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.
Obesity in childhood is associated with multiple cardiometabolic risk factors including hyperglycemia, dyslipidemia and hypertension, which predicts increased risk for developing obesity-driven complications in adulthood. Auricular acupuncture therapy is an intervention with purported success for the treatment of obesity. However, traditional intervention rarely has long-term success in children and adolescents. Low-carbohydrate diets have also been shown to reduce body weight and improve insulin sensitivity in children. This is a three-month randomized controlled trial in children with gastric damp-heat obstruction, in order to explore the effects of traditional Chinese medicine auricular acupressure and intermittent carbohydrate restriction on cardiovascular metabolic health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
The 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.
The 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.
Children's Hospital of Fudan University
Shanghai, China
RECRUITINGChanges in body weight
The body weight will be measured by fixed research staff at baseline and one month after intervention.
Time frame: From baseline to 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
Time frame: From baseline to three month after intervention
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.
Time frame: From baseline to 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.
Time frame: From baseline to three month after intervention
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.
Time frame: From baseline to three month after intervention
Changes in blood lipid ,liver and kidney function level
Serum from fasting blood sample is used for measurement of blood lipid ,liver and kidney function at baseline, one month and three month after intervention.
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Health 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.
Time frame: From baseline to three month after intervention
Changes in Gut microbiota
Stool samples are collected with Boyou®- nucleic acid storage tube and stored in the laboratory -80℃ refrigerator at the baseline and one month after intervention. For the study of intestinal flora diversity, the 16SrDNA target region is amplified, and the information of intestinal microbial diversity and community composition is obtained by detecting the sequence variation and abundance of the target region.
Time frame: From baseline to one month after intervention
Changes in dietary and exercise data
Diet and exercise data are recorded by the children and their families, but they will be educated by qualified clinicians before recording.
Time frame: From baseline to three month after intervention