Menopause, Perimenopause, Obesity, Overweight
Conditions
Keywords
Laser acupuncture, Low-level laser therapy, Obesity, Menopause, Body composition, Weight management, Acupoint stimulation, Randomized controlled trial
Brief summary
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.
Detailed description
\*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
Interventions
DEVICEMulti-acupoint low-level laser therapy
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).
DEVICESham Laser irradiation
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).
BEHAVIORALDiet and exercise guidance
WHO guideline-based diet and exercise counseling; weekly 5-10 minute sessions including waist, hip, and body composition monitoring.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Random 1:1 allocation: Experimental vs. Control Experimental group: Laser acupuncture + diet/exercise Control group: Sham laser + diet/exercise Assessments at baseline, mid-treatment, post-treatmen
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body fat mass | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | Baseline, Week 3, Week 4, and Week 6 | Body weight (kg) measured using the InBody body composition analyzer. |
| Change in menopausal symptoms (Menopause Rating Scale score) | Baseline and Week 6 | 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. |
| Change in satiety level (Visual Analog Scale) | Baseline and Week 6 | 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. |
| Menopausal constitution classification score | Baseline | 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. |
| Change in skeletal muscle mass | Baseline, Week 3, Week 4, and Week 6 | Skeletal muscle mass (kg) measured using the InBody body composition analyzer. |
| Change in body fat percentage | Baseline, Week 3, Week 4, and Week 6 | Body fat percentage (%) measured using the InBody body composition analyzer. |
| Change in waist-to-hip ratio | Baseline, Week 3, Week 4, and Week 6 | Waist-to-hip ratio calculated from waist and hip circumference measurements. |
Countries
Taiwan
Contacts
CONTACTYu Wei Chang
Outcome results
None listed