Postpartum Weight RetentionPhase 3NCT02840916
Laser Acupuncture for Postpartum Weight Retention
A Phase 3 study testing laser acupuncture in people with Postpartum Weight Retention, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Weight Retention
- What is being tested?
- laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Postpartum Weight Retention
- Being tested
- laser acupuncture, sham laser acupuncture
- Keywords
- Laser acupuncture, Postpartum weight retention, Obesity
- Medical subject headings
- Gestational Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser acupunctureProcedure or surgery
Also called low-level laser therapy
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 acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| verum laser acupuncture | Experimental | verum laser acupuncture Receives: Procedure: laser acupuncture |
| sham laser acupuncture | Sham comparator | sham laser acupuncture (no laser output) Receives: Procedure: sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 weeks, 3 months after study completion
Secondary outcomes (2)
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.
Measured: up to 3 weeks
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.
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Weight RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Long Hu, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840916
- Sponsor's protocol ID
- CMRPG8C0691
- Status last verified
- Nov 2016
- First submitted
- 14 Jul 2016
- Last updated
- 16 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20821818
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Therapy in Patients With Postpartum Weight Retention: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02840916
- Acronym / sponsor ID
- CMRPG8C0691
- Conditions
- Postpartum Weight Retention
- Keywords
- Laser acupuncture, Postpartum weight retention, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Posted 16 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum laser acupuncture | Experimental | Procedure: laser acupunctureverum laser acupuncture |
| sham laser acupuncture | Sham comparator | Procedure: sham laser acupuncturesham laser acupuncture (no laser output) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- presence of a pacemaker;
- history of seizure or epilepsy;
- taking immunosuppressant medication;
- cancer;
- infectious disease of the skin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser acupunctureAlso: low-level laser therapySubjects 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. | Procedure or surgery | verum laser acupuncture |
| sham laser acupunctureSubjects 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. | Procedure or surgery | sham laser acupuncture |
Primary outcome
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.
2 secondary outcomes
Waist-to-buttock Ratio (WBR)
Time frame: up to 3 weeks
Body Fat Percentage (BFP)
Time frame: up to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20821818Hu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing laser acupuncture in people with Postpartum Weight Retention, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: up to 3 weeks, 3 months after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.