Active You: A Novel Exercise Program for African Americans

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04280783
• Other study ID #: STUDY19110217
• Secondary ID: 5UL1TR001857-04
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Primay Health Network	Beaver Falls	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Retained at the End of Study	Will be indicated by the number of enrolled participants who are retained by the end of the study.	Post-intervention at 12 weeks
Primary	Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period	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.	Post-intervention at 12 weeks
Primary	Acceptability of PATH Intervention	Percentage of participants who reported the PATH platform was culturally appropriate	Post-intervention at 12 weeks
Secondary	Body Mass Index (BMI) 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in Body Fat Percentage 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in Waist Circumference 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in Glycated Hemoglobin (HbA1C) 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	Post-intervention at 12 weeks
Secondary	Change From Baseline in Total Cholesterol 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in the Risk Score for Diabetes 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.	Post-intervention at 12 weeks
Secondary	Change From Baseline in Step Count 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	Post-intervention at 12 weeks
Secondary	Change From Baseline in Light Physical Activity at 12 Weeks	Light physical activity will be measured using a waist worn ActiGraph GT3X accelerometer	Post-intervention at 12 weeks
Secondary	Moderate to Vigorous Physical Activity	Change from baseline in moderate to vigorous physical activity (MVPA) at 12 weeks measured using a waist worn ActiGraph GT3X accelerometer	Post-intervention at 12 weeks
Secondary	Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale 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	Post-intervention at 12 weeks