Laser Acupuncture for Postpartum Weight Retention

Study Overview
=================
Brief Summary
-----------------
Objective: To determine the therapeutic effect of acupuncture on postpartum weight retention. Methods: 66 subjects after delivery with postpartum weight retention will be randomly divided into laser acupuncture and control group. A single-blind clinical trial will be conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. After about 3 weeks of treatment, the differences of the subjects' body weight, body mass index, and waist circumference will be analyzed with ANOVA between laser acupuncture and control group.

Detailed Description
-----------------
Objective: Gestational weight gain and weight retention at 1 year after delivery are associated with long-term obesity. The investigators aimed to investigate the effect of laser acupuncture therapy (LAT) on postpartum weight control. Methods: The investigators randomly assigned 66 subjects with postpartum weight retention to a laser acupuncture group and control group. The subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25 (Tianshu), ST28 (Shuidao), ST40 (Fenglong), SP15 (Daheng), CV9 (Shuifen), and SP6 (Sanyinjiao) by using verum or sham laser acupuncture over 5 sessions per week. After 12 treatment sessions, the differences in the body mass index (BMI), body fat percentage (BFP), and waist-to-buttocks ratio (WBR) of the patients were analyzed, and compared between the laser acupuncture and control groups via analysis of variance, chi-square tests, and stepwise regression tests.

Official Title
-----------------
Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial

Conditions
-----------------
Postpartum Weight Retention

Intervention / Treatment
-----------------
* Procedure: laser acupuncture
* Procedure: sham laser acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postpartum duration of <1 month; body mass index (BMI) > 25; age > 20 years; did not use any other medications for weight loss during the study period; and provided informed consent. Exclusion Criteria: presence of a pacemaker; history of seizure or epilepsy; taking immunosuppressant medication; cancer; infectious disease of the skin; taking medications for weight loss, including Chinese herbal preparations, during the study period; receiving other treatment, including supplements, herbs, and medications for weight gain prior to entering the study; comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would affect the findings; unable to undergo LAT due to other medical conditions; and lack of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: verum laser acupuncture<br>verum laser acupuncture | Procedure: laser acupuncture<br>* Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.<br>* Other names: low-level laser therapy;|
| Sham Comparator: sham laser acupuncture<br>sham laser acupuncture (no laser output) | Procedure: sham laser acupuncture<br>* Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion. | up to 3 weeks, 3 months after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist-to-buttock Ratio (WBR) | The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks. | up to 3 weeks | 
| Body Fat Percentage (BFP) | The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks. | up to 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laser acupuncture, Postpartum weight retention, Obesity