
==== Front
BMJ Open
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BMJ Open
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BMJ Publishing Group BMA House, Tavistock Square, London, WC1H 9JR

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10.1136/bmjopen-2023-083158
bmjopen-2023-083158
Protocol
Complementary Medicine
1685
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Acupuncture for obesity：study protocol for a randomised controlled trial
http://orcid.org/0000-0001-7438-1254
Zhao Xinyu 10zhaoxinyu@stu.cdutcm.edu.cn

http://orcid.org/0000-0002-4920-6515
Wang Yang 230wangyang@cdsu.edu.cn

Li Xiaoyi 12678862699@qq.com

Wu Nianwei 45804334553@qq.com

Zhang Shanshan 41156791485@qq.com

Wu Shiyi 4m13091880945@163.com

Hu Peiqun 22548322126@qq.com

Chen Ximei 2416411837@qq.com

Zhou Lei 62796763060@qq.com

Wei Aiming 6weiaiming17@163.com

Pan Chongsheng 61398921843@qq.com

Liu Yunlu 7kaela85@qq.com

He Benxiang 8100539@cdsu.edu.cn

Hu Yushi 2huyushi@cdsu.edu.cn

http://orcid.org/0000-0002-1257-3899
Zhu Tianmin 6*tmzhu@hotmail.com

http://orcid.org/0000-0002-9350-9230
Pan Xiong-Fei 459*pxiongfei@scu.edu.cn

1 School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
2 School of Sports Medicine and Health, Chengdu Sport University, Chengdu, Sichuan, China
3 Postdoctoral Workstation, Affiliated Sport Hospital of Chengdu Sport University, Chengdu, Sichuan, China
4 Section of Epidemiology and Population Health & Department of Gynecology and Obstetrics, Ministry of Education Key Laboratory of Birth Defects and Related Diseases of Women and Children & National Medical Products Administration Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China
5 West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China
6 School of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
7 Institute of Laboratory Animal Sciences, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
8 Sichuan Academy of Chinese Medicine Sciences, Chengdu, Sichuan, China
9 Shuangliu Institute of Women’s and Children’s Health, Shuangliu Maternal and Child Health Hospital, Chengdu, Sichuan, China
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

None declared.

ProfessorXiong-FeiPan; pxiongfei@scu.edu.cn
ProfessorTianminZhu; tmzhu@hotmail.com
XZ and YW contributed equally.

2024
26 8 2024
14 8 e08315813 12 2023
26 7 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Abstract

Background

Obesity is a major public health issue in China and around the world. While acupuncture is often used in clinical practice, there is a lack of conclusive evidence for its weight-loss effect. Thus we will conduct a parallel, randomised, sham-controlled trial to evaluate the efficacy and safety of acupuncture for treating obesity.

Methods and analysis

A total of 160 eligible participants with obesity will be randomly assigned to the verum acupuncture group or sham acupuncture group at a ratio of 1:1. All participants will be treated three times a week for a duration of 12 weeks, and followed up for another 16 weeks. The primary outcome is the percentage change in body weight from baseline to Week 12. The secondary outcomes include body mass index (BMI), waist circumference (WC), body fat percentage (BF%), blood pressure, fasting blood glucose, insulin, glycosylated haemoglobin A1c, blood lipids, and physical functioning score on the Short Form 36 Health Survey. Other secondary outcomes including psychological and social functions will also be evaluated using the body image scale, psychological function scale, and social function scale of the BODY-Q, Rosenberg Self-Esteem Scale, Patient Health Questionnaire-9, and Dutch Eating Behaviour Questionnaire. BMI, WC, BF% and blood pressure will be evaluated at Week 0, 4, 8, 12 and 28. Other secondary outcomes will be measured at Week 0, 12 and 28, respectively. Adverse events will be recorded in detail during the trial.

Ethics and dissemination

Ethical approval of this trial was granted by the Ethics Committee of Chengdu Sport University (2023–102). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2200062092).

Obesity
Clinical Trial
COMPLEMENTARY MEDICINE
Scientific and Technological Innovation Project of the General Administration of Sport of China 22KJCX009 http://dx.doi.org/10.13039/501100018542 Natural Science Foundation of Sichuan Province 2022NSFSC1529 2024NSFSC0578 Fund of Key Laboratory for Sports Medicine of Sichuan Province & General Administration of Sport 2023-A055 Fundamental Research Funds for the Central Universities YJ202346 Innovation Project of Key Laboratory for Sports Medicine of Sichuan Province & General Administration of Sport SCZJJCC 02 High-level Talents Program of Chengdu Sport University D400828 The funding agencies has no role in the design, implementation, data analysis and manuscript writing of the trial.
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pmcSTRENGTHS AND LIMITATIONS OF THIS STUDY

This is a large parallel, randomised, sham-controlled trial to evaluate the efficacy and safety of acupuncture for obesity in China.

Psychological and social functions will be evaluated in addition to physiological measures to confirm the therapeutic effects of acupuncture.

The 12-week treatment and an ensuing 16-week follow-up will allow us to understand the long-term effects of acupuncture.

The long duration of the trial may compromise the participants’ compliance.

The generalisability may be limited as all participants will be recruited from Chengdu, China.

Introduction

Obesity is defined as abnormal or excessive fat accumulation that is potentially harmful to health. Nearly 880 million adults and 159 million children and adolescents are living with obesity globally.1 In China, the prevalence is approximately 34.3% for overweight and 16.4% for obesity in adults.2 Obesity is not only a chronic metabolic disease but also an independent risk factor for multiple non-communicable diseases, such as cardiovascular disease and type 2 diabetes mellitus, and psychosocial and social impairments.3 The management of obesity is crucial for addressing the burden of non-communicable diseases.

Several treatments are advised for obesity. Behavioural interventions, including diet changes and physical activities, are regarded as the first-line treatment for reducing body weight. However, the effect of behavioural interventions is weak and slow; at least 6 months is needed to achieve significant improvement.4 5 Pharmacotherapy is commonly used in the USA and Europe, but most weight-loss medications have adverse effects of varying degrees, such as headache, nausea, insomnia and diarrhoea.6 7 While bariatric surgery has long-term positive effects on weight loss with evident cardiovascular benefits, it is mostly recommended for severe obesity. Thus, the identification of safe, effective and low-cost therapies for obesity is still imperative.

Emerging evidence points to the potential weight-loss effects of acupuncture as a traditional Chinese medicine therapy. In a systematic review of eight randomised controlled trials (RCTs) among 403 participants, acupuncture was reported to lead to mean reductions of 1.85 kg and 1.0 kg/m2 in body weight and body mass index (BMI), as compared with sham acupuncture.8 In addition, another systematic review of 23 trials among 1808 participants showed that acupuncture was more effective than sham acupuncture or no treatment for weight reduction, with or without lifestyle modification.9 Despite the collective evidence, there are still controversies over the efficacy of acupuncture, mainly due to a lack of high-quality data.10 The included trials generally had small sample sizes with short treatment periods and follow-ups, and in particular, the placebo effect of acupuncture could not be excluded in most cases because an appropriate placebo is not readily available. As non-penetrating acupuncture is emerging as a sham control in clinical research,11 12 it could be potentially used to remove the non-specific effect of acupuncture in trials for obesity management. While multiple lines of evidence supported the effects of acupuncture in improving psychological symptoms and social function,13 14 most trials on acupuncture for obesity only focused on physical health improvement; the effect on psychological and social functions is less examined. Based on the bio-psycho-social model, psychological and social impairments should be captured in such obesity trials.15

To address the knowledge gap, we intend to conduct an RCT with non-penetrating acupuncture at acupoints as control, to investigate the efficacy and safety of acupuncture for obesity treatment. Physiological outcomes, psychological and social functions, as well as adverse events, will be assessed in the follow-up. Our trial will be one of the most rigorous RCTs on the relation between acupuncture and weight loss, thus providing evidence for its utility for clinical weight management.

Methods and analyses

Study design

We will conduct a parallel, randomised and sham-controlled clinical trial at Chengdu Sport University and Chengdu University of Traditional Chinese Medicine. A total of 160 participants with obesity will be recruited and randomly assigned to verum acupuncture or sham acupuncture at a ratio of 1:1. Participants in the verum acupuncture group will receive normal acupuncture treatment at specific meridians and acupoints, while those in the sham acupuncture group will receive non-penetrating needling at these acupoints. All participants will receive treatment three times per week during the 12-week treatment period, and then followed up for a 16-week post-treatment period. Besides, both groups will receive lifestyle guidance (including diet and physical activity consultation) during the whole period. The flowchart of the whole trial is shown in figure 1, while the schedule is outlined in table 1. The protocol is developed under the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 201316 (online supplemental file 1) and the SPIRIT-TCM (traditional Chinese medicine) Extension 2018.17

Figure 1 Flowchart of the trial. BF%, body fat percentage; BMI, body mass index; WC, waist circumference.

Table 1 Schedule of enrolment, interventions and assessments

Timepoint	Enrolment	Baseline	Treatment period	Follow-up period	
Week -1	Week 0	Week 4 Week 8 Week 12	Week 16 Week 20 Week 24 Week 28	
Enrolment	 	
 Eligibility screening	×	 	 	 	 	 	 	 	
 Informed consent	×	 	 	 	 	 	 	 	
 Randomisation	 	×	 	 	 	 	 	 	
Interventions	 	
 Verum acupuncture group	 	 	 ×	×	×	 	 	 	
 Sham acupuncture group	 	 	 ×	×	×	 	 	 	
Assessments	 	
 Body weight	×	×	 ×	×	×	 	 	 ×	
 BMI	×	×	 ×	×	×	 	 	 ×	
 WC	 	×	 ×	×	×	 	 	 ×	
 BF%	 	×	 ×	×	×	 	 	 ×	
 Blood pressure	 	×	 ×	×	×	 	 	 ×	
 Fasting blood glucose	 	×	 	 	×	 	 	 ×	
 Insulin	 	×	 	 	×	 	 	 ×	
 HbA1c	 	×	 	 	×	 	 	 ×	
 Blood lipids	 	×	 	 	×	 	 	 ×	
 SF-36	 	×	 	 	×	 	 	 ×	
 BIS of the BODY-Q		×			×			×	
  PFS of the BODY-Q	 	×	 	 	×	 	 	 ×	
  SFS of the BODY-Q	 	×	 	 	×	 	 	 ×	
 RSES	 	×	 	 	×	 	 	 ×	
 PHQ-9	 	×	 	 	×	 	 	 ×	
 DEBQ		×			×			×	
 Adverse events	 	 	×	×	×	 ×	 ×	×	×	
 Blinding assessment	 	 	 	 	×	 	 	 	
BF%body fat percentageBISbody image scaleBMIbody mass indexDEBQDutch Eating Behavior QuestionnaireHbA1cglycosylated haemoglobin A1CPFSpsychological function scalePHQ-9Patient Health Questionnaire-9RSESRosenberg Self-Esteem ScaleSF-3636-Item Short Form Health SurveySFSsocial function scaleWCwaist circumference

Sample size estimation

Based on data from the literature,1822 we expected that the difference in the percentage of weight loss was 4% (standard deviation, 8%) between verum acupuncture and sham acupuncture groups after 12-week treatment. With the aforementioned statistics, to achieve a statistical power of 80% (1 - β=0.8) with a two-sided significance level of 0.05, 160 participants are needed (80 participants in each group) if a dropout rate of 20% is assumed. PASS software V.15.0 (Kaysville, Utah, USA) is used to calculate the sample size.

Recruitment and informed consent

Participants in the RCT are recruited through social media platforms or offline advertisements (eg, posters or leaflets) at Chengdu Sport University and Chengdu University of Traditional Chinese Medicine from June 2023 to December 2026. Adults who are eligible will be invited to participate. All participants will be given information of the research procedure and the benefits and risks of the study. Informed consent will be obtained from all participants before randomisation. Ethics approval was obtained from the Ethics Committee of Chengdu Sport University (2023–102).

Inclusion criteria

Participants will be recruited if they meet the following criteria:

BMI ≥28 kg/m2 (based on the obesity criteria in Chinese adults).2

Adults aged 18–35 years.

Having not received any weight-loss measures in the past 3 months.

Voluntarily participating in the trial and signing informed consent.

Exclusion criteria

Participants will be excluded if they meet any of the following criteria:

Secondary obesity caused by drugs or other diseases.

Psychosis, liver and kidney dysfunctions or other relevant diseases.

Skin diseases, severe allergic or scar constitution.

Pregnant or lactating women or those planning to conceive during the trial.

Having participated in other clinical trials.

Randomisation and allocation concealment

After enrolment, participants will be randomised into the treatment or control group by research personnel who are not involved in the treatment or data collection but are familiar with administrative work. Stata software V.17.0 will be used to generate random numbers and serial numbers, which are sealed in opaque paper envelopes. All participants allotted with specific serial numbers will be randomly assigned to verum acupuncture or sham acupuncture according to the random numbers.

Blinding

The study is a single-blinded trial, in which participants remain unknown about the group assignment throughout the study. Recruiters, acupuncturists, data collectors, outcome evaluators and data managers will work independently throughout the study. Only the acupuncturists know the grouping details. Participants will wear opaque eye masks during the treatment. To evaluate the quality of blinding, participants will be asked to answer a question after treatment at Week 12: which acupuncture do you think you have received? The participants will be provided with two options to answer this question: verum acupuncture or sham acupuncture.

Intervention

All participants will receive verum acupuncture or sham acupuncture every other day, three times per week for 12 weeks (4 weeks per session). Treatment will be performed by licensed acupuncturists, who receive standard training in advance. A stick adhesive pad will be placed on each acupoint before acupuncture administration, through which the needles are/are not inserted into the skin (figure 2). During treatment, two groups of participants will be treated in separate rooms and asked to wear an opaque eye mask. Besides, all participants will receive lifestyle guidance for diet control, physical activity and sufficient sleep at baseline (Week 0), and Week 4, 8 and 12.

Figure 2 Diagram of verum acupuncture versus sham acupuncture.

Verum acupuncture

Based on the traditional Chinese medicine theory and literature,23 24 CV4 (Guanyuan), CV6 (Qihai), CV12 (Zhongwan), bilateral SP6 (Sanyinjiao), SP9 (Yinlingquan), SP15 (Daheng), ST25 (Tianshu), ST36 (Zusanli) and ST40 (Fenglong) are included in the acupuncture prescription, the locations of which are presented in figure 3. The depths of needle insertion are shown in table 2.

Figure 3 Locations of acupoints. (A) abdomen; (B) front side of right leg; (C) inner side of right leg.

Table 2 Acupoints used in the treatment

Acupoints	Locations*	Depth of insertion	
CV4(Guanyuan)	On the lower abdomen, anterior median line, 3 cun below the navel	1.0–1.5 cun	
CV6(Qihai)	On the lower abdomen, anterior median line, 1.5 cun below the navel	1.0–1.5 cun	
CV12(Zhongwan)	On the upper abdomen, anterior median line, 4 cun above the navel	1.0–1.5 cun	
SP6(Sanyinjiao)	On the inner side of the calf, 3 cun above the tip of the medial malleolus, by the posterior border of the tibia	1.0–1.5 cun	
SP9(Yinlingquan)	On the inner side of the calf, in the depression between the inferior border of the medial condyle of the tibia and the medial border of the tibia	1.0–1.5 cun	
SP15(Daheng)	On the abdomen, 4 cun beside the navel	1.0–1.5 cun	
ST25(Tianshu)	On the abdomen, horizontal to the umbilicus, 2 cun lateral to the anterior midline	1.0–1.5 cun	
ST36(Zusanli)	On the anterior lateral side of the calf, 3 cun below Dubi (ST35)†, one horizontally placed finger distance lateral to the anterior border of the tibia (the middle finger)	1.0–1.5 cun	
ST40(Fenglong)	Outside the calf, 8 cun above the tip of the lateral malleolus, the outer border of the tibialis anterior muscle	1.0–1.5 cun	
* The cun is a measure of length in traditional Chinese medicine. 1 cun (≈20 mm) is defined as the width of the interphalangeal joint of patient’s thumb.

† ST35 is located on the lateral depression of the patellar ligament.

After sterilisation, acupuncturists will use stainless steel needles (0.30×40 mm, Hwato, Suzhou, China) to penetrate the skin and insert them into acupoints at different depths through the stick adhesive pad. Afterwards, the needles will be manipulated by twirling, lifting and thrusting to generate the sensation of de qi, which is a complicated feeling of mixed numbness, heaviness and distension. Electrical stimulation will be applied using an electronic acupunctoscope (SDZ-III Suzhou Medical Appliance Factory, China) for 30 min. One pair of electrodes will connect acupoint ST25 to SP15, while another pair will connect ST36 to ST40. The power source offers a disperse-dense wave, which we ensure that all participants can tolerate.

Sham acupuncture

The selected acupoints are the same as those for the verum acupuncture group. After sterilisation, non-invasive acupuncture needles with blunt tips (0.30×40 mm, Hwato, Suzhou, China) will be used to penetrate the sterile stick adhesive pad but not into the skin, so a de qi sensation is not achieved. In addition, the acupoints will be connected to an electronic acupunctoscope but no electrical stimulation will be provided.

Outcomes

Outcome assessors will independently measure the outcomes for the two groups of participants.

Primary outcome

The primary outcome is the percentage change in body weight from baseline to Week 12.

Secondary outcomes

Extensive effects of acupuncture on obesity, including psychological and social functions will be assessed in addition to physiological outcomes.

Physiological outcomes include BMI, waist circumference (WC), body fat percentage (BF%), blood pressure, fasting blood glucose, insulin, glycosylated haemoglobin A1c, blood lipids, and physical functioning score on the Short Form 36 Health Survey.25

Psychological and social functions will be evaluated using the body image scale, psychological function scale, and social function scale of the BODY-Q, 26 Rosenberg Self-Esteem Scale,27 Patient Health Questionnaire-9,28 and Dutch Eating Behaviour Questionnaire.29

For these outcomes, BMI, WC, BF% and blood pressure will be evaluated at Week 0, 4, 8, 12 and 28. Other secondary outcomes will be measured at Week 0, 12 and 28, respectively.

Safety outcomes

Acupuncture-related adverse events including serious pain, bleeding, subcutaneous haemorrhage, fainting, palpitation, and local infections will be recorded after each 4-week acupuncture session. All adverse events that occur during the study will be properly handled. In case of serious adverse events (SAEs), research personnel shall take all necessary measures to ensure patient safety. Treatment costs and corresponding financial compensations for these SAEs will be covered by the trial. SAEs should be reported within 24 hours to the research ethics committee, which has the right to terminate the trial if necessary.

Quality control

Prior to participant recruitment, standard operation procedures (SOPs) will be established. All research personnel will receive SOP training to understand the design, implementation and regulations of this study. A data monitoring plan will also be developed. Quality assurance monitors will check all research documents for completeness and compliance with SOPs. The Ethics Committee of Chengdu Sport University will regularly arrange quality control inspections.

Statistical analysis

Data from the trial will be managed and monitored by specific data managers. Intention-to-treat analyses will be used to evaluate all outcome measures, for which the analysis set is composed of all randomised participants. Missing data will be imputed using the last observation-carried-forward method. Continuous data will be reported as mean and standard deviation if they meet the normal distribution; otherwise, they will be presented as median and interquartile range. Categorical variables will be expressed in terms of frequency and percentage. For demographic and clinical information at baseline, χ2 test or Fisher’s exact test will be used to compare categorical data, while two-sample t-test or Mann-Whitney U test will be used for continuous data. To compare changes within a group, paired t-test or Wilcoxon signed-rank test will be used. Net differences in mean weight (or BMI) changes between the verum acupuncture group and sham acupuncture group will be tested using a linear mixed effects model. Subgroup analyses will be performed by stratifying variables including sex (male and female), baseline BMI (28–29.9 kg/m2, 30–31.9 kg/m2 and ≥32 kg/m2) and family history of obesity (yes and no). Interactions between verum acupuncture and stratifying variables will be assessed using a likelihood-ratio test. A p<0.05 is considered statistically significant. All data will be analysed using Stata V.17.0 (StataCorp LLC).

Patient and public involvement

Patients and/or the public will not be involved in the design, conduct, reporting or dissemination plans of this research.

Discussion

Acupuncture is increasingly used in clinical practice for obesity treatment. Although the collective evidence indicates a potential weight-loss effect from acupuncture, such evidence is weak due to methodological and statistical weaknesses, such as small sample sizes and short treatment durations and follow-ups.2 8 Our study is conducted in such a context to consolidate the effect of acupuncture on obesity in the adult population.

Our trial will recruit 160 participants who will undergo a 12-week treatment and 16-week post-treatment follow-up. Previous trials on this topic included 30–70 participants in most cases.8 30 31 Our larger trial will improve the statistical power to identify the potential weight-loss effect. Weight regain is always a concern for weight-loss interventions, so a long-term follow-up is necessary to assess this regain in participants who receive acupuncture. Our trial has a longer follow-up than any others (4–12 weeks) on weight control through acupuncture as identified in the literature.10 22 24 32 The long follow-up with repeated observations of body weight in our work will help us to understand the long-term effects of acupuncture on obesity, particularly the weight dynamics after treatment. Moreover, the effect of acupuncture on obesity is mostly only assessed in terms of weight loss or BMI in other trials, which could be problematic as acupuncture itself has multiple effects on health such as improvement in psychological and social functions. To our knowledge, our trial will be one of the first ones to include these outcomes as secondary endpoints in participants with obesity. Although many adults with obesity could have psychological and social dysfunctions, these dysfunctions are often ignored in trials on obesity. Our trial can comprehensively assess the effect of acupuncture in the framework of a bio-psycho-social model for obesity. Moreover, the use of sham acupuncture as the control and the use of lifestyle guidance in both groups make it possible to differentiate the specific from non-specific effects of acupuncture, which is rarely addressed in other trials.

We acknowledge certain limitations in our trial. First, study participants will be primarily enrolled from university students in Chengdu, China. This participant composition may affect the generalisability of our findings. However, we believe that such enrolment could increase compliance. Second, as the follow-up is 16 weeks long after treatment, selection and information bias due to loss to follow-up could be expected. We plan to use various strategies such as close contact with participants through social media to improve the follow-up rate. Third, acupoints and electrostimulation are standardised for all participants without considerations of participant characteristics in our trial. Such an arrangement facilitates the implementation of the trial but may miss the chance of evaluating tailored treatments that are applied in clinical practice. Fourth, it is likely that some participants have received acupuncture for obesity or other conditions before, which may affect the effect of the blinding procedure in the trial. However, as most study participants will be university students, they are expected to receive acupuncture treatment for the first time.

Our large trial with a long follow-up and comprehensive assessments of endpoints will improve the current evidence base for the weight-loss effect of acupuncture. Our findings may contribute to the use of acupuncture for obesity management and control in clinical practice.

Ethics and dissemination

This study was approved by the Ethics Committee of Chengdu Sport University (2023–102) on 30 May 2023 and conformed to the Declaration of Helsinki. Registration was completed on 11 June 2023, in the Chinese Clinical Trial Registry (ChiCTR2200062092). All participants must provide written informed consent before participating in the trial (online supplemental material 2). All personal information from potential and enrolled participants out of the scope of this trial will not be collected, shared or maintained to protect confidentiality before, during and after the trial. Trial results will be published in peer-reviewed journals and will be disseminated to the media and the public.

supplementary material

10.1136/bmjopen-2023-083158 online supplemental file 1

10.1136/bmjopen-2023-083158 online supplemental file 2

Acknowledgements

We acknowledge all study personnel and participants for their contributions to this work.

Review Process File
26 08 2024

Funding: This study was supported by the Fund of Key Laboratory for Sports Medicine of Sichuan Province & General Administration of Sport (2023-A055), the Innovation Project of Key Laboratory for Sports Medicine of Sichuan Province & General Administration of Sport (SCZJJCC 02), the Natural Science Foundation of Sichuan Province (2022NSFSC1529), the Scientific and Technological Innovation Project of the General Administration of Sport of China (22KJCX009), and the High-level Talents Program of Chengdu Sport University (D400828). Xiong-Fei Pan was supported by the Fundamental Research Funds for the Central Universities (YJ202346) and Natural Science Foundation of Sichuan Province (2024NSFSC0578).

prepub: Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2023-083158).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.
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References

1 NCD Risk Factor Collaboration (NCD-RisC) Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults Lancet 2024 403 1027 50 38432237
2 Pan XF Wang L Pan A Epidemiology and determinants of obesity in China Lancet Diabetes Endocrinol 2021 9 373 92 10.1016/S2213-8587(21)00045-0B1 34022156
3 Blüher M Obesity: global epidemiology and pathogenesis Nat Rev Endocrinol 2019 15 288 98 10.1038/s41574-019-0176-8B1 30814686
4 Dombrowski SU Avenell A Sniehott FF Behavioural interventions for obese adults with additional risk factors for morbidity: systematic review of effects on behaviour, weight and disease risk factors Obes Facts 2010 3 377 96 10.1159/000323076B3 21196792
5 Kesztyüs D Erhardt J Schönsteiner D et al Therapeutic treatment for abdominal obesity in adults Dtsch Arztebl Int 2018 115 487 93 10.3238/arztebl.2018.0487B2 30135008
6 Zhou Y-M Yan B Yuan W-Q et al Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: study protocol for a randomized controlled trial Trials 2019 20 644 10.1186/s13063-019-3730-8B4 31775839
7 Zeng Q Li N Pan X-F et al Clinical management and treatment of obesity in China Lancet Diabetes Endocrinol 2021 9 393 405 10.1016/S2213-8587(21)00047-4B1 34022157
8 Zhong Y-M Luo X-C Chen Y et al Acupuncture versus sham acupuncture for simple obesity: a systematic review and meta-analysis Postgrad Med J 2020 96 221 7 10.1136/postgradmedj-2019-137221B4 32015189
9 Fang S Wang M Zheng Y et al Acupuncture and lifestyle modification treatment for obesity: a meta-analysis Am J Chin Med 2017 45 239 54 10.1142/S0192415X1750015XB2 28231746
10 Chen J Chen D Ren Q et al Acupuncture and related techniques for obesity and cardiovascular risk factors: a systematic review and meta-regression analysis Acupunct Med 2020 38 227 34 10.1136/acupmed-2018-011646B3 32310001
11 Napadow V Dhond RP Kim J et al Brain encoding of acupuncture sensation--coupling on-line rating with fMRI Neuroimage 2009 47 1055 65 10.1016/j.neuroimage.2009.05.079B2 19500677
12 Pirotta M Ee C Teede H et al Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial Trials 2014 15 224 10.1186/1745-6215-15-224B4 24925094
13 Fan L Fu W Chen Z et al Curative effect of acupuncture on quality of life in patient with depression: a clinical randomized single-blind placebo-controlled study J Tradit Chin Med 2016 36 151 9 10.1016/s0254-6272(16)30021-8B4 27400468
14 Wang Y Qin Y Li H et al The modulation of reward and habit systems by acupuncture in adolescents with Internet addiction Neural Plast 2020 2020 7409417 10.1155/2020/7409417B4 32256558
15 Puzhko S Schuster T Barnett TA et al Evaluating prevalence and patterns of prescribing medications for depression for patients with obesity using large primary care data (Canadian Primary Care Sentinel Surveillance Network) Front Nutr 2020 7 24 10.3389/fnut.2020.00024B2 32258046
16 Chan A-W Tetzlaff JM Altman DG et al SPIRIT 2013 statement: defining standard protocol items for clinical trials Ann Intern Med 2013 158 200 7 10.7326/0003-4819-158-3-201302050-00583 23295957
17 Dai L Cheng C-W Tian R et al Standard protocol items for clinical trials with traditional Chinese medicine 2018: recommendations, explanation and elaboration (SPIRIT-TCM Extension 2018) Chin J Integr Med 2019 25 71 9 10.1007/s11655-018-2999-xB3 30484022
18 Mok MS Parker LN Voina S et al Treatment of obesity by acupuncture Am J Clin Nutr 1976 29 832 5 10.1093/ajcn/29.8.832B1 941864
19 Firouzjaei A Li G-C Wang N et al Comparative evaluation of the therapeutic effect of metformin monotherapy with metformin and acupuncture combined therapy on weight loss and insulin sensitivity in diabetic patients Nutr Diabetes 2016 6 e209 10.1038/nutd.2016.16B2 27136447
20 Han M Sun Y Su W et al The efficacy of acupuncture on anthropometric measures and the biochemical markers for metabolic syndrome: a randomized controlled pilot study Evid Based Complement Alternat Med 2017 2017 8598210 10.1155/2017/8598210 29234438
21 Xie X-C Cao Y-Q Gao Q et al Acupuncture improves intestinal absorption of iron in iron-deficient obese patients: a randomized controlled preliminary trial Chin Med J (Engl) 2017 130 508 15 10.4103/0366-6999.200549B3 28229980
22 Dai L Wang M Zhang K-P et al Modified acupuncture therapy, long-term acupoint stimulation versus sham control for weight control: a multicenter, randomized controlled trial Front Endocrinol (Lausanne) 2022 13 952373 10.3389/fendo.2022.952373B2 35966092
23 Güçel F Bahar B Demirtas C et al Influence of acupuncture on leptin, ghrelin, insulin and cholecystokinin in obese women: a randomised, sham-controlled preliminary trial Acupunct Med 2012 30 203 7 10.1136/acupmed-2012-010127B3 22729015
24 Zhong LLD Kun W Lam TF et al 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 17 346 10.1186/s13063-016-1458-2B4 27457720
25 Brazier JE Harper R Jones NM Validating the SF-36 health survey questionnaire: new outcome measure for primary care BMJ 1992 305 160 4 10.1136/bmj.305.6846.160 1285753
26 Poulsen L McEvenue G Klassen A et al Patient-reported outcome measures: BODY-Q Clin Plast Surg 2019 46 15 24 10.1016/j.cps.2018.08.003B3 30447824
27 McKay MT Boduszek D Harvey SA The Rosenberg Self-Esteem Scale: a bifactor answer to a two-factor question? J Pers Assess 2014 96 654 60 10.1080/00223891.2014.923436B3 24940657
28 Kroenke K Spitzer RL Williams JB The PHQ-9: validity of a brief depression severity measure J Gen Intern Med 2001 16 606 13 10.1046/j.1525-1497.2001.016009606.xB2 11556941
29 Strien TV Frijters JER Bergers GPA et al The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior 1986 5 295 315
30 Gao Y Wang Y Zhou J et al Effectiveness of Electroacupuncture for Simple Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Evid Based Complement Alternat Med 2020 2020 2367610 2367610 10.1155/2020/2367610 32714399
31 Teng J Chen J Yu X et al Electroacupuncture for obesity: A systematic review and meta-analysis Asian J Surg 2023 46 4844 5 10.1016/j.asjsur.2023.05.130B3 37316344
32 Schukro RP Heiserer C Michalek-Sauberer A et al The effects of auricular electroacupuncture on obesity in female patients – A prospective randomized placebo-controlled pilot study Complement Ther Med 2014 22 21 5 10.1016/j.ctim.2013.10.002B3 24559812
