Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Multi-acupoint low-level laser therapy
DeviceLow-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 irradiation
DeviceSham 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).
Diet and exercise guidance
BehavioralWHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Laser Acupuncture GroupExperimental treatment 2 interventions
Group B: Control GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change 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 6Secondary outcomes
1
Change in body weight
Body weight (kg) measured using the InBody body composition analyzer.
Time frame
Baseline, Week 3, Week 4, and Week 62
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 63
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 64
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
BaselineSponsors and contacts
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Source ClinicalTrials.gov