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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postpartum Weight Retention
Interventions Procedure: laser acupuncture
Procedure: sham laser acupuncture
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 33 33
Completed 32 30
Not Completed 1 3
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 32 30 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
30
 100.0%
62
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 30 participants 62 participants
34.88  (4.31) 35.70  (3.72) 35.28  (4.02)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
Female
32
 100.0%
30
 100.0%
62
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 32 participants 30 participants 62 participants
32 30 62
1.Primary Outcome
Title Body Mass Index (BMI)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: kg/m^2
baseline 33.62  (3.19) 28.03  (3.04)
up to 3 weeks 26.90  (2.29) 26.99  (3.45)
3 months after study completion 26.16  (2.40) 26.64  (3.40)
2.Secondary Outcome
Title Waist-to-buttock Ratio (WBR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: ratio
baseline 0.93  (0.06) 0.92  (0.06)
up to 3 weeks 0.92  (0.05) 0.90  (0.05)
3.Secondary Outcome
Title Body Fat Percentage (BFP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: % of body weight
baseline 36.94  (2.65) 36.02  (3.87)
up to 3 weeks 35.75  (3.05) 35.37  (3.90)
Time Frame 3.75 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Verum Laser Acupuncture Sham Laser Acupuncture
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Verum Laser Acupuncture Sham Laser Acupuncture
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Verum Laser Acupuncture Sham Laser Acupuncture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Verum Laser Acupuncture Sham Laser Acupuncture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wen-Long Hu
Organization: Kaohsiung Chang Gung Memorial Hospital
Phone: +886-7-731-7123 ext 2334
EMail: oolonghu@gmail.com
Layout table for additonal information
Responsible Party: Wen-Long Hu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02840916     History of Changes
Other Study ID Numbers: CMRPG8C0691
First Submitted: July 14, 2016
First Posted: July 21, 2016
Results First Submitted: July 23, 2016
Results First Posted: January 16, 2017
Last Update Posted: January 16, 2017