help them progress along the PA continuum (i.e., sedentary to light PA to MVPA). To foster safety, 
participants will be instructed to use the Borg Rating of Perceived Exertion (RPE) Scale3 as a guide for adjusting 
the intensity of their PA regimen. The scale ranges from 6 (no exertion at all) to 20 (maximal exertion) and is 
embedded with each workout video on PATH. Specifically, the participants will be asked to maintain PA at 
perceived exertion ratings between 12 to 14 (i.e., moderate level of intensity) on the RPE Scale. To ensure 
gradual progression in PA intensity, each participant’s progress will be reviewed every 2 wks, and more intensity 
will be allowed, including transition to the next PATH level, when most workouts within the assigned PATH level 
are perceived to be “very light” (≤9 on the RPE Scale). Participants will be requested to rate each workout they 
engage in on the RPE scale. This method will ensure that the prescribed PA regimen for each individual is based on 
their physical ability and fitness status. Although the PA coach will provide solid examples of the combination of 
workout videos that could help participants attain their personalized goals, each participant will have access to 
all resources within their PATH level and will be encouraged to select a PA regimen that includes their preferred 
workout videos and other types of PA appropriate for their fitness. The workouts that are recommended by the 
PA coach and those selected by each participant as favorites will be featured on the personalized PATH 
dashboard. Box 1 illustrates a PA prescription for Mary, where in the first 2 wks her PA regimen includes her 
usual walks (40 mins of MVPA/wk or 4000 steps/week) and 10 mins of additional dance workouts each week. 
The PA prescription will be revised after 
every 2 weeks based on the progress 
made. Those who manage to increase 
PA by ≥10 minutes each week of MVPA 
or 1000 steps for 6 consecutive weeks will 
attain the study goal and their plan for the 
remaining study period will be to maintain 
the improved PA regimen. However, the 
participant can opt to continue with 
gradual increase in PA volume. To 
simplify 
access 
and 
support 
PA 
maintenance, the workout videos are 
organized in specific categories (e.g., 
walking, dance, steps aerobics) and can 
be sorted by duration and METs. To 
reduce risk of injury, the amount and 
intensity of PA will be increased 
gradually over the course of the study, as 
advocated by ACSM.4 Although there are 
no established standards on how to increase PA gradually, available evidence suggests that it is safe to increase 

MVPA by about 10 minutes or 1000 steps every week.4,5 Each participant will be provided near real-time data 
on their progress towards their weekly and monthly goals on the PATH dashboard. To complete the PA 
prescription, participants will provide their preferred schedule for receiving PA reminders and twice a month 
phone calls from the PA coach to monitor progress and revise PA goals. Participants will also be given contacts 
of the PA coach with instructions to reach out if they need help before scheduled calls. During the study period, 
participants will be encouraged to adhere to their PA goals and share their experiences on the PATH community 
forum moderated by the study staff. At the end of the study, we will survey participants for feedback on resources 
that were most helpful to them and ideas for improving the PATH intervention. 
Wait-list control group: Participants in this group will not have access to the PATH intervention until after 
12 weeks when they cross over. After randomization, the control group will be provided with a copy of the Be 
Active Your Way booklet, developed by the Centers for Disease Control (CDC) to help individuals integrate PA 
in their daily lives.6 The key strategies used in the booklet are outlined in Box 2. We have chosen this control 
strategy to mirror usual care where patients are provided with self-help handouts. The Be Active Your Way 
booklet was selected because it is evidence based, free to download and recommended by the CDC as a 
pragmatic self-help resource for promoting PA.6 In addition, 
the control group will receive bi-weekly newsletters focusing 
on general health. The control group data will help contrast the 
important aspects of our study, including differential ActiGraph 
use and retention rates between the control and intervention 
groups, as well as the trend in PA and cardiometabolic risk 
changes. After 12 weeks, the outcome assessments will be 
done, and the control group will be given access to the PATH 
intervention. Once given access to PATH, participants will be 
subject to all the study procedures described for the treatment 
group. No follow-up is planned after the post-intervention 
assessments for both the intervention and control groups. 
Expected results, potential pitfalls and solutions: Although 
a wait-list control design may artificially inflate the intervention effects in an efficacy trial,7 our feasibility study 
primary focus is on within-group changes. Therefore, a wait-list strategy may enhance retention and help control 
for passage of time and assessments8 without impacting study outcomes. Another potential pitfall is recruitment. 
However, based on our experiences, we do not anticipate significant difficulties recruiting women, but more 
proactive strategies will be needed to recruit men and minorities. To address the challenge, we have built 
relationships with strategic community stakeholders such as barbershops where men frequent, and the CTSI 
Community PARTners core which specializes on recruiting minorities. In addition, the remote nature of the 
intervention is likely to make the study appealing to men and other underserved populations with low participation 
in biomedical research. These strategies will help us attain our recruitment targets. To foster safety, our exclusion 
criteria will help exclude individuals who are unfit to engage in unsupervised PA. Moreover, the PA prescriptions 
will be personalized according to ability and preference. All participants will be educated on PA safety using ACSM 
Guidelines4 and will be given non-slip exercise mats. 
Screening assessments – Questionnaires will be used to assess barriers to exercise self-efficacy, PA 
readiness, medical history and risk of diabetes, PA habits, sleep patterns, depressive symptomatology, diet, 
fatigue, and stress. Table 1 outlines the specific data collection instruments and their timeline. These data will be 
used to evaluate eligibility and to describe lifestyle and other cardiometabolic factors typically related to PA. 
Measures of adherence and acceptability (Aim 1). Wrist-worn ActiGraph GT9X will be used to measure PA 
outcomes. Throughout the 12-week Study, participants will be asked to self-monitor their daily PA. The PA 
tracker will be worn on the wrist for at least 10 hours per day when a participant is awake. The tracker will be 
connected to the CenterPoint app which will help the study team monitor the participants’ progress throughout 
the study. Two weeks and one week before the end of the study, the study team will send reminders to 
participants (via text message, email, phone call and push notification) to wear their PA tracker for 7 days before 
they are scheduled for their end of study assessment. Adherence to PA self-monitoring will be indicated by the 
number of weeks with ≥4days (3 weekdays and 1 weekend day) of valid wear time (≥10hrs). PATH utilization data 
will be collected via Web analytics, while a post-intervention survey will assess intervention acceptability. 
Measures of PA and cardiometabolic outcomes – administered at baseline and 12 weeks (Aim 2). Body 
weight (assessed via Fitbit Aria 2 digital scale), waist circumference (assessed via Perfect Waist Tape Measure) 
and blood pressure (assessed via Omron Model BP7450) assessment will be done by the participant using the 
equipment shipped to their address by the study, and under the supervision of the study team via HIPAA 
compliant zoom video conference. The instructions for weighing will include asking participants to wear light 
clothing and stand bare feet on the scale’s footpads. The recorded weight will be available to the study team 
immediately and via Fitbit API. When taking the blood pressure, the participant will be instructed to apply the cuff 
Box 2. Be Active Your Way get started plan 
 
 
 
 
 

on the left bare arm, ensuring that nothing is constraining the arm above the cuff. The easy-wrap ComFit cuff 
used in Omron Model BP7450 fits standard to large adult arms ranging from 9 to 17 inches in circumference.6 
After applying the cuff, the participant will be asked to relax, sitting in a chair with both feet resting flat on floor 
and back straight and supported. After resting for at least 5 minutes with the left arm resting comfortably on a 
flat surface at heart level, the participants will be asked to turn on the BP machine which will be programmed to 
take 3 measurements at one-minute interval. Any participant with two readings of elevated BP (>130/80) will be 
referred to their PCP for management. Blood samples for glycated hemoglobin (HbA1c) and lipids (LDL, HDL, 
and total cholesterol) will be collected via fingerstick using HemaSpot SE kits which will be mailed to participants 
ahead of baseline assessment. The samples will be mailed to the lab for analysis using established protocols for 
dry blood spot method.  Type 2 diabetes risk score will be calculated using the ADA risk calculator with covariates 
that include; age, sex, family history of diabetes, history of hypertension, obesity, and PA.15 PA measures: Barriers 
to exercise self-efficacy will be assessed via BARSE scale,16 while ActiGraph GT9X will be used to assess 
participants’ PA patterns including steps, light PA and MVPA. These metrics will be calculated using Freedson 
adult VM3 cut points.18 For Aim 2, only the 7- day Actigraph data collected during baseline and 12-wks 
assessments will be used. Since PATH is expected to increase baseline MVPA by ≥60mins or 6000 steps at the 
end of the study, percent adherence will be calculated as: [(Post-intervention MVPA - Baseline MVPA) / MVPA 
goal] × 100 (e.g., [(140-90)/60] ×100 = 83% (The same formulae will be used for steps). Pre and post-intervention 
VO2 max will be calculated using the non-exercise prediction model for VO2 peak.2 described earlier. 
 
Data/Collection Tool 
Baseline 
3 months 
Screening Questionnaires 
 
 
Sociodemographic Questionnaire 
X 
 
Medical History Questionnaire 
X 
 
Physical Activity Readiness Questionnaire 
X 
 
American Diabetes Association Risk calculator 
X 
X 
Barriers Self-efficacy Scale 
X 
X 
Paffenbarger Exercise Habits Questionnaire 
X 
X 
PROMIS SF Sleep Disturbance Questionnaire 
X 
X 
PROMIS SF Sleep-Related Impairment Questionnaire 
X 
X 
Automated Self-Administered 24HR Dietary Recall 
X 
X 
Center for Epidemiologic Studies Depression Scale  
X 
X 
NIH Toolbox Perceived Stress 
X 
X 
Pittsburgh Fatigue Scale 
X 
X 
Physical activity index 
Modified Activity Questionnaire (MAQ) 
X 
X 
X 
X 
Cardiometabolic Assessments 
 
 
Zoom supervised self-administered Blood Pressure 
X 
X 
Zoom supervised self-administered Weight 
X 
X 
Zoom supervised self-administered waist circumference 
X 
X 
Height (self-reported) 
X 
 
Glycated hemoglobin (dry blood spot) 
X 
X 
Total cholesterol 
X 
X 
HDL cholesterol 
LDL cholesterol 
Predicted VO2 peak*   
X 
X 
X 
X 
X 
X 
Accelerometer data on sleep and physical activity 
X 
X 
Randomization via zoom 
X 
 
Intervention Satisfaction Questionnaire 
 
X 
Notes: *VO2 peak for men = 100.27-(0.296*age) -(0.369*waist circumference) - (0.155*resting heart rate)+(0.226*PA-
index**); * VO2 peak for women = 74.74-(0.247*age)-(0.259*waist circumference)-(0.114*resting heart rate)+(0.198*PA-index)