Laser Acupuncture for Postpartum Weight Retention

NCT02840916 | Completed Phase 3 Results

• 1 other identifier: CMRPG8C0691
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Weight Retention

Keywords

Laser acupuncture; Postpartum weight retention; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Waist-to-buttock Ratio (WBR)

  up to 3 weeks

• Body Fat Percentage (BFP)

  up to 3 weeks

Study Arms (2)

verum laser acupuncture

EXPERIMENTAL

verum laser acupuncture

Procedure: laser acupuncture

sham laser acupuncture

SHAM COMPARATOR

sham laser acupuncture (no laser output)

Procedure: sham laser acupuncture

Interventions

laser acupuncture PROCEDURE

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.

Also known as: low-level laser therapy

verum laser acupuncture

sham laser acupuncture PROCEDURE

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.

sham laser acupuncture

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related 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. doi: 10.1142/S0192415X10008305.

  PMID: 20821818 RESULT

MeSH Terms

Conditions

Gestational Weight Gain; Obesity

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

The postpartum weight trend cannot be assessed. The average duration of admission in our postpartum care center was 18.6 days. Some confounders should also be considered. The lack of follow-up for BFP and WBR after 1 and 3 months may be limitations.

Results Point of Contact

• Title: Dr. Wen-Long Hu
• Organization: Kaohsiung Chang Gung Memorial Hospital

oolonghu@gmail.com

+886-7-731-7123

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director, Department of Chinese Medicine

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 21, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 16, 2017
• Results First Posted: January 16, 2017

Record last verified: 2016-11

Locations

TW (1)