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 trial tests a new bed-based system designed to track weight effortlessly, particularly benefiting wheelchair users who want to lose weight. The focus is on refining and testing this system, which records weight changes when users get on and off their beds, simplifying weight management. Participants will follow a weight loss program called Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM), tailored for people with impaired mobility. Some participants will use the new bed system as part of the trial. Ideal candidates are wheelchair users who want to lose weight but lack a convenient way to weigh themselves regularly. As an unphased trial, this study offers participants the chance to contribute to innovative solutions for weight management in individuals with impaired mobility.

Will I have to stop taking my current medications?

If you are currently taking weight loss medication or medications that affect appetite, you will need to stop taking them to participate in this trial.

What prior data suggests that the Fast In-Bed Tracking System is safe for weight monitoring in wheelchair users?

Research has shown that the Fast In-Bed Tracking System (FIT) received positive feedback in earlier trials. Users found it easy to use and helpful for tracking their weight. The system allows weight monitoring without needing a regular scale, which is especially convenient for wheelchair users.

Community-based trials demonstrated that people quickly learned to use the FIT system. Participants felt confident using it, and it was not considered difficult to operate. No major reports of negative effects have emerged from using the FIT system.

Although improvements to the FIT system continue, these early results suggest it is a safe and easy-to-use option for managing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fast In-Bed Tracking System (FIT) for obesity because it introduces a unique self-monitoring approach tailored for individuals with impaired mobility. Unlike standard lifestyle interventions that might not include real-time weight tracking, the FIT system allows participants to monitor their weight daily from home. This immediate feedback can enhance motivation and adherence to weight management goals. Additionally, by integrating a mobile app for tracking food intake and exercise, the intervention personalizes the weight loss journey, potentially leading to more sustainable results.

What evidence suggests that the Fast In-Bed Tracking System is effective for supporting weight loss in wheelchair users?

This trial will compare the effectiveness of the Fast In-Bed Tracking (FIT) System with the Group Lifestyle Balance Adapted for Individuals with Impaired Mobility (GLB-AIM) program. Research has shown that the FIT system can aid in weight loss. In a previous study, participants using the FIT system lost an average of 1.7 kg over six months, while those not using it gained a small amount of weight. The system automatically checks weight when users get on and off the bed, simplifying weight tracking for those who find regular weighing challenging. By making weight monitoring easier, FIT helps individuals stay committed to their weight loss goals. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine Froehlich-Grobe, PhD

Principal Investigator

Craig Hospital

Jonathan Pearlman, PhD

Principal Investigator

University of Pittsburgh

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07141342

Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a ... 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 ...

2. withpower.com withpower.com/trial/phase-obesity-7-2025-29a7f

Fast In-Bed Tracking System for Obesity 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 ...

3. app.trialscreen.org app.trialscreen.org/trials/fast-bed-tracking-fit-system-lifestyle-intervention-clinical-scale-device-trial-nct07141342

Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a ... Benefits: Participants may experience weight loss through the structured lifestyle program. Those receiving the bed scale will have convenient, automatic weight ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9690470/

Design and Development of Smart Weight Measurement ... This paper presents the design and development of a smart and cost-effective independent system for lateral rotation, movement, weight measurement, and ...

5. jmir.org jmir.org/2022/12/e39489/PDF

Tracking Continuous Positive Airway Pressure Adherence as Objective: This study aimed to develop a mobile health tool that combined weight loss features with novel CPAP adherence tracking (ie, ...

6. d-scholarship.pitt.edu d-scholarship.pitt.edu/34172/7/duvall_etd2018.pdf

weight monitoring in bed using e-scale - D-Scholarship@Pitt learn to use this system very quickly. 8. I found the system very cumbersome to use. 9. I felt very confident using the system. 10. I needed to ...