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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum laser acupuncture | Experimental | verum laser acupuncture |
|
| sham laser acupuncture | Sham Comparator | sham laser acupuncture (no laser output) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 weeks |
| Body Fat Percentage (BFP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20821818 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verum Laser Acupuncture | verum laser acupuncture 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. |
| FG001 | Sham Laser Acupuncture | sham laser acupuncture (no laser output) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verum Laser Acupuncture | verum laser acupuncture 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | kg/m^2 | up to 3 weeks, 3 months after study completion |
|
3.75 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verum Laser Acupuncture | verum laser acupuncture 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wen-Long Hu | Kaohsiung Chang Gung Memorial Hospital | +886-7-731-7123 | 2334 | oolonghu@gmail.com |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
|
| 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. |
|
The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.
| up to 3 weeks |
| BG001 | Sham Laser Acupuncture | sham laser acupuncture (no laser output) 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
sham laser acupuncture (no laser output) 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ratio | up to 3 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | % of body weight | up to 3 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Sham Laser Acupuncture | sham laser acupuncture (no laser output) 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. | 0 | 30 | 0 | 30 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |