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

Not Applicable

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

• Registration Number: NCT03798873
• Lead Sponsor: Feelwell Compression

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.

Study Timeline

• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-10
• Status Verified: 2019-02
• Study Start: 2019-02-13
• Last Update Submitted: 2019-02-15
• Last Update Posted: 2019-02-19
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6- minute walk test- distance walked	baseline, 1, 3, 6 and 12 months	6-min walk test is a sub-maximal exercise test measuring the total distance walked by a subject in a period of 6 minutes to assess functional capacity of a subject's cardio-respiratory systems and reflects their ability to perform Activities of Daily Living. Total distance walked will be measured and change recorded from baseline.
Brief Pain Inventory-Interference sub-score	baseline, 1, 3, 6 and 12 months	A measure of pain and the interference of such pain on daily function. A sub-score on a scale of 0 (no interference)- 10 (maximal interference) will be recorded. The mean score of the 7 items will be recorded.
SF-36 physical component sub-score	baseline, 3, 6 and 12 months	SF-36 consists of 8 sub-scales of health-related quality of life measuring various aspects of functioning. The summary score for physical component includes physical functioning, physical role, bodily pain and general health scores. This sub-score is reported on a scale from 0-100 with higher numbers indicating better physical functioning.
Steps per day measured by accelerometer	baseline, 6 months and 1 year	The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
6- minute walk test- Perceived exertion	baseline, 1, 3, 6 and 12 months	The Borg Rate of Perceived Exertion scale of 1-10 will be used for the subject to record their exertion level from 1 (no exertion)-10 (maximal exertion) and change will be noted from baseline.
30 Second Chair Stand	baseline, 1, 3, 6 and 12 months	A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded.
Weight Self Stigma questionnaire	baseline, 1, 3, 6 and 12 months	A questionnaire designed to explore both internalized self stigma (internalized self-devaluation) and enacted stigma (directly experienced stigma) on function will be administered. The scale is comprised of 12 questions, and the subject responds on a scale from 1-5 with a greater score indicating greater experienced stigma.

Secondary Outcome Measures

Name	Time	Method
Lean body mass	baseline, 12 months	Using DXA (Dual-energy X-ray Absorptiometry), lean body mass (LBM) or fat-free mass will be measured at baseline and at end of study. Percent change will be reported.
Fat mass	baseline, 12 months	Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.
Bone density	baseline, 12 months	Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.

Trial Locations

Locations (1)

Washington Center for Weight Management and Research, Inc.; 🇺🇸 Shirlington, Virginia, United States