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MobileMen Project Protocol

MobileMen Project Protocol

African American men are at higher risk for serious health conditions such as cardiovascular disease, diabetes, and stroke compared to non-Hispanic White men. Physical activity is a modifiable health behavior that has been shown to decrease chronic disease risk. Still, engagement in physical activity is alarmingly low in African American men. While interventions to improve physical activity engagement are effective in several populations, very few have been tailored to the unique needs of African American men. Even fewer have leveraged mobile health apps, despite African American men’s interest in and willingness to use such technologies for health improvement.

Now a multi-disciplinary research team from Klein Buendel, Pennington Biomedical Research Center, and three universities is conducting a comparative effectiveness trial that aims to evaluate MobileMen, a physical activity promotion app tailored to the needs and preferences of African American men. The team has published the plans and methods for the trial in JMIR Research Protocols.

The trial compares the MobileMen app to a commercially available physical activity promotion app with similar features but without culturally tailored components. Specifically, the study is recruiting a sample of 100 “low active” (less than 7500 steps per day) African American men aged 30 years or older from Baton Rouge, Louisiana and its surrounding communities. All participants are given a Fitbit Charge 6 wearable activity tracker to assess daily physical and steps. Participants are randomly assigned to either the MobileMen intervention app or a comparator app. The intervention period is six months, during which participants will interact with their assigned mobile app.

MobileMen includes features such as digital badges earned for physical activity, tangible prizes like exercise equipment, challenges among participants, goal setting, nutrition, physical activity, and behavior change educational information in text, audio, and video formats.

Participants complete assessments at baseline and at six months after random assignment. Assessments include objective measurements of daily steps and minutes of moderate to vigorous physical activity, quality of life, dietary measures, self-efficacy for fruit and vegetable consumption and physical activity, and autonomous motivation for physical activity. Detailed descriptions of measures and methods can be found in the JMIR Research Protocols paper.

Mobile apps are a widely accessible means to disseminate culturally tailored physical activity promotion interventions to various populations, including African American men. MobileMen has the potential to impact physical engagement in African American men, to help improve the overall health and chronic disease risk in this underrepresented population.

This research is funded by an STTR Fast Track grant to Klein Buendel from the National Institute on Minority Health and Health Disparities (MD014947). The Principal Investigator is Dr. Robert Newton from the Pennington Biomedical Research Center. Authors on this paper include Callie Hebert, Phillip Nauta, and Dr. Robert Newton from the Pennington Biomedical Research Center; Dr. April Stull from Baylor University; Dr. Damon Swift from the University of Virginia; Dr. Derek Griffith from the University of Pennsylvania; and Dr. Kayla Nuss, Amanda Brice, and Dr. David Buller from Klein Buendel. The MobileMen app was programmed by the Klein Buendel Creative Team.

Design of a high-resistance inspiratory muscle strength training app

Design of a high-resistance inspiratory muscle strength training app

Dr. Kayla Nuss, Klein Buendel Scientist, and a collaborative research team from Klein Buendel and the University of Colorado Boulder have published a paper on the feasibility and design of a novel smartphone app to deliver blood pressure-lowering high-resistance inspiratory muscle strength training in the journal mHealth.

High-resistance inspiratory muscle strength training (IMST) is a time-efficient form of respiratory exercise shown to lower blood pressure in midlife and older adults (aged ≥50 years) in randomized controlled trials delivered in clinical research settings. The purpose of this study was to design a feasible and acceptable smartphone application (app) for independently delivering IMST for lowering blood pressure.

Two rounds of iterative focus groups comprised of midlife and older women and men with above-normal systolic blood pressure (self-reported ≥120 mmHg) were performed to gain feedback on interest in an IMST smartphone app and design features. Focus group results were analyzed using a Consensual Qualitative Research (CQR) coding and data analysis protocol. Clickable wireframes were developed based on focus group findings. The wireframes were then beta tested for usability and additional feedback from target users was obtained.

Among midlife and older adults, there was considerable interest in app-delivered IMST as a
lifestyle intervention for lowering blood pressure. Potential facilitators and barriers of use for a potential app also were uncovered. Furthermore, the app wireframes were found to be highly usable, indicating that the app is ready for full-scale programming. Detailed research methods, analyses, and results of this research are reported in the mHealth paper. In conclusion, the authors report that they have designed a feasible and acceptable smartphone app for independently delivering blood pressure-lowering IMST in midlife and older adults.

The research is supported by an STTR grant to Klein Buendel from the National Heart, Lung, and Blood Institute (HL167375; Dr. Douglas Seals, Principal Investigator, from the University of Colorado Boulder). The authors are Dr. Kayla Nuss, Amanda Brice, and Steven Fullmer from Klein Buendel; and Elizabeth Jones, CeAnn Udovich, Dr. Kaitlin Freeberg, Narissa McCarty, Dr. Douglas Seals, and Dr. Daniel Craighead from the Department of Integrative Physiology at University of Colorado Boulder.

Collaborator Spotlight:
Dr. Douglas Seals and Dr. Daniel Craighead

Collaborator Spotlight:
Dr. Douglas Seals and Dr. Daniel Craighead

Two accomplished integrative physiology scientists from the University of Colorado Boulder are launching a new research project in collaboration with Dr. Kayla Nuss and the Creative Team from Klein Buendel. The project will design and assess the feasibility of the using a smartphone app to help deliver a high-resistance inspiratory muscle strength training (IMST) program for improving blood pressure and reducing cardiovascular disease risk in midlife and older adults.

Douglas Seals, PhD, is a Distinguished Professor of Integrative Physiology (Boulder Campus) and Medicine (Anschutz Medical Campus) at the University of Colorado. He is also the Director of the Integrative Physiology of Aging Laboratory. He earned his doctoral degree in Applied Exercise Physiology from the University of Wisconsin in 1981. In his 35+ years of academics and research, Dr. Seals has become an expert on lifestyle and/or pharmacological interventions to improve cardiovascular function. His areas of research interest include cardiovascular aging, such as changes in systolic blood pressure, large artery stiffness, and vascular endothelial function; biological and lifestyle factors that influence cardiovascular aging; the integrative (molecular to systemic) mechanisms that mediate cardiovascular aging and its modulation by biological and lifestyle factors; and interventions to improve adverse physiological changes with aging, including cardiovascular dysfunction, reductions in motor performance, and impairments in cognitive function. His research has been continuously funded by research grants from the National Institutes of Health, particularly the National Institute on Aging, since 1986. Dr. Seals founded an NIH Clinical Translational Research Center at the University of Colorado Boulder in 1999 as a core facility for conducting biomedical research on human subjects. It was in this lab that Dr. Seals and Dr. Daniel Craighead (see below) established the efficacy of IMST for lowering blood pressure in a traditional clinical research setting. In 2004, Dr. Seals received a 10-year MERIT Award from the National Institute on Aging to support his research on cardiovascular aging. In 2008, he was named a Professor of Distinction in the College of Arts and Sciences at the University of Colorado Boulder. In 2013, he was named an Edward F. Adolph Distinguished Lecturer by the American Physiological Society for his work in the physiology of aging.

Daniel Craighead, PhD, is an Assistant Research Professor in the Department of Integrative Physiology at the University of Colorado Boulder. He earned his doctoral degree in Kinesiology from Penn State University in 2017, and completed a post-doctoral fellowship in the Integrative Physiology of Aging Laboratory at the University of Colorado Boulder in 2020. Dr. Craighead is a specialist in the study of IMST for lowering blood pressure. Dr. Craighead conducted the initial R21-supported clinical trial on IMST, upon which the new research project with Klein Buendel is based. The Small Business Technology Transfer (STTR) Phase I study is supported by the National Heart, Lung, and Blood Institute, and will design and assess the feasibility of a smartphone app for delivering an IMST program and improving blood pressure in midlife and older adults. The program will provide instruction and promote adherence to the IMST intervention. Ultimately, the app will provide for widespread dissemination and adoption of an innovative tool to easily lower blood pressure and reduce cardiovascular disease risk. Dr. Craighead also has been the Principal Investigator on a study assessing the efficacy of nicotinamide riboside, a dietary supplement, for lowering blood pressure and improving vascular function in older adults, among other research projects.

IMST for Reducing High Blood Pressure

IMST for Reducing High Blood Pressure

Midlife and older adults exhibit a rapid increase in systolic blood pressure (SBP) which is associated with an increased risk for cardiovascular diseases. Researchers at the University of Colorado Boulder recently established the clinical efficacy of high-resistance inspiratory muscle strength training (IMST), a novel form of physical training with minimal barriers to adherence, for lowering SBP in midlife and older adults in a clinical trial with regular clinic-based, researcher-supervised training.

A new Phase I STTR project seeks to leverage the growing field of digital health technologies by taking the first steps in developing a feasible and acceptable smartphone app that independently guides users through a high-resistance IMST program, a key step to translate IMST for widespread use and improving public health.

The research grant has been awarded to Klein Buendel and will be led by experts in cardiovascular health, aging and high-resistance IMST from the University of Colorado Boulder (Dr. Douglas Seals, Principal Investigator; Dr. Daniel Craighead, Co-Investigator) and digital health technology development and delivery from Klein Buendel (Dr. Kayla Nuss, Co-Investigator). The one-year project will collect feedback and preferences from potential users to guide app development and demonstrate feasibility of such a mobile app.

Specific Aims

Aim 1: Perform iterative focus groups in midlife/older adults with above-normal SBP to collect potential-user information to identify needs and preferences for effective IMST app design.

Aim 2: Design the conceptual model and develop planned app components, including printed wireframes, storyboards, and clickable wireframes.

Aim 3: Conduct beta and usability testing on the clickable wireframes to show feasibility, acceptability, and potential for engagement, and finalize IMST app design.

Successful completion of this Phase I study will provide evidence to support programming and evaluating the full-scale IMST app in a subsequent Phase II project. If awarded, the Phase II project would directly compare the efficacy of at-home, self-guided IMST with the app vs. home BP monitoring alone (usual care control) for lowering SBP in a randomized clinical trial. The ultimate research goal of Phases I and II is to produce a commercially-ready mobile app for at-home implementation of high-resistance IMST, as a cost-effective lifestyle intervention for lowering SBP, decreasing disease risk, and reducing health care costs.

The research is supported by a grant from the National Heart, Lung, and Blood Institute at the National Institutes of Health (HL167375; Dr. Douglas Seals, Principal Investigator).