Laser Acupuncture for Postpartum Weight Retention
Primary Purpose
Postpartum Weight Retention
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
laser acupuncture
sham laser acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Weight Retention focused on measuring Laser acupuncture, Postpartum weight retention, Obesity
Eligibility 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.
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
verum laser acupuncture
sham laser acupuncture
Arm Description
verum laser acupuncture
sham laser acupuncture (no laser output)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Waist-to-buttock Ratio (WBR)
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)
The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Full Information
NCT ID
NCT02840916
First Posted
July 14, 2016
Last Updated
November 20, 2016
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02840916
Brief Title
Laser Acupuncture for Postpartum Weight Retention
Official Title
Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Weight Retention
Keywords
Laser acupuncture, Postpartum weight retention, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
verum laser acupuncture
Arm Type
Experimental
Arm Description
verum laser acupuncture
Arm Title
sham laser acupuncture
Arm Type
Sham Comparator
Arm Description
sham laser acupuncture (no laser output)
Intervention Type
Procedure
Intervention Name(s)
laser acupuncture
Other Intervention Name(s)
low-level laser therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham laser acupuncture
Intervention Description
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 Measure Information:
Title
Body Mass Index (BMI)
Description
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.
Time Frame
up to 3 weeks, 3 months after study completion
Secondary Outcome Measure Information:
Title
Waist-to-buttock Ratio (WBR)
Description
The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Time Frame
up to 3 weeks
Title
Body Fat Percentage (BFP)
Description
The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
Time Frame
up to 3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20821818
Citation
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.
Results Reference
result
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Laser Acupuncture for Postpartum Weight Retention
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