Laser Acupuncture for Postpartum Weight Retention
|ClinicalTrials.gov Identifier: NCT02840916|
Recruitment Status : Completed
First Posted : July 21, 2016
Results First Posted : January 16, 2017
Last Update Posted : January 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Weight Retention||Procedure: laser acupuncture Procedure: sham laser acupuncture||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: verum laser acupuncture
verum laser acupuncture
Procedure: laser acupuncture
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.
Other Name: low-level laser therapy
Sham Comparator: sham laser acupuncture
sham laser acupuncture (no laser output)
Procedure: sham laser acupuncture
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.
- Body Mass Index (BMI) [ Time Frame: up to 3 weeks, 3 months after study completion ]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.
- Waist-to-buttock Ratio (WBR) [ Time Frame: up to 3 weeks ]The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
- Body Fat Percentage (BFP) [ Time Frame: up to 3 weeks ]The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840916
|Kaohsiung Chang Gung Memorial Hospital|
|Kaohsiung, Taiwan, 833|