NCT02167308

Brief Summary

Background: Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded, or included low-calorie diet control. Investigators have therefore designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity. Methods/design: One hundred and four subjects above 20 years of age with a body mass index (BMI) of over 25 kg/m2 will be divided into two groups: experimental and control. Each subject will receive the treatment relevant to their group three times a week for eight weeks. After eight weeks of treatment the subject will enter a two week washout period, after which the subjects will switch groups. Measurements will include BMI, body fat percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh circumference, body fat, blood pressure, heart rate, hunger, and the 36-item short-form health survey (SF-36). Discussion: The results of this pilot study will provide the basis for future large-scale multicenter trials investigating the effects of laser acupuncture on obesity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

June 14, 2014

Last Update Submit

June 17, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI change from baseline

    week 26

Secondary Outcomes (4)

  • Body fat percentage

    week 26

  • Waist-to-Hip ratio (WHR)

    week 26

  • Hunger

    week 26

  • Quality of life

    week 26

Other Outcomes (4)

  • Skin fold thickness

    week 26

  • Thigh circumference

    week 26

  • Blood pressure

    week 26

  • +1 more other outcomes

Study Arms (2)

Laser acupuncture group

ACTIVE COMPARATOR

Subjects will receive 24 activated laser acupuncture treatments. The laser will be applied for 10 seconds to each of the selected acupuncture points.

Device: Laser acupuncture

Control group

SHAM COMPARATOR

Subjects in the control group will undergo sham laser acupuncture treatment with no laser power output. Acupuncture points, application duration, and total number of treatments will be identical to the Laser acupuncture group.

Device: Laser acupuncture

Interventions

Laser acupunctureDEVICE

a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.

Control groupLaser acupuncture group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals are eligible if they are above 20 years of age and have a BMI over 25 kg/m2. BMI cutoffs were adopted from a proposed classification of weight by BMI in adult Asians, including the obese I (BMI: 25-29.9 kg/m2) and obese II (BMI ≥30 kg/m2) categories.

You may not qualify if:

  • cardiovascular disease
  • diabetes
  • endocrine abnormalities
  • renal disease
  • contagious skin condition
  • epilepsy
  • tumor
  • mental disorder
  • pregnant
  • photosensitivity reactions to laser treatment
  • uses a pacemaker
  • used medications known to affect one's weight up to one month in advance
  • un-willing to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Chiayi County, 61363, Taiwan

RECRUITING

Related Publications (1)

  • Tseng CC, Tseng A, Chang CH. Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial. Trials. 2015 May 15;16:217. doi: 10.1186/s13063-015-0748-4.

    PMID: 25972018DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chi-Chuan Tseng, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Chuan Tseng, MD

CONTACT

+886975353410acupmox@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 14, 2014

First Posted

June 19, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

TW(1)