Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
Unknown statusNot applicableNCT03798873
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Examining the Impact of the Use of a Custom-fitted, FeelWell™ Compression Garment to Improve the Quality of Life of Individuals With a BMI ≥35
- Conditions
- Obesity
- Obesity, Abdominal
- Mobility Limitation
- Quality of Life
- Back Pain
- Pain, Chronic
- Weight Change, Body
- Inactivity
- Exercise
- Body Composition
- Redundant Skin
- Interventions
- Device: FeelWell™ Compression garment
- Behavioral: Increase Mobility
- Sponsor
- Feelwell Compression
- Collaborators
- Washington Center for Weight Management and Research, Inc.
- Start date
- 2019-02-13
- Primary completion
- 2020-07
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or female, over 18 years old. * Subjects with a BMI of ≥ 35. * Subjects in any stage of weight loss or maintenance. Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03798873