Status:
UNKNOWN
Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
Lead Sponsor:
Feelwell Compression
Collaborating Sponsors:
Washington Center for Weight Management and Research, Inc.
Conditions:
Obesity
Obesity, Abdominal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by an individual with a BMI ≥ 35 on his/her day-to-day quality of life over a ...
Detailed Description
Individuals suffering with obesity often experience daily pain and discomfort which limits movement, a critical factor in managing weight, cardio-metabolic health, mood, sleep, self-esteem and ultimat...
Eligibility Criteria
Inclusion
- Male or female, over 18 years old.
- Subjects with a BMI of ≥ 35.
- Subjects in any stage of weight loss or maintenance.
Exclusion
- Inability to put on or have help in putting on garment.
- Inability to participate in movement and exercise intervention.
- Panniculus grade \>3 at baseline or other body habitus that limits mobility.
- Duke Activity Status Index (DASI) score \< 3.62
- Medical condition limiting participation in trial or basic mobility.
- Current participation in a physical therapy program.
- Unwillingness to participate fully in trial.
- Participation in another trial at the same time.
- Patient Health Questionnaire (PHQ)-9≥15.
- Current or expected pregnancy
- Investigator's discretion
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03798873
Start Date
February 13 2019
End Date
July 1 2020
Last Update
February 19 2019
Active Locations (1)
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1
Washington Center for Weight Management and Research, Inc.
Shirlington, Virginia, United States, 22206