Clinical trial NCT02840916: Laser Acupuncture for Postpartum Weight Retention
Official title: Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Weight Retention
Keywords: Laser acupuncture
Postpartum weight retention
Obesity
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 66
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: up to 3 weeks, 3 months after study completion
Secondary outcomes:
measure: Waist-to-buttock Ratio (WBR)
timeFrame: up to 3 weeks
measure: Body Fat Percentage (BFP)
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
citation: Hu WL, Chang CH, Hung YC. Clinical observations on laser acupuncture in simple obesity therapy. Am J Chin Med. 2010;38(5):861-7. doi: 10.1142/S0192415X10008305.