RECRUITING

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.

Description

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.

Study Overview

Study Details

Study overview

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.

The Fast In-Bed Tracking (FIT) System Lifestyle Intervention

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.

Condition
Disability Physical
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology, Pittsburgh, Pennsylvania, United States, 15206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age18 +
  • * Live within 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 25 to 40
  • * 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.
  • * 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."
  • * Extended vacations or absences planned in the next year (more that 2 - 4 weeks) or plans to move 75 miles or greater from the Pittsburgh region
  • * BMI \<25 or \>40
  • * Currently taking weight loss medication 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."

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jonathan Pearlman,

Jonathan Pearlman, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Katherine Froehlich-Grobe, PhD, STUDY_DIRECTOR, Craig Hospital

Study Record Dates

2027-09