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.

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jonathan Pearlman
Study ID
NCT07141342
Status
Recruiting
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Conditions

  • Disability Physical
  • Obesity; Overweight
  • Wheelchair

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Fast In-Bed Tracking System (FIT) Weight Scale — DEVICE
    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.
  • Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) intervention — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and TechnologyPittsburghPennsylvania15206
Daniel Rusnak, MS
[email protected]
412-624-8575
Holly Wilson-Jean, PhD
[email protected]
412-648-3342
Jonathan Pearlman, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology· Pittsburgh, PA

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