Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
Status unconfirmed · Not applicable
Conditions studied: Obesity, Obesity, Abdominal, Mobility Limitation, Quality of Life, Back Pain, Pain, Chronic, Weight Change, Body, Inactivity, Exercise, Body Composition, Redundant Skin
In brief
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 period of one year. Various measures of quality of life will be taken, including assessing an individual's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additionally, to assess the impact of the compression garment on activity, strength, posture and movement of an individual with a BMI ≥35 over the period of one year.
Key facts
- Study ID
- NCT03798873
- Run by
- Feelwell Compression
- People needed
- 30
- Starts
- 2019-02-13
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2019-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, over 18 years old.
- Subjects with a BMI of ≥ 35.
- Subjects in any stage of weight loss or maintenance.
You may not qualify if…
- 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
Where it is running
- Washington Center for Weight Management and Research, Inc. — Shirlington, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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