Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a Clinical Trial of a Bed Scale Device. Overweight Wheelchair Users Will Complete a Weight Loss Program, Half Get Scales at Baseline, Half at Month 6 Those Who Receive the Bed Scales at Baseline Are Expected to Have Increased Weight Loss
The Fast In-Bed Tracking (FIT) System Lifestyle Intervention
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether FIT bed scales help overweight wheelchair users lose weight during a weight loss program. The scales track weight as users get in and out of bed. Half of the group gets the scales at the start, and half gets them at month 6.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and live within about 75 miles of Pittsburgh.
- Use a wheelchair as your main way to get around, and get in and out of bed most nights.
- Be diagnosed as overweight or obese and want to lose weight. Your BMI, a measure based on height and weight, usually must be about 25–40. The range may differ for your condition.
- Own a smartphone and have reliable internet and Wi-Fi.
- Be comfortable using exercise tools, such as stretch bands or hand pedals, and be able and willing to do medium-effort exercise.
- Your weight plus any sleep partner's weight must total about 600 pounds or less. Your bedroom must work with the bed scales.
- Have no regular way to weigh yourself, or agree not to use your usual weighing device during the study.
- Be able to make your own decisions, as checked by a survey. The study team may allow exceptions for BMI, how often you get in and out of bed, or where you live.
Who can't join
- Plan trips or absences longer than 2–4 weeks in the next year, or plan to move about 75 miles or more from Pittsburgh. The team may review location rules case by case.
- Have a BMI outside the range the study team sets for your condition. The team reviews this case by case.
- Take weight loss drugs or drugs that affect appetite, or have had weight loss surgery in the past 2 years. The team decides which appetite-affecting drugs rule you out.
- Have had an eating disorder in the past 2 years, such as anorexia, bulimia, or binge eating disorder.
- Be pregnant or plan to become pregnant in the next 12 months.
- Regularly have 4 or more alcoholic drinks a day.
- Have a condition that limits your ability to make your own decisions, or a survey shows you cannot make these decisions on your own.
- A survey shows your bedroom setup will not work with the FIT bed scales.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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) * Has been diagnosed as obese or overweight * Are interested in losing weight * BMI in the range of approximately 25 to 40; BMI range will be determined from published evidence for the primary diagnosis of the participant. For example, spinal cord injury /quadriplegic BMI range of approximately 22 to 40; for amputees it will be based on location and level of amputation, or if no diagnosis specific evidence exists, a BMI of approximately 25 to 40 will be used as a general guideline. * Own a smart phone, and have reliable internet and wifi connection * Are comfortable using exercise equipment like resistance bands or hand pedal exercisers * Are able and willing to engage in exercise of moderate intensity * Weight in bed including sleep partner is an estimated combined weight of 600 pounds or less * Does not have a regular way to weigh themselves, such as a roll-on scale in the home or gym, or have regular access to a device to weigh themselves regularly and are willing to avoid weighing themselves during the trial. * Indication that the participant has autonomy in decision-making as determined by the "Everyday Autonomy Self-Determination Scale." * Indication that their current bedroom setup is compatible with the FIT bed scales as determined by the "Bed Determination Survey." Due to the medical complexity of this population, inclusion of this study based on BMI, in-bed transfer frequency, or geographic location will be at the discretion of the expert members of our study team and will be considered on a case-by-case basis. Exclusion Criteria: * 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 * Currently pregnant or intend to become pregnant in the next 12 months * Regularly have 4 or more alcoholic drinks a day * Have any cognitive conditions that limit decision making or self-governing. * Indication that the participant does not have autonomy in decision-making as determined by the "Everyday Autonomy Self-Determination Scale." * Indication that their current bedroom setup is not compatible with the FIT bed scales as determined by the "Bed Determination Survey." Due to the medical complexity of this population, exclusion from this study based on BMI, geographic location, and what is considered a "medication that affects appetite" will be at the discretion of the expert members of our study team and will be considered on a case-by-case basis.
Study sites (1)
PA
- University of Pittsburgh, Bakery Square, Department of Rehabilitation Science and Technology · Pittsburgh, PA 15206Daniel Rusnak, MS · Study contact · 412-624-8575 · dar27@pitt.eduHolly Wilson-Jean, PhD · Study contact · 412-648-3342 · HOW34@pitt.eduJonathan Pearlman, PhD · Principal investigatorMore trials in Pittsburgh