Effects of a Multi-acupoint Laser Therapy Device on Body Shape and Body Composition in Obese Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in body fat mass
研究概览
简要总结
The purpose of this study is to integrate Traditional Chinese Medicine (TCM) theory and therapeutic methods with modern low-level laser stimulation on corresponding acupoints, applying this combined approach to the field of weight management in menopausal women. The trial aims to investigate whether lifestyle modifications in accordance with WHO guidelines (dietary control and exercise), combined with adjunctive low-level laser acupuncture, can enhance weight reduction and improve body composition more effectively than standard lifestyle interventions alone.
详细描述
*Study Objective: Investigate the effects of multi-acupoint low-level laser therapy on body composition in obese menopausal women, combining traditional Chinese medicine theory with laser stimulation of specific acupoints, alongside lifestyle interventions including diet and exercise according to WHO guidelines.
*Participants: Total: 40 women, aged 45-55 years BMI > 24 kg/m² or waist-to-hip ratio > 0.88 Recruited from the outpatient clinic Randomly assigned to either the laser acupuncture group or control group
*Intervention: Experimental group: 12 sessions of laser acupuncture over 6 weeks Each session: 30 minutes, targeting 10 acupoints related to weight management Both groups: standardized diet and exercise guidance per WHO recommendations
*Primary Endpoints: Body composition changes:Body fat mass, Body fat percentage, Skeletal muscle mass, Total body weight, Limb muscle mass, Waist-to-hip ratio
- Secondary Endpoints: Menopausal symptoms (Menopause Rating Scale, MRS), Satiety levels (Visual Analog Scale, VAS)
- Assessments:
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
- Double (Participant, Investigator)
盲法说明
Both participants and investigators administering the treatment will be blinded to group assignment.
The control group will receive a sham laser treatment that mimics the appearance and procedure of the active laser therapy but does not emit therapeutic laser energy.
Outcome assessors will also be blinded to group allocation to reduce assessment bias.
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 45 to 55 years
- •No cognitive impairment or major psychiatric disorder
- •Able to understand the study procedures and communicate with research staff
- •Body mass index (BMI) > 24 kg/m² OR waist-to-hip ratio > 0.88
排除标准
- •Pregnant or possibly pregnant women
- •Diagnosed chronic diseases currently under active treatment, including hepatitis, chronic kidney disease, chronic gastrointestinal disease, cardiovascular disease, or cancer
- •Systemic diseases such as hyperthyroidism, hypothyroidism, compensated liver cirrhosis, or autoimmune disorders
- •Currently receiving weight control treatment, including bariatric surgery or weight-loss medications
- •History of epilepsy or seizure disorder
- •Coagulation disorders or current use of anticoagulant therapy
研究组 & 干预措施
Laser Acupuncture Group
Participants receive multi-acupoint low-level laser therapy combined with diet and exercise guidance. Treatment is delivered twice weekly for 6 weeks (12 sessions total), targeting 10 specific acupoints related to weight management. Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment.
干预措施: Multi-acupoint low-level laser therapy (Device)
Laser Acupuncture Group
Participants receive multi-acupoint low-level laser therapy combined with diet and exercise guidance. Treatment is delivered twice weekly for 6 weeks (12 sessions total), targeting 10 specific acupoints related to weight management. Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment.
干预措施: Diet and exercise guidance (Behavioral)
Control Group
Participants receive sham laser treatment combined with diet and exercise guidance. The sham procedure mimics the appearance and treatment process of active laser therapy but does not emit therapeutic laser energy. Participants will receive treatment twice weekly for 6 weeks (12 sessions total). Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment.
干预措施: Sham Laser irradiation (Device)
Control Group
Participants receive sham laser treatment combined with diet and exercise guidance. The sham procedure mimics the appearance and treatment process of active laser therapy but does not emit therapeutic laser energy. Participants will receive treatment twice weekly for 6 weeks (12 sessions total). Body composition and menopausal symptom assessments will be conducted at baseline, mid-treatment, and post-treatment.
干预措施: Diet and exercise guidance (Behavioral)
结局指标
主要结局
Change in body fat mass
时间窗: Baseline, Week 3, Week 4, and Week 6
Body fat mass (kg) measured using bioelectrical impedance analysis (InBody body composition analyzer). Measurements will be performed by trained research staff.
次要结局
- Change in body weight(Baseline, Week 3, Week 4, and Week 6)
- Change in menopausal symptoms (Menopause Rating Scale score)(Baseline and Week 6)
- Change in satiety level (Visual Analog Scale)(Baseline and Week 6)
- Menopausal constitution classification score(Baseline)
- Change in skeletal muscle mass(Baseline, Week 3, Week 4, and Week 6)
- Change in body fat percentage(Baseline, Week 3, Week 4, and Week 6)
- Change in waist-to-hip ratio(Baseline, Week 3, Week 4, and Week 6)