Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a Clinical Trial of a Bed Scale Device. Overweight Wheelchair Users Will Complete a Weight Loss Program, Half Get Scales at Baseline, Half at Month 6 Those Who Receive the Bed Scales at Baseline Are Expected to Have Increased Weight Loss
brief summary
This project will complete the final design and development steps to commercialize the Fast In-Bed Tracking (FIT) Platform, which is an e-Health and wellness Internet of Things (IoT) monitoring system that can be integrated into a user's bed and provide person-centered, real-world outcomes to support health and wellness. The technical feasibility of FIT was proven over the past several years and has demonstrated the platform can support the treatment of several chronic conditions across different populations, including obesity, congestive heart failure, and pressure injuries. The project goals will be to (1) complete design refinements for FIT and (2) demonstrate the platform's efficacy to support weight loss goals of wheelchair users. Wheelchair users are twice as likely as the general population to be overweight or obese and excess weight not only exacerbates mobility and participation limitations but increases risk for secondary health problems. Evidence reveals that frequent weight monitoring is a key driver for weight management, which puts wheelchair users at a significant disadvantage, because they have no convenient way to measure their body weight. As a recent example, lack of participant's ability to self-weigh was a noted limitation to a weight loss program for wheelchair users, known as the Group Lifestyle Balance weight loss program Adapted for Individuals with Impaired Mobility (GLB-AIM). FIT solves this challenge by passively monitoring a user's weight when they get on and off their bed. The investigators lab and community-based feasibility trials demonstrated that FIT successfully tracks weight for individuals and couples sharing a bed and that users find FIT highly usable. This proposed project will allow the investigators to complete the design refinements participants recommended during our community-based feasibility trial and subsequently examine the efficacy of FIT in supporting the weight-loss goals of community-dwelling wheelchair users through a randomized controlled trial using the GLB-AIM.
detailed description
Wheelchair users and people with mobility impairments face increased risks of many chronic diseases including hypertension, diabetes, cardiovascular disease, and obesity. Physical inactivity of wheelchair users is related to cardiovascular disease, high blood pressure, diabetes, osteoarthritis, osteoporosis, pressure ulcers, urinary tract infections, and repetitive strain injuries in upper extremities. These health problems cause a downward spiral and are major causes of mortality and morbidity in people with disabilities. This evidence indicates that a physically active lifestyle and healthy weight are critical for people with disabilities, especially wheelchair users, to avoid obesity-related health risks and enjoy a better quality of life.
The World Health Organization (WHO) indicates that worldwide obesity has nearly tripled since 1975. United States data from 2017 to 2020 reveal that 41.9 percent of American adults are obese and estimates indicate that obesity accounts for 173 billion dollars in annual healthcare costs. The distribution of body mass index (BMI) in the country shows 68.8 percent of adults older than 20 years are either overweight or obese.
Wheelchair users have significantly increased risk of obesity and obesity-related health consequences compared to the general population. For instance, Weil et al. found people with lower extremity disabilities to be two and a half times more likely to be obese than the general population. Unfortunately, very little research has been focused on addressing obesity issues for people with disabilities despite the substantial health consequences and costs.
Froehlich-Grobe (co-I on this project) and Lollar state that that "people with disabilities should be an emerging population of concern within public health efforts related to obesity. The three core public health functions of assessment, policy development, and assurance are used as a framework to address this serious public health threat for this group." As part of the policy development section, the authors further state that "research should examine environmental and contextual factors related to physical activity, nutritional intake, and weight maintenance among people with disabilities."
Lifestyle intervention programs exist which address these risks and specific barriers faced by wheelchair users. For individuals with mobility impairments, a host of complex issues make maintaining a healthy weight difficult. Physical barriers to exercise and physical activities, attitudinal barriers towards disability and health, environmental barriers for participation, and challenges with weight monitoring are some of the issues cited by the research community. Further, researchers have noted that individuals with impaired mobility face disability-related challenges that may reduce engagement in programs and interventions. Barriers include transportation and access to travel, caregiver availability to support program engagement, and health-related issues that may prohibit an individual from leaving the home or healthcare setting. These challenges motivated co-I Froehlich-Grobe and colleagues to develop the Group Lifestyle Balance Adapted for Individuals with Impaired Mobility, known as the GLB-AIM. The GLB-AIM is a direct adaptation of the Diabetes Prevention Program (DPP) - Group Lifestyle Balance (DPP-GLB) which has successfully yielded an average 6 percent weight loss at 12 months and reduced diabetes risk over 2.8 years by 58 percent, which was 39 percent lower than participants randomized to the metformin group. The GLB-AIM which has been proven feasible and effective in a pilot study and a randomized control trial (RCT) with 67 mobility impaired individuals randomized to the intervention group or a waitlist control group. There were significant between group differences in weight loss at 6 months (-1.7 kg loss vs 0.05 kg gain, p \<0.05) and combined results from both groups after receiving the intervention revealed an average weight loss at 12 months of 3.3 percent of their starting weight. Notably, the average loss was lower than the 5 to 7 percent achieved by diverse participants in the DPP-GLB trials.
official title
The Fast In-Bed Tracking (FIT) System Lifestyle Intervention