Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laser Acupuncture for Postpartum Weight Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by (Responsible Party):
Wen-Long Hu, Chang Gung Memorial Hospital

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840916


Locations
Layout table for location information
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: Wen-Long Hu, Deputy director, Department of Chinese Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02840916     History of Changes
Other Study ID Numbers: CMRPG8C0691
First Posted: July 21, 2016    Key Record Dates
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:
Layout table for MeSH terms
Body Weight
Gestational Weight Gain
Signs and Symptoms
Weight Gain
Body Weight Changes