Low-level Laser and Lifestyle Modifications

Prior treatment

• 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 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)
• surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment
• active infection, wound or other external trauma to the areas to be treated with the laser
• current active cancer or currently receiving treatment for cancer; or

Other illness

• 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 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
• 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
• known photosensitivity disorder
• have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

Other

• 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
• medical, physical, or other contraindications for body sculpting/weight loss

• 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