Low-level Laser and Lifestyle Modifications

Study Overview
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Brief Summary
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The purpose of this research study is to evaulate the effectiveness of Low Level Laser Therapy in combination with Lifestyle Modifications in helping people reduce the extra weight and size in the central body region

Detailed Description
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Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.

Official Title
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A Feasibility Study Addressing the Adjunct Use of Low-Level Laser to Mayo Lifestyle Modification Education and Wellness Coaching for Reducing Central Adiposity and Fat Mass

Conditions
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Overweight and Obesity, Weight Loss

Intervention / Treatment
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* Device: Low Level Laser Therapy
* Other: Sham (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older have a BMI 25-39.9 kg/m2 be able to participate fully in all aspects of the study; and have understood and signed study informed consent Exclusion Criteria: have used weight loss medications or participated in a weight loss program within the past 30 days are currently taking medications or supplements known to affect weight, such as insulin or sulfonylurea, prednisone or garcinia cambrogia have had weight fluctuations of 5 pounds or more in the past month have an implanted device (including pacemaker or lap band) in the targeted area of LLLT have a known active eating disorder have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression) have used an investigational drug within 30 days of study enrollment Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the low-level laser therapy treatment phase and are unwilling to use a reliable form of contraception. Acceptable forms include: Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm) Intrauterine device (IUD) Total hysterectomy or tubal ligation Abstinence (no sex) have a history of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as uncontrolled diabetes type 2) or active cancer or are within 1 year of cancer remission surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment medical, physical, or other contraindications for body sculpting/weight loss any medical condition known to affect weight levels and/or to cause bloating or swelling a diagnosis of, and/or taking medication for, irritable bowel syndrome active infection, wound or other external trauma to the areas to be treated with the laser known photosensitivity disorder current active cancer or currently receiving treatment for cancer; or have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial where subjects are placed into 2 different study arms. Subjects randomized to 2 groups that either receive Low Level Laser therapy with lifestyle modifications or Sham (placebo) with Lifestyle Modifications.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 - LLLT<br>Subject receive Laser treatments and Lifestyle Modifications | Device: Low Level Laser Therapy<br>* Non-surgical cosmetic treatment which can be used by individuals intending to reduce size of the mid-section<br>|
| Sham Comparator: Group 2 - SHAM<br>Subject receives Sham Laser treatments and Lifestyle Modifications | Other: Sham (placebo)<br>* Use of sham (placebo) option<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of fat mass loss | Compare the amount of fat mass loss at the end of treatments | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, Fat Mass, Weight Loss, Body Circumference Reduction