Active You: A Novel Exercise Program for African Americans

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease

NCT04621045

Cardiovascular Risk Factor Prediabetes Overweight and Obesity +1 more

COMPLETED NA

Active You: Walk, Dance, and Tone Your Abs to Reduce Your Risk of Diabetes

NCT06127251

Obesity

COMPLETED NA

Web-based Physical Activity Intervention to Promote Physical Activity

NCT05803304

Cardiovascular Diseases

COMPLETED NA

Mobile-based Online Social Network Intervention to Increase Physical Activity

NCT02736903

Sedentary Lifestyle

COMPLETED NA

An Intervention to Increase Physical Activity Among African American Women

NCT00473044

Sedentary Lifestyle Inactivity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Risk Factor Prediabetes Overweight and Obesity Sedentary Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

The Physical Activity for The Heart (PATH) intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Be Active Your Way Booklet

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes