Active You: A Novel Exercise Program for African Americans
Condition: Cardiovascular Risk Factor; Prediabetes; Overweight and Obesity; Sedentary Behavior
MeSH terms: Overweight
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): The Physical Activity for The Heart (PATH) intervention; Be Active Your Way Booklet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We will randomize 30 participants to either the PATH treatment group or wait-list control group.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity; Web-based; YouTube; Remote