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

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.

• Participant's Adherence to the Diet and Exercise Intervention (Average Days Per Week of Food Tracking) [Time frame: Baseline to Month 12]
• Participant's Average Daily Caloric Intake when Tracking Food [Time frame: Baseline to Month 12]
• Changes in Participant's Body Composition [Time frame: Baseline, Month 6, Month 12]
• Changes in Participant's Dietary Intake [Time frame: Baseline, 6 and 12 months]
• Average weekly minutes of physical activity (strength, aerobic) [Time frame: Baseline to Month 12]
• Usability and acceptability of the Fast In-Bed Tracking (FIT) bed scale [Time frame: Months 1, 6 and 12]
• Changes in Participant's Sleep Duration and Quality [Time frame: Baseline, 6 and 12 months]
• Changes in Participant's Self-Efficacy in Health Practices [Time frame: Baseline, 6 and 12 months]