Active You: A Novel Exercise Program for African Americans

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04280783

Enrollment

Registered

2020-02-21

Start date

2020-10-27

Completion date

2021-12-31

Last updated

2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor, Overweight and Obesity, Prediabetes, Sedentary Behavior

Keywords

Physical activity, Web-based, YouTube, Remote

Brief summary

Barriers to physical activity (PA) among African Americans (AAs) have been extensively studied, yet there is a paucity of innovative PA interventions designed to address them. In recent years, many studies have used the internet to promote PA in many settings, including the home environment, but only a few studies have recruited AAs. Without innovative and culturally relevant interventions, AAs will continue reporting extremely low levels of PA and disparate cardiovascular health outcomes. In prior work, the investigators sought the input of AA focus groups to inform the development of a technology-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. The investigators designed PATH as a culturally salient action-oriented intervention that can be accessed in any setting to promote PA among inactive AAs. In this application, the investigators propose to examine whether PATH is a feasible strategy for promoting PA among inactive AAs. In Aim 1 the investigators will conduct a randomized clinical trial that will include 30 inactive AAs to assess the feasibility and acceptability of the PATH intervention. In Aim 2 the investigators will examine the trend in PA and cardiovascular disease risk change from baseline to post-intervention. This approach is innovative because it leverages openly accessible technologies to provide a wide variety of free, enjoyable and action-oriented workout videos that match AAs preferences. This contribution will be significant because PATH could offer a novel, low-cost, and scalable strategy for promoting PA among individuals facing socio-environmental barriers to PA.

Detailed description

Whereas an inverse dose-response relationship has been established between physical activity (PA) and a host of chronic illnesses, including cardiovascular disease (CVD), most American adults (79%) are physically inactive and do not attain the minimum PA levels recommended by the PA Guidelines for Americans. African Americans (AAs) in particular report very low levels of PA, and have the highest burden of CVD in the United States.To eliminate the prevailing cardiovascular health disparities, there is a critical need for pragmatic and culturally salient interventions that are designed to address barriers to PA that are more problematic for AAs. Common barriers to PA such as lack of time and low exercise self-efficacy are pervasive in all racial groups. In addition to these barriers, socio-environmental factors, such as unsafe neighborhoods and limited access to fitness facilities play a key role in perpetuating the low levels of PA observed in AAs. To mitigate these barriers, home-based PA interventions delivered via mail, telephone and internet have been developed. Although only a few of these interventions have been tested among AAs, preliminary studies have reported more participation and retention of AAs in home-based PA programs. However, the associated PA outcomes have been minimal, especially in less educated AAs. Low literacy levels and reliance on print-based resources with no cultural appeal are thought to limit the utility of the interventions in AAs. The investigators have previously reported how AAs prefer PA programs that are visual, convenient, fun to engage in, and feature people they can relate to especially in body size, fitness status and age. Other studies have reported similar preferences for PA among AAs, yet there is a paucity of PA interventions that are designed to incorporate these preferences. To bridge this gap, the investigators have developed a web-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the reported preferences. Currently, PATH includes 90 workout videos vetted using the FITT principle (frequency, intensity, time, type) 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. The overarching aim of the proposed study is to conduct a pilot randomized controlled trial (RCT) to assess the feasibility and acceptability of the PATH intervention for promoting PA in AAs. The investigators will enroll 30 inactive AAs and randomize them to either treatment (12-wks of PATH) or wait-list control (use a general health handout) group to address the following specific aims: Aim 1: Assess the feasibility and acceptability of the PATH intervention among inactive AAs. Feasibility will be assessed via 1) number of participants screened for eligibility; 2) percentage eligible; 3) percentage enrolled; 4) percentage retained within each randomized group; and 5) adherence to self-monitoring (Actigraph wear time) and intervention protocol (PATH utilization). Acceptability will be evaluated via a post-intervention survey developed by the study team to appraise the intervention's usability and perceived efficacy for increasing PA. Aim 2: Describe the trends in PA and CVD risk change from baseline to post-intervention. The primary outcome will be PA and will include objectively measured steps, light PA, and moderate-to-vigorous PA (MVPA). Cardiovascular outcomes will include blood pressure (BP), body fat percentage, body mass index (BMI), glycated hemoglobin (HbA1c) and lipids (LDL, HDL, and total cholesterol). Trends will be summarized as mean within-group changes (with 95% confidence intervals \[CIs\]). The proposed research addresses a key driver of cardiovascular health disparities and is innovative in its rigorous testing of the novel PATH intervention for feasibility and acceptability among inactive AAs. Findings from this study will inform the refinement of the PATH intervention to be tested in a full-scale RCT.

Interventions

BEHAVIORALThe 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.

BEHAVIORALBe 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

We will randomize 30 participants to either the PATH treatment group or wait-list control group.

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. 40-70 years old 2. BMI≥25 3. Have regular access to the internet (via computer or smart phone) 4. Less than 90 mins of self-reported moderate to vigorous physical activity per week 5. American Diabetes Association (ADA) risk ≥5 6. Available for pre and post-intervention assessments. 7. Self-identify as Black/African American

Exclusion criteria

1. Unstable conditions that may require supervised PA 2. Physical limitations that may prohibit engagement in MVPA 3. Pregnancy or intention to become pregnant during study, history of CVD 4. Current participation in a PA study.

Design outcomes

Primary

Measure	Time frame	Description
Acceptability of PATH Intervention	Post-intervention at 12 weeks	Percentage of participants who reported the PATH platform was culturally appropriate
Percentage of Participants Retained at the End of Study	Post-intervention at 12 weeks	Will be indicated by the number of enrolled participants who are retained by the end of the study.
Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Waist Circumference at 12 Weeks	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.
Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks	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.
Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks	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
Change From Baseline in Total Cholesterol at 12 Weeks	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.
Change From Baseline in Step Count at 12 Weeks	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
Moderate to Vigorous Physical Activity	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
Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks	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
Change From Baseline in the Risk Score for Diabetes at 12 Weeks	Post-intervention at 12 weeks	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.
Body Mass Index (BMI) at 12 Weeks	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.
Change From Baseline in Body Fat Percentage at 12 Weeks	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.

Other

Measure	Time frame	Description
Change From Baseline in Light Physical Activity at 12 Weeks	Post-intervention at 12 weeks	Light physical activity will be measured using a waist worn ActiGraph GT3X accelerometer

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	15
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 into their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.	15
Total	30

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Family issues unrelated to the study.	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Total	Wait-list Control Group	PATH Treatment Group
Adherence to MVPA guidelines at baseline	10 participants	5 participants	5 participants
Age, Continuous	55.9 years STANDARD_DEVIATION 8.2	55.9 years STANDARD_DEVIATION 8.5	55.9 years STANDARD_DEVIATION 8
Body Mass Index	37.69 Kg/M^2 STANDARD_DEVIATION 7.01	37.08 Kg/M^2 STANDARD_DEVIATION 6.63	38.29 Kg/M^2 STANDARD_DEVIATION 7.56
Diastolic Blood Pressure	80.68 mmHg STANDARD_DEVIATION 10.24	81.50 mmHg STANDARD_DEVIATION 10.66	79.87 mmHg STANDARD_DEVIATION 10.11
Objective average daily steps	2910.5 Steps STANDARD_DEVIATION 2173.26	1983.11 Steps STANDARD_DEVIATION 2418.76	2923.6 Steps STANDARD_DEVIATION 2897.4
Objective weekly MVPA minutes	163.17 Minutes STANDARD_DEVIATION 142.25	156.60 Minutes STANDARD_DEVIATION 127.53	169.73 Minutes STANDARD_DEVIATION 159.86
Race/Ethnicity, Customized Black	30 Participants	15 Participants	15 Participants
Region of Enrollment United States	30 Participants	15 Participants	15 Participants
Sex: Female, Male Female	26 Participants	13 Participants	13 Participants
Sex: Female, Male Male	4 Participants	2 Participants	2 Participants
Systolic Blood Pressure	122.20 mmHg STANDARD_DEVIATION 18.24	124.07 mmHg STANDARD_DEVIATION 19.5	120.33 mmHg STANDARD_DEVIATION 17.37

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15
other Total, other adverse events	0 / 15	0 / 15
serious Total, serious adverse events	0 / 15	0 / 15