ObesityNCT05237089
Effect of Electroacupuncture on Obesity
A study testing Electroacupuncture and Health education in people with Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Electroacupuncture and Health education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18-65;
- Participant whose BMI is ≥24.0 kg/m2;
- Participants whose HbA1c measurement of 5.7-6.4% both inclusive, or fasting plasma glucose measurement ≥ 6.1 mmol/liter and <7.0 mmol/liter, or 2-hour plasma glucose measurement post-challenge (oral glucose tolerance test) ≥7.8 mmol/liter and <11.1 mmol/liter;
- Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg;
- Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
Who cannot join
- Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism);
- Patients who have been diagnosed with type I or type II diabetes;
- Patients who are taking medication which cause clinically significant weight gain or loss;
- Patients whose Hamilton 17-item Depression Scale (HAMD-17) score >18 or have a history of other severe psychiatric disorders;
- Patients with severe ulcer, abscess and skin infection at the local acupuncture area;
- Patients with severe diseases of multiple organs, such as heart, brain, lungs, liver, kidneys, hematopoietic system or other serious diseases;
- Participants who have joined in other clinical trials or studies within the past 1 month;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
Ziliang Wang, PhD, 021-56639828
About this study
Official title: Effects of Electroacupuncture on Weight Loss in Obese Patients With Prediabetes: a Randomized Controlled Trial
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes.
Read the detailed description
Obesity has emerged as a contributing factor in diabetes mellitus. In 2015, about 4 million deaths worldwide were directly related to high BMI, accounting for 7.1% of all deaths; among them, 41% died due to cardiovascular disease, followed by diabetes mellitus. China has become the country with the largest number of obese people and diabetic patients in the world. According to the clinical practice guidelines for medical care of obese patients announced by AACE and ACE, obese patients with prediabetes can effectively prevent the development of diabetes by lose 10% or more than of their body weight. Acupuncture is a widely recognized therapy to lose weight in clinical practice. But there are some doubts about the effectiveness of acupuncture versus sham acupuncture in treating obesity due to its lack of medical evidence.
This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of Electroacupuncture (EA) in obese patients with prediabetes. The investigators designed a protocol for a randomized controlled trial, in which 256 eligible patients will be randomly assigned to one of the two groups in a ratio of 1:1, the EA group (receiving EA treatment with health education) and the sham electroacupuncture (SA) group (receiving superficial acupuncture treatment with health education). A total of 56 sessions of interventions will be given for consecutive 24 weeks, followed by a 24-week follow-up period. Each session of EA or SA treatment will last for about 30 minutes. The primary outcome is the proportion of patients who lost 10% or more than of their body weight at week 24. The secondary outcomes include the change of patient's body weight and body mass index (BMI), results from the blood tests (FBG, 2hPG, HbA1c, HOMA-IR, LDL-C, HDL-C, TG and TC, ect.), the fat tissue size scanned by abdominal magnetic resonance imaging (MRI), data collected from the body composition analyzer, the and scores of the impact of weight on quality of life (IWQOL-Lite), Three Factor Eating Questionnaire - R21 (TFEQ-R21) and Food Cravings Questionnaire-Trait (FCQ-T). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS) from baseline to the follow-up period. The body weight and BMI will be calculated at baseline, week 8, week 16, week 24, week 32, week 40 and week 48, as well as the IWQOL-Lite, the TFEQ-R21 and the FCQ-T. Blood tests will be analyzed at baseline and week 24, as well as the body composition analyzer and the MRI scan. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 24-week intervention period.
All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary analysis will be a comparison of the proportion of patients who losing 10% or more than of their body weight between the two groups at 24 weeks after inclusion (comparison of the primary endpoint). Linear mixed-effects models will be used for analyses with the use of the statistical software SPSS V.20.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD.
The findings from this trial will help further explore the efficacy and safety of EA on losing weight for patients with obesity and prediabetes, as well as determine the differences between the EA and SA treatment.
- Conditions
- Obesity
- Being tested
- Electroacupuncture, Sham acupuncture, Health education
- Keywords
- Electroacupuncture, Obesity, Prediabetes, Sham acupuncture, Randomized Controlled Trial
- Medical subject headings
- Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
Regular acupuncture will be applied at the main and the additional acupoints with 0.25mm*40mm or 0.30mm*75mm needles. The main acupoints include Shangwan (CV13), Zhongwan (CV12), Jianli (CV11), Xiawan (CV10), bilateral Quchi (LI11), Hegu (LI4), Liangmen (ST21), Tianshu (ST25), Daheng (SP15), Fujie (SP14), Shuidao (ST28), Zusanli (ST36), Fenglong (ST40), Wailing (ST26), Guilai (ST29). Additional acupoints include bilateral Shangjuxu (ST37) and Neiting (ST44), bilateral Yinlingquan (SP9) and Shuifen (CV9), Qihai (CV6) and Guanyuan (CV4). Acupuncturists will use all main acupoints and choose the combined acupoints based on the patients' patterns during each treatment session. The EA apparatus will be connected to the needles at the bilateral ST21, ST25, SP15, using continuous wave type, frequency at 3 Hz, and intensity of 4-5 mA based on the endurance of each patient. Needles will be retained for 30 minutes before removal.
Sham acupunctureOther
Patients will receive superficial acupuncture treatment at the same main acupoints as EA group with 0.22*0.25mm needles. The electroacupuncture apparatus will connected to the needles at the bilateral Liangmen (ST21), Tianshu (ST25), Daheng (SP15) without current output. Needles will be retained for 30 minutes before removal. The treatment will be given 3 times a week in week 1-12, 2 times a week in week 13-20, and once a week in week 21-24, totaling 56 sessions of real or sham acupuncture.
Health educationOther
The health management brochure will be distributed to all patients in the trial after enrollment, and health education will be arranged online or offline at week 4, 8, 12, 16, 20 and 24 for about 60 minutes, including lifestyle, diet and physical activity. According to the specific situation of each patient, healthier individual lifestyle and behavior will be recommended to all patients, but there will be no strict restrictions on the diet or physical activity.
| Study group | Role | What they receive |
|---|---|---|
| EA group：Electroacupuncture+health education | Active comparator | Acupuncture is the most popular adjuvant and alternative therapy in China, and it has been used to treat various diseases for thousands of years. Electroacupuncture is an innovation of traditional Chinese acupuncture, which improves the clinical effect by transmitting electrical pulses to the needles and then enhances the stimulation at the acupoints to receive better effects. Studies show that EA has been used as an alternative therapy for obesity in clinical practice. Receives: Other: Electroacupuncture; Other: Health education |
| Sham acupuncture group：shallow acupuncture+health education | Sham comparator | Sham acupuncture method in this study is set as the superficial acupuncture manipulated at the same main acupoints with the thinner and shorter needles. The aim of the sham acupuncture is to eliminate the possible placebo effect of EA treatment. Receives: Other: Sham acupuncture; Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of patients who lost 10% of their body weight
We will calculate the proportion of people in each group who lost 10% or more of their baseline body weight at the end of the intervention period.
Measured: week 24
Secondary outcomes (13)
Changes of body weight from baseline to week 48
The change of body weight is an important factor of the development of diabetes. We will calculate the mean weight change in each group of patients during the intervention and follow-up period, compared with baseline data.
Measured: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Changes of BMI from baseline to week 48
BMI is a statistical index using a person's weight and height to provide an estimate of body fat in males and females of any age. It is calculated by taking a person's weight, in kilograms, divided by their height, in meters squared, or BMI = weight (kg)/ height2 (m2). BMI is used to define a person as underweight, normal weight, overweight, or obese by the National Institute of Health (NIH).
Measured: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Change of blood glucose from baseline to week 24
It is the concentration of glucose in the blood, including fasting plasma glucose (FBG) which reflects function of islet β cell and 2 hour postprandial blood glucose (2hPG) which reflects the reserve function of islet β cell.
Measured: baseline, week 24
Change of HbA1c from baseline to week 24
HbA1c reflects the average blood glucose level of diabetic patients in the past 8-12 weeks. HbA1c≥5.5% indicates the presence of insulin resistance, and ≥6.5% indicates the occurrence of diabetes.
Measured: baseline, week 24
Change of insulin resistance index (HOMA-IR) from baseline to week 24
HOMA-IR is one of the most common formulas to reflect the intensity of insulin resistance. The higher index indicates the more serious insulin resistance. Insulin resistance index (HOMA-IR) = fasting insulin (FINS)*fasting plasma glucose (FPG)/22.5, HOMA-IR > 1 indicates the presence of insulin resistance.
Measured: baseline, week 24
Change of blood lipid from baseline to week 24
Blood lipid includes low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and total cholesterol (TC), which reflects the internal lipid metabolism of whole body.
Measured: baseline, week 24
Change of fat and muscle mass from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including body fat mass and skeletal muscle mass. The body fat mass reveals how much body fat makes up the weight, both surface level (subcutaneous) and internal (visceral). skeletal muscle mass is the muscle that can be grown and developed through exercise. And the muscle-fat analysis tells you whether you have a healthy balance of SMM and Body Fat Mass in respect to your weight.
Measured: baseline, week 24
Change of percentage body fat from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including percent body fat. Body fat percentage is a division of the participant's body fat mass by his/her total weight and a much better indicator of the risk of obesity than BMI.
Measured: baseline, week 24
Change of basal metabolic rate from baseline to week 24
The non-invasive body composition analyzer (Inbody 770) of the Inbody company can be used to measure high density body composition through bioelectrical impedance analysis, including the basal metabolic rate. BMR is the calories that one person needs for the basic essential functions. It allows the individual to work with the dietician to create a nutritional plan, which is key to reaching the body composition goals.
Measured: baseline, week 24
Change of fat tissue size from baseline to week 24
Abdominal magnetic resonance imaging (MRI) scan will be used to scan the upper abdomen and flat umbilical layer to quantitatively calculate abdominal fat size and the ratio of intra-abdominal and subcutaneous fat size.
Measured: baseline, week 24
Impact of weight on quality of life (IWQOL-Lite)
It is a 31-item self-report questionnaire measuring the quality of life of obese patients (or those with type 2 diabetes). it consists of the following 5 dimensions: physical functioning, self-esteem, sexual life, public stress, and work included.
Measured: baseline, week 8,16, 24, 32, 40 and week 48
Three Factor Eating Questionnaire-R21(TFEQ-R21)
TFEQ is one of the most widely used instruments to study different eating behaviors. It assesses three cognitive and behavioral domains of eating: cognitive restraint (6 items), uncontrolled eating (9 items) and emotional eating (6 items). It comprises 21 items in a four-point Likert scale for items 1-20 and on an eight-point numerical rating scale for item 21. Responses to each of the items are given a score between 1 and 4. Before calculating domain scores, items 1-16 were reverse coded and item 21 was recoded as follows: 1-2 scores as 1; 3-4 as 2; 5-6 as 3; 7-8 as 4.
Measured: baseline, week 8,16, 24, 32, 40 and week 48
Food Cravings Questionnaire-Trait (FCQ-T)
It measures the frequency and intensity of food craving experiences in patients. The questionnaire has 39 items and response categories range from 1 = never to 6 = always. There are no inverted items. Responses to all items are summed up for a total score. Higher scores represent more frequent and intense food cravings.
Measured: baseline, week 8,16, 24, 32, 40 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Electroacupuncture group and the Sham acupuncture group (the control group).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shifen Xu, PhD, Study director, Shanghai Municipal Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237089
- Sponsor's protocol ID
- XSF20211230
- Status last verified
- Nov 2022
- First submitted
- 28 Dec 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
Publications
Li X, Lin J, Hu C, Liu B, Li F, Li J, Zeng X, Li S, Mi Y, Yin X, Xu S. Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial. BMJ Open. 2024 Mar 8;14(3):e075873. doi: 10.1136/bmjopen-2023-075873.
PubMed 38458786
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture on Weight Loss in Obese Patients With Prediabetes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05237089
- Acronym / sponsor ID
- XSF20211230
- Conditions
- Obesity
- Keywords
- Electroacupuncture, Obesity, Prediabetes, Sham acupuncture, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of electroacupuncture on losing weight in obese patients with prediabetes.
Detailed description
Obesity has emerged as a contributing factor in diabetes mellitus. In 2015, about 4 million deaths worldwide were directly related to high BMI, accounting for 7.1% of all deaths; among them, 41% died due to cardiovascular disease, followed by diabetes mellitus. China has become the country with the largest number of obese people and diabetic patients in the world. According to the clinical practice guidelines for medical care of obese patients announced by AACE and ACE, obese patients with prediabetes can effectively prevent the development of diabetes by lose 10% or more than of their body weight. Acupuncture is a widely recognized therapy to lose weight in clinical practice. But there are some doubts about the effectiveness of acupuncture versus sham acupuncture in treating obesity due to its lack of medical evidence.
This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of Electroacupuncture (EA) in obese patients with prediabetes. The investigators designed a protocol for a randomized controlled trial, in which 256 eligible patients will be randomly assigned to one of the two groups in a ratio of 1:1, the EA group (receiving EA treatment with health education) and the sham electroacupuncture (SA) group (receiving superficial acupuncture treatment with health education). A total of 56 sessions of interventions will be given for consecutive 24 weeks, followed by a 24-week follow-up period. Each session of EA or SA treatment will last for about 30 minutes. The primary outcome is the proportion of patients who lost 10% or more than of their body weight at week 24. The secondary outcomes include the change of patient's body weight and body mass index (BMI), results from the blood tests (FBG, 2hPG, HbA1c, HOMA-IR, LDL-C, HDL-C, TG and TC, ect.), the fat tissue size scanned by abdominal magnetic resonance imaging (MRI), data collected from the body composition analyzer, the and scores of the impact of weight on quality of life (IWQOL-Lite), Three Factor Eating Questionnaire - R21 (TFEQ-R21) and Food Cravings Questionnaire-Trait (FCQ-T). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS) from baseline to the follow-up period. The body weight and BMI will be calculated at baseline, week 8, week 16, week 24, week 32, week 40 and week 48, as well as the IWQOL-Lite, the TFEQ-R21 and the FCQ-T. Blood tests will be analyzed at baseline and week 24, as well as the body composition analyzer and the MRI scan. All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 24-week intervention period.
All analyses will be performed on the intention-to-treat (ITT) population of participants who have at least one treatment. Missing data will be handled using the multiple imputation method, on the assumption that values at each time point follow a specific distribution calculated by the computer software R V.3.5. The primary analysis will be a comparison of the proportion of patients who losing 10% or more than of their body weight between the two groups at 24 weeks after inclusion (comparison of the primary endpoint). Linear mixed-effects models will be used for analyses with the use of the statistical software SPSS V.20.0. The t-test will be used to compare the measurement data between either two groups from the baseline to follow-up; the rank sum test will be used for ranked data while the Chi-squared test will be used to analyze categorical data. The significance level that will be used for statistical analysis with 2-tailed testing will be 2.5%. Data values will mainly be presented as Mean±SD.
The findings from this trial will help further explore the efficacy and safety of EA on losing weight for patients with obesity and prediabetes, as well as determine the differences between the EA and SA treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Electroacupuncture group and the Sham acupuncture group (the control group).
| Arm | Type | Receives |
|---|---|---|
| EA group：Electroacupuncture+health education | Active comparator | Other: Electroacupuncture, Other: Health educationAcupuncture is the most popular adjuvant and alternative therapy in China, and it has been used to treat various diseases for thousands of years. Electroacupuncture is an innovation of traditional Chinese acupuncture, which improves the clinical effect by transmitting electrical pulses to the needles and then enhances the stimulation at the acupoints to receive better effects. Studies show that EA has been used as an alternative therapy for obesity in clinical practice. |
| Sham acupuncture group：shallow acupuncture+health education | Sham comparator | Other: Sham acupuncture, Other: Health educationSham acupuncture method in this study is set as the superficial acupuncture manipulated at the same main acupoints with the thinner and shorter needles. The aim of the sham acupuncture is to eliminate the possible placebo effect of EA treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 18-65;
- Participant whose BMI is ≥24.0 kg/m2;
- Participants whose HbA1c measurement of 5.7-6.4% both inclusive, or fasting plasma glucose measurement ≥ 6.1 mmol/liter and <7.0 mmol/liter, or 2-hour plasma glucose measurement post-challenge (oral glucose tolerance test) ≥7.8 mmol/liter and <11.1 mmol/liter;
- Participants with stable weight within 3 months before the start of the trial, fluctuated within 4 kg;
- Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.
Key exclusion criteria (8 listed)
- Patients with secondary obesity caused by drugs or neuro-endocrine-metabolic disorders (such as hypothalamic disease and hypopituitarism);
- Patients who have been diagnosed with type I or type II diabetes;
- Patients who are taking medication which cause clinically significant weight gain or loss;
- Patients whose Hamilton 17-item Depression Scale (HAMD-17) score >18 or have a history of other severe psychiatric disorders;
- Patients with severe ulcer, abscess and skin infection at the local acupuncture area;
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 |
|---|---|---|
| ElectroacupunctureRegular acupuncture will be applied at the main and the additional acupoints with 0.25mm*40mm or 0.30mm*75mm needles. The main acupoints include Shangwan (CV13), Zhongwan (CV12), Jianli (CV11), Xiawan (CV10), bilateral Quchi (LI11), Hegu (LI4), Liangmen (ST21), Tianshu (ST25), Daheng (SP15), Fujie (SP14), Shuidao (ST28), Zusanli (ST36), Fenglong (ST40), Wailing (ST26), Guilai (ST29). Additional acupoints include bilateral Shangjuxu (ST37) and Neiting (ST44), bilateral Yinlingquan (SP9) and Shuifen (CV9), Qihai (CV6) and Guanyuan (CV4). Acupuncturists will use all main acupoints and choose the combined acupoints based on the patients' patterns during each treatment session. The EA apparatus will be connected to the needles at the bilateral ST21, ST25, SP15, using continuous wave type, frequency at 3 Hz, and intensity of 4-5 mA based on the endurance of each patient. Needles will be retained for 30 minutes before removal. | Other | EA group：Electroacupuncture+health education |
| Sham acupuncturePatients will receive superficial acupuncture treatment at the same main acupoints as EA group with 0.22*0.25mm needles. The electroacupuncture apparatus will connected to the needles at the bilateral Liangmen (ST21), Tianshu (ST25), Daheng (SP15) without current output. Needles will be retained for 30 minutes before removal. The treatment will be given 3 times a week in week 1-12, 2 times a week in week 13-20, and once a week in week 21-24, totaling 56 sessions of real or sham acupuncture. | Other | Sham acupuncture group：shallow acupuncture+health education |
| Health educationThe health management brochure will be distributed to all patients in the trial after enrollment, and health education will be arranged online or offline at week 4, 8, 12, 16, 20 and 24 for about 60 minutes, including lifestyle, diet and physical activity. According to the specific situation of each patient, healthier individual lifestyle and behavior will be recommended to all patients, but there will be no strict restrictions on the diet or physical activity. | Other | EA group：Electroacupuncture+health education, Sham acupuncture group：shallow acupuncture+health education |
Primary outcome
The Percentage of patients who lost 10% of their body weight
Time frame: week 24
We will calculate the proportion of people in each group who lost 10% or more of their baseline body weight at the end of the intervention period.
13 secondary outcomes
Changes of body weight from baseline to week 48
Time frame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Changes of BMI from baseline to week 48
Time frame: baseline, week 8, week 16, week 24, week 32, week 40 and week 48
Change of blood glucose from baseline to week 24
Time frame: baseline, week 24
Change of HbA1c from baseline to week 24
Time frame: baseline, week 24
Change of insulin resistance index (HOMA-IR) from baseline to week 24
Time frame: baseline, week 24
Change of blood lipid from baseline to week 24
Time frame: baseline, week 24
Change of fat and muscle mass from baseline to week 24
Time frame: baseline, week 24
Change of percentage body fat from baseline to week 24
Time frame: baseline, week 24
Change of basal metabolic rate from baseline to week 24
Time frame: baseline, week 24
Change of fat tissue size from baseline to week 24
Time frame: baseline, week 24
Impact of weight on quality of life (IWQOL-Lite)
Time frame: baseline, week 8,16, 24, 32, 40 and week 48
Three Factor Eating Questionnaire-R21(TFEQ-R21)
Time frame: baseline, week 8,16, 24, 32, 40 and week 48
Food Cravings Questionnaire-Trait (FCQ-T)
Time frame: baseline, week 8,16, 24, 32, 40 and week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 38458786Li X, Lin J, Hu C, Liu B, Li F, Li J, Zeng X, Li S, Mi Y, Yin X, Xu S. Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial. BMJ Open. 2024 Mar 8;14(3):e075873. doi: 10.1136/bmjopen-2023-075873.
- Individual participant dataSharing planned: Yes. The data in this trial will be publicly available from the corresponding author upon reasonable request. All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
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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.
Shifen Xu, PhD study director
Shanghai Municipal Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Health education in people with Obesity, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 10 Nov 2022. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shifen Xu, PhD (+8613761931393, xu_teacher2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of patients who lost 10% of their body weight (time frame: week 24). 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 NCT05237089, 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 10 Nov 2022.