Laser Acupuncture for Postpartum Weight Retention

Postpartum Weight Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840916
• Other study ID #: CMRPG8C0691
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2016
• Last updated: July 19, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Postpartum Weight Retention

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index (BMI)	Change from Baseline BMI was assessed by an evaluator who was blinded to the intervention details through study completion, up to 3 weeks, and 3 months after study completion.	up to 3 weeks, 3 months after study completion	No
Secondary	waist-to-buttocks ratio (WBR)	Change from Baseline WBR was assessed by an evaluator who was blinded to the intervention details through study completion, up to 3 weeks, and 3 months after study completion.	up to 3 weeks, 3 months after study completion	No
Secondary	body fat percentage (BFP)	Change from Baseline BFP was assessed by an evaluator who was blinded to the intervention details through study completion, up to 3 weeks, and 3 months after study completion.	up to 3 weeks, 3 months after study completion	No