Clinical
Study

Examining the impact of the use of a custom-fitted, FeelWell © compression garment to improve the quality of life of individuals with a BMI ≥40.

Rationale

  • 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 in a negative behavior cycle often incorporating depression and low motivation in an endless cycle.
  • As individuals lose weight, they often suffer from excess skin which also aggravates by chafing (arms, inner thighs), hanging down and interfering with gait, making fitting into clothes difficult, affecting activity, decreasing self-esteem and therefore again, feeding into the cycle described above at a time when movement is critical to weight maintenance.
  • Plastic surgery to remove excess skin is an option for some patients; however, surgical risks, the need for multiple surgeries, and lack of insurance coverage often makes surgery unfeasible
  • Given that obesity is a chronic disease, it is sensible to utilize practical approaches to improve an individual’s quality of life and promote behaviors that reinforce in a positive way, sustainable weight change.

This research study aims to assess

  • The effect of wearing a custom-fitted, FDA-registered compression garment (FeelWell Compression, Inc.) by an individual with a BMI ≥40 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, body-image and comfort with the use of a compression garment
  • The impact of the compression garment on activity, strength and movement of an individual with a BMI ≥40 over the period of one year
  • The potential impact of the use of this garment on weight loss and change in laboratory measures of metabolic health

Study design

Randomized, open-label study to evaluate the effect of a compression garment on activity, strength, ease of movement, and quality of life in patients with BMI ≥40 over a period of 1 year.

Inclusion & exclusion criteria

Inclusion criteria

  • Male or female, over 18 years old
  • BMI of ≥ 40
  • 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
  • Unwillingness to participate fully in trial
  • Participation in another trial at the same time
  • Patient Health Questionnaire 9 (PHQ-9) ≥15
  • Investigator’s discretion

Objectives

Primary objectives

  • To compare the effect of the use of a compression garment vs. absence of such garment on activity, strength and ease of movement of subjects with a BMI ≥40 over the period of one year.
  • To compare the effect of the use of a compression garment vs. absence of such garment on quality of life as measured by assessing an individual’s level of pain, mood, body-image and comfort in subjects with a BMI ≥40 over the period of one year.

Secondary objectives

  • To compare the effect of the use of a compression garment vs. absence of such garment in subjects with a BMI ≥40 on weight loss and change in laboratory measures of metabolic health over one year.

Become an exclusive FeelWell Compression partner

As a weight loss professional, you can become an exclusive supplier of our garments and accessories. FeelWell will provide you with a comprehensive service to train your staff. We can also provide our service directly at your office for the convenience of your patients.

There are no fees, inventory, or contractual commitments required.

Contact us to join

You want your patients to succeed in their weight loss surgery. Give them the best support with FeelWell Compression.

  • 202-816-0811
  • contact@feelwellusa.com