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.
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)
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
Parallel
The Fast In-Bed Tracking System (FIT) Weight Scale
DeviceIt 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
BehavioralThe 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.
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)
The difference in weight loss from baseline to 6 and 12 months (intervention versus control groups).
Participant's Adherence to the Diet and Exercise Intervention (Average Days Per Week of Food Tracking)
MyNetDiary food intake entries will be collected from the participant's MyNetDiary account. Adherence to daily food tracking will be reported as average days per week of food tracking.
Participant's Average Daily Caloric Intake when Tracking Food
MyNetDiary food intake entries will be collected from the participant's MyNetDiary account on a weekly basis. Daily caloric intake when tracking food will be calculated by dividing the total amount of calories consumed in the week by the number of days in the week participant's tracked food.
Changes in Participant's Body Composition
Waist Circumference is measured using a tailor's measuring tape, measuring the waist circumference of the participant (just above the navel) in centimeters.
Changes in Participant's Dietary Intake
Changes in dietary intake will be recorded via a 3-day recall using the Automated Self-Administered Dietary Assessment Tool (ASA-24). Targeted categories will include: Total Calories, Fat, Protein, Fruit, and Vegetables.
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Jonathan Pearlman
Lead sponsor
University of Pittsburgh
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
NuRelm, Inc.
Collaborator
Craig Hospital
Collaborator
