N/A
N=30
Active You: A Novel Exercise Program for African Americans
Cardiovascular Risk Factor · Prediabetes · Overweight and Obesity · Sedentary Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04280783 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Percentage of Participants Retained at the End of Study — 93.33; 93.33 Percent of enrolled participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Physical Activity for The Heart (PATH) intervention (Behavioral); Be Active Your Way Booklet (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Retained at the End of Study |
93.33; 93.33 | — |
| PRIMARY Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period |
92.86; 71.43 | — |
| PRIMARY Acceptability of PATH Intervention |
100; 92.86 | — |
| SECONDARY Body Mass Index (BMI) at 12 Weeks |
37.62; 36.65 | — |
| SECONDARY Change From Baseline in Body Fat Percentage at 12 Weeks |
-1.445; -.522 | — |
| SECONDARY Change From Baseline in Waist Circumference at 12 Weeks |
-.182; -.948 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks |
-1.869; -3.899 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks |
.007; .072 | — |
| SECONDARY Change From Baseline in Total Cholesterol at 12 Weeks |
10.623; -13.363 | — |
| SECONDARY Change From Baseline in the Risk Score for Diabetes at 12 Weeks |
— | — |
| SECONDARY Change From Baseline in Step Count at 12 Weeks |
618.633; 239.965 | — |
| SECONDARY Moderate to Vigorous Physical Activity |
33.498; 18.582 | — |
| SECONDARY Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks |
54.4; 56.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 40-70 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04280783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.