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.

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.

The effectiveness of these programs for wheelchair users is hampered by the lack of a self-management strategy which most of the population takes for granted: a weight monitoring tool.

A crucial difference between the DPP-GLB and GLB-AIM trials is the weekly self-monitoring of weight as a form of accountability. In the DPP-GLB programs participants are weighed by the intervention coaches at the weekly meetings, which was not possible to do in the GLB-AIM as one disability-specific adaptation made to reduce transportation barriers to participation was that sessions were delivered telephonically most weeks, with participants only coming in once a month for an in-person session during which their weight would be obtained. But as most participants do not have accessible scales at home, they were unable to assess their weight weekly. Self-weighing frequency is associated with significantly greater weight loss, weight maintenance, and less body mass.

Evidence suggests that over a two-year period individuals who self-weigh daily will lose up to 18 lbs. more than those who do not self-weigh as frequently, and individuals who self-weigh more frequently are 60 to 80 percent more likely to maintain their weight. Unfortunately people with mobility impairments who are unable to stand or have balance issues do not have technology that is feasible for them to use to self-weigh frequently, which has been a noted limitation of weight loss interventions for this population.

Most wheelchair users do not have accessible scales at home and few primary health care providers have accessible scales to weight their patients who use wheelchairs. In fact, a recent survey of over 700 US physicians revealed that less than a quarter (22.6 percent) reported using an accessible scale to measure weight, while 72 percent relied on asking the patient to self-report their weight. Our colleague and co-investigator on this project, Dr. Froehlich-Grobe, reported that the average amount of time that had passed since wheelchair users in a previous trial had been weighed was 19.6+41.4 months, which suggests that most wheelchair users do not have an accurate estimate of their weight.

Although internet-enabled scales are available for in-home that range in price from 50 to 200 dollars, no equivalent technology exists for wheelchair users who cannot stand. Hospital and clinic-based scales such as roll-on, lift-based, and integrated bed scales are available for weight measurement but have little applicability in the home. Roll-on scales, for instance, are expensive, too large for most homes, and require the person to be weighed in their wheelchair and then transferred out of the wheelchair so that the wheelchair can be weighed separately, which makes self-weighing difficult without assistance. Lift-based scales are also large, expensive, and require assistance since the wheelchair user must be transferred onto the lift's platform for weighing. Hospital-based bed scales are convenient for the in-patient population but are not applicable for in-home use for several reasons: they cannot be integrated into a user's current bed; they do not accommodate weight measurement for multiple people (e.g. husband/wife); they are expensive; they do not provide the affordance of monitoring with mobile devices; and there is evidence that they are not accurate. Consequently, if wheelchair users want to monitor their weight, they often schedule a visit to the clinic or simply estimate their weight which is known to be inaccurate. The need for an easy-to-use home-based scale motivated us to develop the Fast In-Bed Tracking System (FIT).

The FIT will provide wheelchair users with an accurate, affordable, practical weight monitoring system. The investigators propose work to support refinements and translation of the FIT, which is a low-cost, easy-to-use scale that can be integrated into any bed which will automatically log weight for wheelchair users who use a bed without changes to their daily routine.

Inclusion Criteria:

• Age18 +
• Live within approximately 75 miles of Pittsburgh
• Uses a wheelchair as primary means of locomotion
• Currently transfers in and out of bed every night (or most nights)
• Has been diagnosed as obese or overweight
• Are interested in losing weight
• BMI in the range of approximately 25 to 40; BMI range will be determined from published evidence for the primary diagnosis of the participant. For example, spinal cord injury /quadriplegic BMI range of approximately 22 to 40; for amputees it will be based on location and level of amputation, or if no diagnosis specific evidence exists, a BMI of approximately 25 to 40 will be used as a general guideline.
• Own a smart phone, and have reliable internet and wifi connection
• Are comfortable using exercise equipment like resistance bands or hand pedal exercisers
• Are able and willing to engage in exercise of moderate intensity
• Weight in bed including sleep partner is an estimated combined weight of 600 pounds or less
• Does not have a regular way to weigh themselves, such as a roll-on scale in the home or gym, or have regular access to a device to weigh themselves regularly and are willing to avoid weighing themselves during the trial.
• Indication that the participant has autonomy in decision-making as determined by the "Everyday Autonomy Self-Determination Scale."
• Indication that their current bedroom setup is compatible with the FIT bed scales as determined by the "Bed Determination Survey."

Due to the medical complexity of this population, inclusion of this study based on BMI, in-bed transfer frequency, or geographic location will be at the discretion of the expert members of our study team and will be considered on a case-by-case basis.

Exclusion Criteria:

• Extended vacations or absences planned in the next year (more that 2 - 4 weeks) or plans to move approximately 75 miles or greater from the Pittsburgh region
• BMI outside of the desired range as based on condition and as determined by the study team.
• Currently taking weight loss medication, medications that affect appetite, or have had weight loss surgery in the last 2 years.
• History disordered eating in the last 2 years, such as Anorexia Nervosa, Bulimia Nervosa or Binge Eating Disorder
• Currently pregnant or intend to become pregnant in the next 12 months
• Regularly have 4 or more alcoholic drinks a day
• Have any cognitive conditions that limit decision making or self-governing.
• Indication that the participant does not have autonomy in decision-making as determined by the "Everyday Autonomy Self-Determination Scale."
• Indication that their current bedroom setup is not compatible with the FIT bed scales as determined by the "Bed Determination Survey."

Due to the medical complexity of this population, exclusion from this study based on BMI, geographic location, and what is considered a "medication that affects appetite" will be at the discretion of the expert members of our study team and will be considered on a case-by-case basis.

IPD will not be shared as a condition of IRB approval and individual experiences of the clinical trial will not be of clinical relevance to the field. Aggregate data will be released as to the efficacy of the device to be studied in the clinical trial.