RecruitingNot Applicable

Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a Clinical Trial of a Bed Scale Device. Overweight Wheelchair Users Will Participate in a Weight Loss Program, Half Will Receive Bed Scales, and Participants Who Receive the Bed Scales Are Expected to Have Increased Weight Loss.

United States92 participantsStarted 2026-02-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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." Du…

What they're measuring

Weight Loss after 6 and 12 months comparing the intervention group (FIT bed scale with daily weight feedback) versus control group (weighed at baseline, 6 and 12 months)

Timeframe: Baseline, Month 6, Month 12

Trial details

NCT IDNCT07141342

SponsorJonathan Pearlman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Daniel Rusnak, MS

412-624-8575 dar27@pitt.edu