Status:
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.
Lead Sponsor:
Jonathan Pearlman
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NuRelm, Inc.
Conditions:
Disability Physical
Wheelchair
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Wheelchair users and people with mobility impairments face increased risks of many chronic diseases including hypertension, diabetes, cardiovascular disease, and obesity. Physical inactivity of wheelc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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."
- Due to the medical complexity of this population, exclusion from this study based on BMI, geographic location, and what is considered a "medication that affects appetite" will be at the discretion of the expert members of our study team and will be considered on a case-by-case basis.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT07141342
Start Date
October 1 2025
End Date
September 1 2027
Last Update
September 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology
Pittsburgh, Pennsylvania, United States, 15206