NCT04280783

Active You: A Novel Exercise Program for African Americans

Completed NA Results posted Last updated 5 November 2024

What this trial tests

NA trial testing The Physical Activity for The Heart (PATH) intervention in Cardiovascular Risk Factor in 30 participants. Completed in 31 December 2021.

Timeline

27 October 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	30
Start date	27 October 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	2 locations across United States

Drugs / interventions tested

• The Physical Activity for The Heart (PATH) intervention
• Be Active Your Way Booklet

Conditions studied

• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
• Prediabetes — all drugs for Prediabetes →
• Overweight and Obesity — all drugs for Overweight and Obesity →
• Sedentary Behavior — all drugs for Sedentary Behavior →

Sponsor

University of Pittsburgh

Who can join

Adults 40 to 70, any sex, with Cardiovascular Risk Factor or Prediabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Retained at the End of Study Primary · Post-intervention at 12 weeks

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

Group	Value	95% CI
PATH Treatment Group	93.33
Wait-list Control Group	93.33

Percentage of Participants Who Self-monitored Step Count Using Wrist Worn ActiGraph GT9X Over the Study Period Primary · 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.

Group	Value	95% CI
PATH Treatment Group	92.86
Wait-list Control Group	71.43

Acceptability of PATH Intervention Primary · Post-intervention at 12 weeks

Percentage of participants who reported the PATH platform was culturally appropriate

Group	Value	95% CI
PATH Treatment Group	100
Wait-list Control Group	92.86

Body Mass Index (BMI) at 12 Weeks Secondary · 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.

Group	Value	95% CI
PATH Treatment Group	37.62	± 7.85
Wait-list Control Group	36.65	± 6.43

Change From Baseline in Body Fat Percentage at 12 Weeks Secondary · 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.

Group	Value	95% CI
PATH Treatment Group	-1.445	± .377
Wait-list Control Group	-.522	± .426

Change From Baseline in Waist Circumference at 12 Weeks Secondary · 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.

Group	Value	95% CI
PATH Treatment Group	-.182	± .793
Wait-list Control Group	-.948	± .499

Change From Baseline in Systolic Blood Pressure (SBP) at 12 Weeks Secondary · 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.

Group	Value	95% CI
PATH Treatment Group	-1.869	± 4.107
Wait-list Control Group	-3.899	± 3.744

Change From Baseline in Glycated Hemoglobin (HbA1C) at 12 Weeks Secondary · 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

Group	Value	95% CI
PATH Treatment Group	.007	± .118
Wait-list Control Group	.072	± .112

Change From Baseline in Total Cholesterol at 12 Weeks Secondary · 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.

Group	Value	95% CI
PATH Treatment Group	10.623	± 12.932
Wait-list Control Group	-13.363	± 12.281

Change From Baseline in Step Count at 12 Weeks Secondary · 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

Group	Value	95% CI
PATH Treatment Group	618.633	± 235.36
Wait-list Control Group	239.965	± 401.713

Moderate to Vigorous Physical Activity Secondary · 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

Group	Value	95% CI
PATH Treatment Group	33.498	± 22.025
Wait-list Control Group	18.582	± 26.221

Change From Baseline in Barriers Exercise Self-efficacy (BARSE) Scale at 12 Weeks Secondary · 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

Group	Value	95% CI
PATH Treatment Group	54.4	± 6.5
Wait-list Control Group	56.9	± 6.4

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The 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: Protocol for a pilot randomized controlled trial.
   Kariuki JK, Gibbs BB, Erickson KI, Kriska A, et al · · 2021 · cited 5× · PMID 33798731 · DOI 10.1016/j.cct.2021.106380
2. Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial.
   Kariuki JK, Sereika S, Erickson K, Burke LE, et al · · 2023 · cited 4× · PMID 37625586 · DOI 10.1016/j.cct.2023.107318