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Laser Acupuncture for Postpartum Weight Retention

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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

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 21, 2016
Results First Submitted Date  ICMJE July 23, 2016
Results First Posted Date  ICMJE January 16, 2017
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
Body Mass Index (BMI) [ Time Frame: up to 3 weeks, 3 months after study completion ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Waist-to-buttock Ratio (WBR) [ Time Frame: up to 3 weeks, 3 months after study completion ]
    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.
  • Body Fat Percentage (BFP) [ Time Frame: up to 3 weeks, 3 months after study completion ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Acupuncture for Postpartum Weight Retention
Official Title  ICMJE Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Weight Retention
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: verum laser acupuncture
    verum laser acupuncture
    Intervention: Procedure: laser acupuncture
  • Sham Comparator: sham laser acupuncture
    sham laser acupuncture (no laser output)
    Intervention: Procedure: sham laser acupuncture
Publications * Hu WL, Chang CH, Hung YC. Clinical observations on laser acupuncture in simple obesity therapy. Am J Chin Med. 2010;38(5):861-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840916
Other Study ID Numbers  ICMJE CMRPG8C0691
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wen-Long Hu, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP