Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316310
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-03-12
Brief Title:
Effect of Acupoint Thread Embedding on Obesity
Sponsor:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Organization:
Shanghai Municipal Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
The Effect and Safety of Acupoint Thread Embedding on Over-weight and Obesity Treatment A Randomized Single-Blind Sham- Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients
Detailed Description:
Obesity refers to a complex chronic disease in which there is excessive accumulation of body fat As of 2016 there were more than 650 million obese people worldwide and it is expected to reach 112 billion by 2030 with at least 28 million deaths due to obesity each year according to surveys In Europe 60 percent of the population is already overweight or obese The incidence of obesity is also increasing rapidly in China with a recent report by The Lancet showing that the number of obese people in China has reached 85 million making it the country with the highest number of obese people in the world In 2002 the China Obesity Task Force recommended threshold value to define overweight as Body Mass Index BMI of 24 kgm2 a waist circumference WC of 85 cm for men and a WC 80 cm for women or a Waist-to-Hip Ratio WHR of 09 for men and a WHR 08 for women and to define obesity as a BMI 28 kgm2 Studies have shown that Asian populations have higher health risks at the same BMI and WC levels due to the distribution of adipose tissue Acupoint thread embedding is a widely recognized therapy to lose weight in clinical practiceBut there are some doubts about the effectiveness of acupoint thread embedding versus sham acupoint thread embedding 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 acupoint thread embedding ATE in obese patients The investigators designed a protocol for a randomized controlled trial in which 132 eligible patients will be randomly assigned to one of the two groups the ATE group receiving ATE treatment with health education and the sham acupoint thread embedding SATE group receiving SATE treatment with health education A total of 6 sessions of interventions will be given for consecutive 12 weeks followed by 12 weeks follow-up period Each session of ATE or SATE treatment will last for about 30 minutes The primary outcome is the change of the body mass index BMI at week 12 The secondary outcomes include the change of patients body weight and body circumference results from the blood tests FBG LDL-C HDL-C TG and TC the abdominal visceral fat tissue thickness scanned by abdominal B-ultrasound data collected from the body composition analyzer the and scores of the impact of weight on quality of life IWQOL-Lite the well-being index WHO-5 visual analog scale VAS of appetite and hamilton anxiety scaleHAMA All adverse effects will be accessed by the treatment emergent symptom scale TESS from baseline to the follow-up period The body weight and circumferences and BMI will be calculated at baseline week 6 week 12 and week 24 The IWQOL-Lite WHO-5 VAS the HAMA blood tests and abdominal B-ultrasound will be calculated at baseline and week 12 All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-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 V35 The primary outcome is the change of the body mass index BMI at week 12 Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V200 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 25 Data values will mainly be presented as MeanSD The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity as well as determine the differences between the ATE and SATE treatment
This randomized placebo-controlled clinical trial is aimed to investigate the effect and safety of acupoint thread embedding ATE in obese patients The investigators designed a protocol for a randomized controlled trial in which 132 eligible patients will be randomly assigned to one of the two groups the ATE group receiving ATE treatment with health education and the sham acupoint thread embedding SATE group receiving SATE treatment with health education A total of 6 sessions of interventions will be given for consecutive 12 weeks followed by 12 weeks follow-up period Each session of ATE or SATE treatment will last for about 30 minutes The primary outcome is the change of the body mass index BMI at week 12 The secondary outcomes include the change of patients body weight and body circumference results from the blood tests FBG LDL-C HDL-C TG and TC the abdominal visceral fat tissue thickness scanned by abdominal B-ultrasound data collected from the body composition analyzer the and scores of the impact of weight on quality of life IWQOL-Lite the well-being index WHO-5 visual analog scale VAS of appetite and hamilton anxiety scaleHAMA All adverse effects will be accessed by the treatment emergent symptom scale TESS from baseline to the follow-up period The body weight and circumferences and BMI will be calculated at baseline week 6 week 12 and week 24 The IWQOL-Lite WHO-5 VAS the HAMA blood tests and abdominal B-ultrasound will be calculated at baseline and week 12 All patients will be provided with the same health education brochure to choose more beneficial personalized lifestyle during the 12-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 V35 The primary outcome is the change of the body mass index BMI at week 12 Linear mixed effects models will be used for analyses with the use of the statistical software SPSS V200 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 25 Data values will mainly be presented as MeanSD The findings from this trial will help further explore the efficacy and safety of ATE on losing weight for patients with obesity as well as determine the differences between the ATE and SATE treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None