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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonathan Pearlman

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • The Fast In-Bed Tracking System (FIT) Weight Scale
  • Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) intervention

Treatment groups

92 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Jonathan Pearlman

Lead sponsor

University of Pittsburgh

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

NuRelm, Inc.

Collaborator

Craig Hospital

Collaborator