Clinical trial NCT03798873: Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Obesity, Abdominal
Mobility Limitation
Quality of Life
Back Pain
Pain, Chronic
Weight Change, Body
Inactivity
Exercise
Body Composition
Redundant Skin
Keywords: Compression garment
Physical therapy
Obesity
Movement
Abdominal binder
Lead sponsor: Feelwell Compression
Sponsor class: INDUSTRY
Collaborators: name: Washington Center for Weight Management and Research, Inc.
First posted: 2019-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group treated with the FeelWell™ Compression garment and control group without compression garment. All subjects will receive the same intervention working with exercise physiologist and physical therapist in order to improve mobility.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6- minute walk test- distance walked
timeFrame: baseline, 1, 3, 6 and 12 months
measure: 6- minute walk test- Perceived exertion
timeFrame: baseline, 1, 3, 6 and 12 months
measure: SF-36 physical component sub-score
timeFrame: baseline, 3, 6 and 12 months
measure: 30 Second Chair Stand
timeFrame: baseline, 1, 3, 6 and 12 months
measure: Brief Pain Inventory-Interference sub-score
timeFrame: baseline, 1, 3, 6 and 12 months
measure: Steps per day measured by accelerometer
timeFrame: baseline, 6 months and 1 year
measure: Weight Self Stigma questionnaire
timeFrame: baseline, 1, 3, 6 and 12 months
Secondary outcomes:
measure: Lean body mass
timeFrame: baseline, 12 months
measure: Fat mass
timeFrame: baseline, 12 months
measure: Bone density
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Shirlington
country: United States
facility: Washington Center for Weight Management and Research, Inc.
state: Virginia
Study officials:
affiliation: Washington Center for Weight Management and Research
name: Domenica Rubino, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jakicic JM, Rogers RJ, Davis KK, Collins KA. Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity. Clin Chem. 2018 Jan;64(1):99-107. doi: 10.1373/clinchem.2017.272443. Epub 2017 Nov 20.
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