This is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus Intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.
Have at least one of the following cardiometabolic risk factors: overweight or obesity, prediabetes, dyslipidemia or elevated blood pressure.
Traditional Chinese medical syndrome type is gastric heat and dampness obstruction syndrome.
Diagnosis of obesity associated with genetic or endocrine diseases, including hypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamic obesity.
Participating in other clinical trials or have participated in other clinical trials in recent 3 months.
Diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.
Parallel
Auricular acupressure of traditional Chinese Medicine
Other interventionThe participants will be randomly assigned to receive the auricular point patch therapy. The selected acupoints include Shenmen, hungry point, endocrine, stomach, mouth and subcortical. The opaque patch with vaccaria seed is used for acupoint pressing. Pressing the acupoints once a day before and after eating, each time for 1 minute, lasting for 2-3 days, follow up visit once a week. The intervention period is 3 months.
Intermittent low carbohydrate diet
BehavioralThe participants will be randomly assigned to the intermittent low carbohydrate diet group. The intermittent carbohydrate diet includes 7 days of low carbohydrate diet within 2 weeks (consecutive or nonconsecutive, carbohydrate intake be controlled as ≤ 50g per day). The study duration is 3 months, including 1-month intervention period and 2-month self-maintenance period.
Health education
BehavioralHealth education is conducted once a week during 3-month intervention for all participants. Health education including the understanding of childhood obesity and cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
Changes in body weight
The body weight will be measured by fixed research staff at baseline and one month after intervention.
changes in the cumulative score of traditional Chinese medicine syndromes
The investigators will measure the change in scores of chinese medicine symptoms according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe
Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc
Serum from fasting blood sample is used for measurement of glucose metabolism at baseline, one month and three month after intervention.
Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure
The weight、height、waist circumference and blood pressure will be measured by fixed research staff at baseline , one month and three month after intervention. BMI and WtHR are calculated using the corresponding equation.
Changes in body fat content
Body composition involves measuring the body fat percentage by using the LUNAR DPX Dual Energy X-ray Absorptiometry (DXA) equipment (General Electric Company, USA)) at baseline , one month and three month after intervention.
Click on the lead sponsor to view all of their trials.
