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

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.

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

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

Sponsors & Collaborators

• Washington Center for Weight Management and Research, Inc.

  collaborator UNKNOWN

• Feelwell Compression

  lead INDUSTRY

Principal Investigators

• Domenica Rubino, MD · Washington Center for Weight Management and Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-13

Primary Completion

2020-07-31

Completion

2020-07-31

FDA Device

Yes

Countries

• United States

Study Locations