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.

NARecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

September 30, 2027

Conditions
Disability PhysicalWheelchairObesity; 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.

Trial Locations (1)

15206

RECRUITING

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

All Listed Sponsors
collaborator

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

NIH

collaborator

NuRelm, Inc.

INDUSTRY

collaborator

Craig Hospital

OTHER

lead

Jonathan Pearlman

OTHER

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. | Biotech Hunter | Biotech Hunter