Clinical trial NCT02516878: Acupuncture for Body Weight Control
Official title: Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: acupuncture
Chinese Medicine
obesity
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in Hong Kong.

Detailed description: This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65 years old;
* body mass index (BMI)≥25 kg/m2;
* having not received any other weight control measures or any medical and/or drug history within the last 3 months.

Exclusion Criteria:

* endocrine diseases;
* heart diseases;
* patients with pacemaker;
* allergy and immunology diseases;
* having bleeding tendency;
* pregnant or lactating women;
* having impaired hepatic or renal function;
* stroke or otherwise unable to exercise.

Primary outcomes:
measure: Change in body weight during treatment and follow up
timeFrame: The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up
Secondary outcomes:
measure: Change in Body Mass Index (BMI) during treatment and follow up
timeFrame: The change in BMI will be assessed every two weeks during 8-week treatment and 8-week follow up
measure: Change in waist circumference during treatment and follow up
timeFrame: The change in waist circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
measure: Change in hip circumference
timeFrame: The change in hip circumference will be assessed every two weeks during 8-week treatment and 8-week follow up
measure: Change in body fat percentage during treatment and follow up
timeFrame: The change in body fat percentage will be assessed every two weeks during 8-week treatment and 8-week follow up
measure: Number of patients with adverse events after treatment
timeFrame: Number of patients with adverse events after treatment will be recorded and compared among the two groups during 8-week treatment and 8-week follow up
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Baptist University
name: Zhaoxiang Bian, MD., Ph.D
role: STUDY_DIRECTOR
References:
citation: Zhong LL, Kun W, Lam TF, Zhang SP, Yang JJ, Ziea TC, Ng B, Bian ZX. The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):346. doi: 10.1186/s13063-016-1458-2.