Catgut Implantation at Acupoints for the Treatment of Simple Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The primary objective of this multicenter randomized controlled trial is to evaluate
      treatment effectiveness of intervening simple obesity people with catgut implantation at
      preferred acupoints, which excludes placebo effect; the secondary objective is to evaluate
      safety and superiority of treating simple obesity with catgut implantation at acupoints to
      provide high-level evidence for it clinically.
    

Detailed description: 
      This randomized, double-blind sham-controlled clinical trial will be conducted at Hubei
      Provincial Hospital of TCM, Dongzhimen Hospital Beijing University of Chinese Medicine and
      the First Hospital of Hunan University of Chinese Medicine. This study includes the following
      time points: a treatment period of 16 weeks after screening and a follow-up period of 24
      weeks. The total study period will be 40 weeks. All patients will be randomized into the real
      catgut implantation at acupoints group or the sham catgut implantation at acupoints group.The
      primary outcome measurement of this study is the rate of waistline reduction compared with
      baseline. The secondary outcome measurements are the rate of reduction of weight, BMI,
      hipline, WHR and PBF, and changes in the IWQOL-Lite compared with baseline. These parameters
      will be evaluated at week 0, week 4, week 8, week 12, week 16, week 28 and week 40. Changes
      in SF-36, HAD and SES compared with baseline will be evaluated at week 0, week 16 and week
      40. SF-36 and IWQOL-Lite will be used to evaluate obese patient quality of life. HAD and SES
      will be used to evaluate psychological status. In addition, hepatorenal function, blood fat,
      liver bladder spleen colour ultrasound, FBG and insulin concentration will be used to
      evaluate whether catgut implantation at acupoints can improve the physiological function of
      obese patients.
    

Intervention name(s): Real catgut implantation at acupoints; sham catgut implantation at acupoints
Intervention type(s): Device; Device
Intervention description(s): Absorbable surgical suture will be embedded in acupoints as below. Group A ：Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks.
lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .; Empty needles without catgut will be pushed into the chosen position as below :Group A ：1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks.
lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: simple obesity; catgut implantation