Postpartum Weight Retention
Conditions
Keywords
Laser acupuncture, Postpartum weight retention, Obesity
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.
Interventions
PROCEDURElaser 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.
PROCEDUREsham 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist-to-buttock Ratio (WBR) | 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) | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 30 |
| Total | 62 |
Baseline characteristics
| Characteristic | Sham Laser Acupuncture | Verum Laser Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 32 Participants | 62 Participants |
| Age, Continuous | 35.70 years STANDARD_DEVIATION 3.72 | 34.88 years STANDARD_DEVIATION 4.31 | 35.28 years STANDARD_DEVIATION 4.02 |
| Gender Female | 30 Participants | 32 Participants | 62 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 30 participants | 32 participants | 62 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
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.
Time frame: up to 3 weeks, 3 months after study completion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verum Laser Acupuncture | Body Mass Index (BMI) | baseline | 33.62 kg/m^2 | Standard Deviation 3.19 |
| Verum Laser Acupuncture | Body Mass Index (BMI) | up to 3 weeks | 26.90 kg/m^2 | Standard Deviation 2.29 |
| Verum Laser Acupuncture | Body Mass Index (BMI) | 3 months after study completion | 26.16 kg/m^2 | Standard Deviation 2.4 |
| Sham Laser Acupuncture | Body Mass Index (BMI) | baseline | 28.03 kg/m^2 | Standard Deviation 3.04 |
| Sham Laser Acupuncture | Body Mass Index (BMI) | up to 3 weeks | 26.99 kg/m^2 | Standard Deviation 3.45 |
| Sham Laser Acupuncture | Body Mass Index (BMI) | 3 months after study completion | 26.64 kg/m^2 | Standard Deviation 3.4 |
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.
Time frame: up to 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verum Laser Acupuncture | Body Fat Percentage (BFP) | baseline | 36.94 % of body weight | Standard Deviation 2.65 |
| Verum Laser Acupuncture | Body Fat Percentage (BFP) | up to 3 weeks | 35.75 % of body weight | Standard Deviation 3.05 |
| Sham Laser Acupuncture | Body Fat Percentage (BFP) | baseline | 36.02 % of body weight | Standard Deviation 3.87 |
| Sham Laser Acupuncture | Body Fat Percentage (BFP) | up to 3 weeks | 35.37 % of body weight | Standard Deviation 3.9 |
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.
Time frame: up to 3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Verum Laser Acupuncture | Waist-to-buttock Ratio (WBR) | baseline | 0.93 ratio | Standard Deviation 0.06 |
| Verum Laser Acupuncture | Waist-to-buttock Ratio (WBR) | up to 3 weeks | 0.92 ratio | Standard Deviation 0.05 |
| Sham Laser Acupuncture | Waist-to-buttock Ratio (WBR) | baseline | 0.92 ratio | Standard Deviation 0.06 |
| Sham Laser Acupuncture | Waist-to-buttock Ratio (WBR) | up to 3 weeks | 0.90 ratio | Standard Deviation 0.05 |