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New treatment option for Disability Physical
Official title 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.
ClinicalTrials.gov ID: NCT07141342
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.