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
• Sponsor: Chang Gung Memorial Hospital
• Information provided by (Responsible Party): Wen-Long Hu, Chang Gung Memorial Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postpartum Weight Retention	Procedure: laser acupuncture; Procedure: sham laser acupuncture	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, 833

Sponsors and Collaborators

Chang Gung Memorial Hospital

More Information

Publications of Results:

Hu WL, Chang CH, Hung YC. Clinical observations on laser acupuncture in simple obesity therapy. Am J Chin Med. 2010;38(5):861-7.

• Responsible Party: Wen-Long Hu, Deputy director, Department of Chinese Medicine, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02840916
• Other Study ID Numbers: CMRPG8C0691
• First Posted: July 21, 2016
• Results First Posted: January 16, 2017
• Last Update Posted: January 16, 2017
• Last Verified: November 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Wen-Long Hu, Chang Gung Memorial Hospital:

Laser acupuncture; Postpartum weight retention; Obesity

Additional relevant MeSH terms:

Body Weight; Gestational Weight Gain; Weight Gain; Body Weight Changes