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RECRUITING

NCT07141342

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.

Sponsor: Jonathan Pearlman

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-16

Completion Date

2027-09

Last Updated

2026-02-23

Healthy Volunteers

Conditions

Disability Physical Wheelchair Obesity; Overweight

Interventions

DEVICE

The Fast In-Bed Tracking System (FIT) Weight Scale

It is hypothesized that wheelchair users who are randomized into the FIT Weight Scales group will lose a significantly greater percent of body weight over time (6 months, 12 months) than wheelchair users randomized to the control group.

BEHAVIORAL

Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) intervention

The GLB-AIM is a direct adaptation of the Diabetes Prevention Program (DPP) - Group Lifestyle Balance (DPP-GLB) which has successfully yielded an average 6 percent weight loss at 12 months and reduced diabetes risk over 2.8 years by 58 percent, which was 39 percent lower than participants randomized to the metformin group. The GLB-AIM which has been proven feasible and effective in a pilot study and a randomized control trial (RCT) with 67 mobility impaired individuals randomized to the intervention group or a waitlist control group. There were significant between group differences in weight loss at 6 months (-1.7 kg loss vs 0.05 kg gain, p \<0.05) and combined results from both groups after receiving the intervention revealed an average weight loss at 12 months of 3.3 percent of their starting weight. Notably, the average loss was lower than the 5 to 7 percent achieved by diverse participants in the DPP-GLB trials.

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." 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 Criteria: * 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.

Locations (1)

University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology

Pittsburgh, Pennsylvania, United States