NCT03798873

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Feelwell Compression · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Obesity
• Obesity, Abdominal
• Mobility Limitation
• Quality of Life
• Back Pain
• Pain, Chronic
• Weight Change, Body
• Inactivity
• Exercise
• Body Composition
• Redundant Skin

Interventions

Type	Name	Description
DEVICE	FeelWell™ Compression garment	Registered FDA class I device: The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back.
BEHAVIORAL	Increase Mobility	Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity

Timeline

• Start date: 2019-02-13
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2019-01-10
• Last updated: 2019-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study