Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35

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

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.

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 ultimately overall quality of life. Many individuals who experience weight gain have an abdominal or central distribution of weight which affects body mechanics leading to back pain, poor posture, difficulty walking with altered gait, knee, foot, ankle and leg pain (IT band, meralgia paresthetica) and other non-specific chronic pain. Chronic pain impedes mobility often incorporating depression and low motivation in an endless cycle. Furthermore, as individuals are losing weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait.

The Investigators will examine the effect of wearing a custom-fitted, FDA-registered, Class I device, compression garment (Obesinov, S.A.R.L.) by participants with a BMI ≥ 35 on day-to-day quality of life over a period of one year. Various measures of quality of life will be taken, including assessing the participant's level of pain, mood, self-stigma and comfort with the use of a compression garment. Additional assessments include impact of the compression garment on activity, strength, posture and movement as well as potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health.

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