Recruiting

FIT

Sponsor:

Jonathan Pearlman

Code:

NCT07141342

Conditions

Disability Physical

Wheelchair

Obesity; Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

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 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.

Conditions

Disability Physical

Wheelchair

Obesity; Overweight

Study ID

NCT07141342

Start date

Feb 16, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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 until month 6 and will not have the ability to monitor their weight during core intervention sessions.

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.

Interventions

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

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

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.

Primary outcome measure

  • Weight Loss after 6 and 12 months comparing the intervention group (FIT bed scale with daily weight feedback) versus control group (weighed at baseline, 6 and 12 months) [ Time Frame: Baseline, Month 6, Month 12 ]

Central Contacts and Locations

Central contacts

Daniel Rusnak, MS

412-624-8575dar27@pitt.edu

Jonathan Pearlman, PhD

412-383-3955jpearlman@pitt.edu

Locations

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

Recruiting

Pittsburgh, Pennsylvania, United States, 15206

Contacts

Daniel Rusnak, MS

412-624-8575dar27@pitt.edu

Holly Wilson-Jean, PhD

412-648-3342HOW34@pitt.edu

Principal Investigator:

Jonathan Pearlman, PhD

More Information

Sponsor

Jonathan Pearlman

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Wheelchair
  • Wheelchair Users
  • Weigh loss
  • Weight loss device
  • Weight loss program
  • device research
  • bed scale
  • Wheelchair Scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jonathan Pearlman on 2026-07-29.