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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology
RECRUITING
Pittsburgh
Contact Information
Primary
Daniel Rusnak, MS
dar27@pitt.edu
412-624-8575
Backup
Jonathan Pearlman, PhD
jpearlman@pitt.edu
412-383-3955
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-09
Participants
Target number of participants: 92
Treatments
Active_comparator: GLB-AIM
All participants in the control group will receive the Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) intervention. The investigators anticipate a total of 46 participants will be randomized to the control group.~THE GLB-AIM is a 12-month intervention with a total of 23 sessions: 13 weekly core sessions to start the program, followed by 3 bi-weekly support sessions, and reducing to 1 monthly support session for the final 7 months.~Control participants will be asked to download the My Net Diary app onto their personal phone and to log daily food intake and exercise using the app for the first 13 weeks of the GLB-AIM program.~All subjects in the study will be enrolled in the GLB-AIM intervention; the only difference between the experimental and control group is that the control group will not receive the Fast In Bed Tracking System (FIT) scale during the study and therefore will not have the ability to self-monitor their weight.
Experimental: GLB-AIM + FIT Weight Scales
All participants in the experimental group will receive the Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) intervention and will be asked to download the My Net Diary app. The investigators anticipate a total of 46 participants will be randomized to the experimental group.~Participants who are randomized to the FIT Weight Scale Group will have the FIT scale set up in-home during the baseline visit by research team members. Intervention participants will be oriented to their scale if randomized into the FIT scale group.~Participants will be asked to enter their weight daily into the My Net Diary app.
Related Therapeutic Areas
Sponsors
Leads: Jonathan Pearlman
Collaborators: NuRelm, Inc., Craig Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov