ObesityNCT03798873
Impact of the Use of FeelWell™ Compression Garment on Individuals With a BMI ≥35
A study testing FeelWell™ Compression garment and Increase Mobility in people with Obesity and Obesity, Abdominal, run by Feelwell Compression at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity, Abdominal, Mobility Limitation
- What is being tested?
- FeelWell™ Compression garment and Increase Mobility
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to Jul 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, over 18 years old.
- Subjects with a BMI of ≥ 35.
- Subjects in any stage of weight loss or maintenance.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington Center for Weight Management and Research, Inc.
Shirlington, Virginia, 22206
Michelle Vaughan, MBA, 703-807-0037, mvaughan@wtmgmt.com
Rachel Trope, MS, 7038070037, rtrope@wtmgmt.com
About this study
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
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.
Read the 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
- Being tested
- FeelWell™ Compression garment, Increase Mobility
- Keywords
- Compression garment, Physical therapy, Obesity, Movement, Abdominal binder
- Medical subject headings
- Obesity, Obesity, Abdominal, Mobility Limitation, Back Pain, Chronic Pain, Body Weight Changes, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeelWell™ Compression garmentDevice
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.
Increase MobilityBehavioural
Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
| Study group | Role | What they receive |
|---|---|---|
| FeelWell™ Compression garment use with increase mobility | Experimental | Subjects are randomized to wear custom-fitted FeelWell™ Compression garment daily during regular and exercise activities.
Subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. Receives: Device: FeelWell™ Compression garment; Behavioral: Increase Mobility |
| Increase mobility | Other | For the control group, subjects will work with physical therapist and exercise physiologist to increase strength, mobility and activity. The control group will not be assigned a compression garment during the trial. Receives: Behavioral: Increase Mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
6- minute walk test- distance walked
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.
Measured: baseline, 1, 3, 6 and 12 months
6- minute walk test- Perceived exertion
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.
Measured: baseline, 1, 3, 6 and 12 months
SF-36 physical component sub-score
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.
Measured: baseline, 3, 6 and 12 months
30 Second Chair Stand
A test of leg strength and endurance. The number of times a patient stands from a sitting position in 30 seconds is recorded.
Measured: baseline, 1, 3, 6 and 12 months
Brief Pain Inventory-Interference sub-score
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.
Measured: baseline, 1, 3, 6 and 12 months
Steps per day measured by accelerometer
The number of steps per day will be recorded as a measure of daily activity and averaged at various time points throughout the trial.
Measured: baseline, 6 months and 1 year
Weight Self Stigma questionnaire
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.
Measured: baseline, 1, 3, 6 and 12 months
Secondary outcomes (3)
Lean body mass
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.
Measured: baseline, 12 months
Fat mass
Using DXA (Dual-energy X-ray Absorptiometry), fat mass will be measured at baseline and at end of study. Percent change will be reported.
Measured: baseline, 12 months
Bone density
Using DXA (Dual-energy X-ray Absorptiometry), bone density will be measured at baseline and at end of study. Percent change will be reported.
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start13 Feb 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feelwell Compression
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington Center for Weight Management and Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Domenica Rubino, MD, Principal investigator, Washington Center for Weight Management and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798873
- Sponsor's protocol ID
- FeelWell2018
- Status last verified
- Feb 2019
- First submitted
- 13 Dec 2018
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once study is completed, data analyzed and published, data will be made available to any investigator who is interested upon written request.
Publications
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Camarri B, Eastwood PR, Cecins NM, Thompson PJ, Jenkins S. Six minute walk distance in healthy subjects aged 55-75 years. Respir Med. 2006 Apr;100(4):658-65. doi: 10.1016/j.rmed.2005.08.003. Epub 2005 Oct 17.
PubMed 16229997Grodin JL, Hammadah M, Fan Y, Hazen SL, Tang WH. Prognostic value of estimating functional capacity with the use of the duke activity status index in stable patients with chronic heart failure. J Card Fail. 2015 Jan;21(1):44-50. doi: 10.1016/j.cardfail.2014.08.013. Epub 2014 Aug 28.
PubMed 25175697Jakicic 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.
PubMed 29158251Hebert-Losier K, Wessman C, Alricsson M, Svantesson U. Updated reliability and normative values for the standing heel-rise test in healthy adults. Physiotherapy. 2017 Dec;103(4):446-452. doi: 10.1016/j.physio.2017.03.002. Epub 2017 Mar 21.
PubMed 28886865