- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02840916
Laser Acupuncture for Postpartum Weight Retention
Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Kaohsiung, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: verum laser acupuncture
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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 Names:
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Sham Comparator: sham laser acupuncture
sham laser acupuncture (no laser output)
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index (BMI)
Time Frame: up to 3 weeks, 3 months after study completion
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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.
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up to 3 weeks, 3 months after study completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist-to-buttock Ratio (WBR)
Time Frame: up to 3 weeks
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The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
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up to 3 weeks
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Body Fat Percentage (BFP)
Time Frame: up to 3 weeks
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The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
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up to 3 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMRPG8C0691
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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