Obesity Clinical Trial
Official title:
A Comparison of Video Conferencing and In-person Health Coaching Approaches in Combination With mHealth Devices on Weight Loss, Physical Activity, and Glycemic Control
The purpose of this study was to determine how 12 weeks of health coaching with individualized feedback and education in combination with mobile health devices (a digital wireless body weight scale and wireless activity tracker) influences body weight, waist circumference, physical activity levels, and select blood-borne markers of health (fasting blood glucose, hemoglobin A1c, and insulin). The individualized health coaching, education, and feedback was delivered by either video conferencing or direct, in-person consultation. All education materials including (i.e. video modules, exercise manuals, nutrition manuals) were designed and compiled by a team of health professionals from (inHealth Medical Services, Inc.). These materials focused on incorporating behavioral principles of self-monitoring, exercise, nutrition, goal setting, and behavior modification. Each participant was randomly assigned into one of two intervention groups (a video conferencing or in-person group) or a control group.
Telemedicine can be defined as using communication technologies, specifically video
conferencing, to support long-distance delivery of clinical health care and patient and
professional health-related education. Video conferencing (VC) has been used since the early
1990's as a tool to monitor symptoms (Hubble et al. 1992), and it has also been used in
various subspecialties such as heart disease (Winters & Winters, 2007), diabetes
prevention/management (Davis et al. 2010), mental health care (O'Reilly et al. 2007), and for
providing nutritional advice (Rollo et al. 2015). Evidence regarding the effectiveness of
video conferencing is amassing with systematic reviews revealing promising results in the
management of various chronic diseases (Pronk et al. 2011). However, to date there are no
published studies investigating a fully online, medically monitored, weight loss program
utilizing VC.
The application of VC has the potential to shift current clinical practice for medical weight
management/weight loss from traditional in-person medical office visits to remote delivery
using VC. eClinicalWorks® (ECW)l) is a telemedicine service company providing cost effective
medical care solutions to patients through the use of technology.ECW® provides patients with
an easy-to-use application that enables face-to-face contact with a healthcare provider
through the use of VC on their smart device from any location. The ECW® application which
will be utilized in the present study will be fully customized to utilize Bluetooth
connectivity to sync with commercially available clinical assessment tools such as body
weight scales and physical activity trackers to monitor obesity related health outcomes.
Through the integration of tools into a customized smartphone application provided by ECW®,
health care professionals in the present study will be able to evaluate a participant's body
weight, body composition, and physical activity through one convenient smartphone
application.
Within the obesity prevention and management strategies, the use of health coaching is one
possible way to improve patient lifestyle behavior change. Health coaching can be defined as
the "practice of providing health education within a coaching context to enhance the
knowledge of individuals which helps facilitate the achievement in their health-related
goals'' (Olson and Nesbitt et al. 2010). A fairly recent study (Ferrante et al. 2009) in
which more than 500 physicians were surveyed on their practices and management strategies
regarding extreme obesity (BMI ≥40kg/m2) indicated that having a readily available nutrition
and exercise therapist would be helpful in improving the quality of care in these patients,
thereby highlighting the benefits gained by using health coaches. The majority of health
coaching intervention studies investigating behavior change have been personalized and
conveyed to the individual participant through several mediums including telephone, (Huber et
al. 2015), web-based chatting (Hersey et al. 2012, Bennett et al. 2010), or a combination of
in-person and web-based delivery (Appel et al. 2011; Bennett et al. 2005). Additionally,
there appears to be great variability between interventions in the type of health care
professional utilized as health coaches including: nurses, health counselors, registered
dietitians, primary care providers, or diabetes educators (Kivela et al. 2014). However,
using a health coaching approach in which a multi-disciplinary team (medical doctor,
registered dietitian, and exercise physiologist) is utilized, as in the present study, has
yet to be examined. This is especially important as recent evidence has shown that increased
collaboration between healthcare professionals may enhance patient adherence, education, and
medical monitoring (Jeon & Park, 2015).
In addition to the utilization of both health coaching and VC, health professionals are
always seeking ways to objectively monitor and improve their patients' health and fitness,
especially between patient visits. A potential way health professionals can monitor a
patient's health metrics is through mobile health (mHealth) devices including smartphones and
wearable fitness trackers, as well as wireless weight scales, blood pressure cuffs, and
glucometers (Shaw et al. 2016). However, to leverage mHealth devices as tools to promote
patient self-monitoring, the integrated use of mHealth devices which collect, display, and
secure data through a unified system is needed. To date, only one study (Shaw et al. 2016)
examined the feasibility of multiple mHealth devices which transmitted data to a secure US
Food and Drug Administration (FDA) database. Therefore, The primary aim of this study was to
assess changes in physical activity, body weight and metabolic markers (fasting blood
glucose, insulin, insulin resistance, and hemoglobin A1c) in obese adults randomized into
either a control group or one of two intervention groups (an in-person group or VC group).
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