NCT05083442已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Fat Mass From Baseline to 6 Weeks
研究概览
简要总结
The purpose of this research study is to evaluate 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
详细描述
Subjects will undergo Low Level Laser Therapy or Sham (placebo) treatments while incorporating lifestyle modifications through of wellness coaching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization will be set up by a statistician through REDCap, the data collection system utilized for the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Fat Mass From Baseline to 6 Weeks
时间窗: 6 weeks
The change in fat mass from baseline to the end of treatments at 6 weeks
Change in Waist Circumference From Baseline to 6 Weeks
时间窗: 6 weeks
The change in waist circumference from baseline to the end of treatments at 6 weeks
次要结局
未报告次要终点
研究者
Ivana T Croghan, PhD
Professor of Medicine, College of Medicine
Mayo Clinic
研究点 (2)
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