Fast In-Bed Tracking System for Obesity

Overseen By Jonathan Pearlman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonathan Pearlman

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Alcoholism, Cognitive conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 12 months

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jonathan Pearlman, PhD

Principal Investigator

University of Pittsburgh

Katherine Froehlich-Grobe, PhD

Principal Investigator

Craig Hospital

Are You a Good Fit for This Trial?

This trial is for overweight wheelchair users who want to participate in a weight loss program. Participants must be willing to use the FIT bed scale device and follow the GLB-AIM intervention, which is adapted for individuals with impaired mobility.

Inclusion Criteria

Own a smart phone, and have reliable internet and wifi connection

Live within 75 miles of Pittsburgh

I want to lose weight.

Exclusion Criteria

I do not have any cognitive conditions that affect my decision-making.

I am considered unable to make my own decisions as per a specific assessment.

Extended vacations or absences planned in the next year (more that 2 - 4 weeks) or plans to move 75 miles or greater from the Pittsburgh region

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants are oriented to the study, and baseline measurements are taken, including weight and body composition.

1 week

1 visit (in-person)

Treatment

Participants receive the GLB-AIM intervention, with the experimental group using the FIT system for daily weight monitoring.

12 months

13 weekly sessions, 3 bi-weekly sessions, 7 monthly sessions

Follow-up

Participants are monitored for weight loss and other health outcomes after the intervention.

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The trial tests the Fast In-Bed Tracking (FIT) System, an IoT monitoring system integrated into beds for real-time weight tracking. It's paired with a lifestyle intervention (GLB-AIM) designed for those with mobility impairments.

How Is the Trial Designed?

Group I: GLB-AIM + FIT Weight Scales Experimental Treatment 2 Interventions

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.

Group II: GLB-AIM Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Jonathan Pearlman

Lead Sponsor

Trials

2

Recruited

20+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

NuRelm, Inc.

Industry Sponsor

Trials

1

Recruited

150+

Craig Hospital

Collaborator

Trials

45

Recruited

8,400+