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
2 other identifiers
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedResults Posted
Study results publicly available
December 4, 2023
CompletedNovember 5, 2024
October 1, 2024
1.2 years
February 19, 2020
July 21, 2023
October 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Acceptability of PATH Intervention
Percentage of participants who reported the PATH platform was culturally appropriate
Post-intervention at 12 weeks
Secondary Outcomes (10)
Body Mass Index (BMI) at 12 Weeks
Post-intervention at 12 weeks
Change From Baseline in Body Fat Percentage at 12 Weeks
Post-intervention at 12 weeks
Change From Baseline in Waist Circumference at 12 Weeks
Post-intervention at 12 weeks
Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks
Post-intervention at 12 weeks
Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks
Post-intervention at 12 weeks
- +5 more secondary outcomes
Other Outcomes (1)
Change From Baseline in Light Physical Activity at 12 Weeks
Post-intervention at 12 weeks
Study Arms (2)
PATH Treatment Group
EXPERIMENTALThe 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.
Wait-list control group
OTHERParticipants 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- years old
- BMI≥25
- Have regular access to the internet (via computer or smart phone)
- Less than 90 mins of self-reported moderate to vigorous physical activity per week
- American Diabetes Association (ADA) risk ≥5
- Available for pre and post-intervention assessments.
- Self-identify as Black/African American
You may not qualify if:
- Unstable conditions that may require supervised PA
- Physical limitations that may prohibit engagement in MVPA
- Pregnancy or intention to become pregnant during study, history of CVD
- Current participation in a PA study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Primay Health Network
Beaver Falls, Pennsylvania, 15010, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (1)
Kariuki JK, Sereika S, Erickson K, Burke LE, Kriska A, Cheng J, Milton H, Hirshfield S, Ogutu D, Gibbs B. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. Contemp Clin Trials. 2023 Oct;133:107318. doi: 10.1016/j.cct.2023.107318. Epub 2023 Aug 23.
PMID: 37625586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The short study length and small sample size limit our ability to test effectiveness; however, as our study was meant to demonstrate feasibility and acceptability, in line with the ORBIT model, this is appropriate for the formative phase of behavioral intervention development.
Results Point of Contact
- Title
- Dr. Jacob Kariuki
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Kariuki, PhD
University of Pittsburgh
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 21, 2020
Study Start
October 27, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
November 5, 2024
Results First Posted
December 4, 2023
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- 12 months after the end of the study
- Access Criteria
- Data access will be provided based on scientific merit of the proposed analysis, IRB approval and data agreement contract as deemed appropriate by University of Pittsburgh
It is our goal to make all data generated from this proposal available to other investigators without compromising the confidentiality of participants. Investigators who would like to do a secondary analysis of de-identified data can submit a formal request for the data including the proposal of their intended analysis to the PI at activeu@pitt.edu. The PI will review all requests and facilitate data access once approval is granted.