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.
\*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: Conducted at baseline, mid-treatment, and post-treatment Safety and tolerability monitored throughout the study \*Statistical Analysis: Software: SPSS Methods: Independent t-tests, paired t-tests, Chi-square tests, correlation, regression analyses Significance: p \< 0.05
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Low-level laser therapy, 780 nm wavelength, 30 minutes per session, 12 sessions over 6 weeks, targeting 10 acupoints: bilateral Shenshu (BL23), Sanyinjiao (SP6), Tianshu (ST25), Shuifen (CV9), Guanyuan (CV4), and Dàdài (GB26).
Sham laser treatment that mimics the appearance and procedure of active low-level laser therapy but does not emit therapeutic laser energy. Sessions are conducted twice weekly for 6 weeks (12 sessions total).
WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
Chang Gung Memorial Hospital, Keelung Medical Center
Keelung, Taiwan, Taiwan
RECRUITINGChange in body fat mass
Body fat mass (kg) measured using bioelectrical impedance analysis (InBody body composition analyzer). Measurements will be performed by trained research staff.
Time frame: Baseline, Week 3, Week 4, and Week 6
Change in body weight
Body weight (kg) measured using the InBody body composition analyzer.
Time frame: Baseline, Week 3, Week 4, and Week 6
Change in menopausal symptoms (Menopause Rating Scale score)
Menopausal symptoms assessed using the validated Traditional Chinese version of the Menopause Rating Scale (MRS). The MRS consists of 11 items scored from 0-4, total score range 0-44, with higher scores indicating more severe symptoms.
Time frame: Baseline and Week 6
Change in satiety level (Visual Analog Scale)
Satiety level assessed using a 100-mm visual analog scale (VAS), where 0 indicates "not satisfied at all" and 100 indicates "extremely satisfied." Participants will rate their average satiety over the past 7 days.
Time frame: Baseline and Week 6
Menopausal constitution classification score
Menopausal constitution assessed using the 37-item Questionnaire of Menopausal Constitution. Scores are calculated according to published scoring criteria, with transformed scores ranging from 0-100 for six constitution types.
Time frame: Baseline
Change in skeletal muscle mass
Skeletal muscle mass (kg) measured using the InBody body composition analyzer.
Time frame: Baseline, Week 3, Week 4, and Week 6
Change in body fat percentage
Body fat percentage (%) measured using the InBody body composition analyzer.
Time frame: Baseline, Week 3, Week 4, and Week 6
Change in waist-to-hip ratio
Waist-to-hip ratio calculated from waist and hip circumference measurements.
Time frame: Baseline, Week 3, Week 4, and Week 6
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