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Completed

NCT Number: NCT02840916

Laser Acupuncture for Postpartum Weight Retention

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.

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Key information

Conditions

Postpartum Weight Retention Body Weight Body Weight Changes Gestational Weight Gain Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: low-level laser therapy

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.

Primary outcomes

  1. Body Mass Index (BMI)

    Time frame: 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 outcomes

  1. Waist-to-buttock Ratio (WBR)

    Time frame: 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.

  2. Body Fat Percentage (BFP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2016
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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