Trial Outcomes & Findings for Active You: A Novel Exercise Program for African Americans (NCT NCT04280783)

NCT ID: NCT04280783

Last Updated: 2024-11-05

Results Overview

Will be indicated by the number of enrolled participants who are retained by the end of the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Post-intervention at 12 weeks
• Results posted on: 2024-11-05

Participant Flow

Participant milestones

Measure	PATH 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	PATH 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Overall Study Family issues unrelated to the study.	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Active You: A Novel Exercise Program for African Americans

Baseline characteristics by cohort

Measure	PATH Treatment Group n=15 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=15 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA into their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.	Total n=30 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 8.0 • n=5 Participants	55.9 years STANDARD_DEVIATION 8.5 • n=7 Participants	55.9 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Body Mass Index	38.29 Kg/M^2 STANDARD_DEVIATION 7.56 • n=5 Participants	37.08 Kg/M^2 STANDARD_DEVIATION 6.63 • n=7 Participants	37.69 Kg/M^2 STANDARD_DEVIATION 7.01 • n=5 Participants
Systolic Blood Pressure	120.33 mmHg STANDARD_DEVIATION 17.37 • n=5 Participants	124.07 mmHg STANDARD_DEVIATION 19.50 • n=7 Participants	122.20 mmHg STANDARD_DEVIATION 18.24 • n=5 Participants
Diastolic Blood Pressure	79.87 mmHg STANDARD_DEVIATION 10.11 • n=5 Participants	81.50 mmHg STANDARD_DEVIATION 10.66 • n=7 Participants	80.68 mmHg STANDARD_DEVIATION 10.24 • n=5 Participants
Objective weekly MVPA minutes	169.73 Minutes STANDARD_DEVIATION 159.86 • n=5 Participants	156.60 Minutes STANDARD_DEVIATION 127.53 • n=7 Participants	163.17 Minutes STANDARD_DEVIATION 142.25 • n=5 Participants
Adherence to MVPA guidelines at baseline	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Objective average daily steps	2923.6 Steps STANDARD_DEVIATION 2897.4 • n=5 Participants	1983.11 Steps STANDARD_DEVIATION 2418.76 • n=7 Participants	2910.5 Steps STANDARD_DEVIATION 2173.26 • n=5 Participants

PRIMARY outcome

Timeframe: Post-intervention at 12 weeks

Population: All participants enrolled in the study

Will be indicated by the number of enrolled participants who are retained by the end of the study.

Outcome measures

Measure	PATH Treatment Group n=15 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=15 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Percentage of Participants Retained at the End of Study	93.33 Percent of enrolled participants	93.33 Percent of enrolled participants

PRIMARY outcome

Timeframe: Post-intervention at 12 weeks

will be indicated by the proportion of the sample with ≥4days per week of valid Actigraph wear time (≥10hrs) during the entire course of the study.

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period	92.86 percentage of the sample	71.43 percentage of the sample

PRIMARY outcome

Timeframe: Post-intervention at 12 weeks

Percentage of participants who reported the PATH platform was culturally appropriate

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Acceptability of PATH Intervention	100 percentage of intervention participants	92.86 percentage of intervention participants

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

BMI will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their BMI and will supervise the measurement via HIPAA compliant Zoom session.

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Body Mass Index (BMI) at 12 Weeks	37.62 kg/m^2 Standard Deviation 7.85	36.65 kg/m^2 Standard Deviation 6.43

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Body fat percentage will be measured using Fitbit Aria II scale provided to the participant by the study team. The study team will guide the participants on how to measure their body fat and will supervise the measurement via HIPAA compliant Zoom session.

Outcome measures

Measure	PATH Treatment Group n=13 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Body Fat Percentage at 12 Weeks	-1.445 body fat percentage Standard Error .377	-.522 body fat percentage Standard Error .426

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Waist circumference will be measured using Perfect waist tape measure provided to the participant by the study team. The study team will guide the participants on how to take the measurement using a standard video and will be able to observe the outcome of the measurement via HIPAA compliant Zoom session.

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Waist Circumference at 12 Weeks	-.182 Inches Standard Error .793	-.948 Inches Standard Error .499

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Both diastolic and systolic BP will be reported. The measurement will be done using automated OMRON BP machine provided to the participant by the study team. The study team will guide the participants on how to take blood pressure and will supervise the measurement via HIPAA compliant Zoom session.

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks	-1.869 mmHg Standard Error 4.107	-3.899 mmHg Standard Error 3.744

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

The sample for HbA1C will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols

Outcome measures

Measure	PATH Treatment Group n=9 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=10 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks	.007 Percentage of glycated hemoglobin" Standard Error .118	.072 Percentage of glycated hemoglobin" Standard Error .112

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

The blood sample for lipids (total cholesterol) will be collected by participants at home using the dry blood spot method. The study team will guide the participants on how to take the sample using a standard video and will supervise the collection via HIPAA compliant Zoom session. The sample will be processed by CoreMedica lab using standard protocols.

Outcome measures

Measure	PATH Treatment Group n=10 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=9 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Total Cholesterol at 12 Weeks	10.623 mg/dL Standard Error 12.932	-13.363 mg/dL Standard Error 12.281

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Population: End of study ADA score data were not collected

The risk score for diabetes will be measured via the American Diabetes Association (ADA) Risk Calculator. The scores range from 0 to 10 with higher scores indicating high risk for developing type 2 diabetes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Step count will be measured using a wrist worn ActiGraph GT9X link during the entire study period. The study outcomes will focus on change from baseline to 12 weeks

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Step Count at 12 Weeks	618.633 Steps Standard Error 235.36	239.965 Steps Standard Error 401.713

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks measured using a waist worn ActiGraph GT3X accelerometer

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Moderate to Vigorous Physical Activity	33.498 Minutes Standard Error 22.025	18.582 Minutes Standard Error 26.221

SECONDARY outcome

Timeframe: Post-intervention at 12 weeks

Participants will be asked to respond to the BARSE scale appraising their exercise self-efficacy. The scale range from 0 to 100, with higher scores indicating increased exercise self-efficacy

Outcome measures

Measure	PATH Treatment Group n=14 Participants 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. The Physical Activity for The Heart (PATH) intervention: The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.	Wait-list Control Group n=14 Participants 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. Be Active Your Way Booklet: Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks	54.4 score on a scale Standard Deviation 6.5	56.9 score on a scale Standard Deviation 6.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention at 12 weeks

Light physical activity will be measured using a waist worn ActiGraph GT3X accelerometer

Outcome measures

Outcome data not reported

Adverse Events

PATH Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Kariuki

Emory University

Phone: 4047272353

Email: jacob.kariuki@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place