Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Other: Auricular acupressure of traditional Chinese Medicine
* Behavioral: Intermittent low carbohydrate diet
* Behavioral: Health education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular acupressure therapy group (AAT)<br>The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months. | Other: Auricular acupressure of traditional Chinese Medicine<br>* 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.<br>Behavioral: Health education<br>* 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.<br>|
| Experimental: Intermittent low carbohydrate diet group (ILCD)<br>The participants will be randomly assigned to receive the intermittent low carbohydrate diet. The duration of the study is 3 months, including 1-month intervention period and 2-month self maintenance period. | Behavioral: Intermittent low carbohydrate diet<br>* 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.<br>Behavioral: Health education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight | The body weight will be measured by fixed research staff at baseline and one month after intervention. | From baseline to one month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | From baseline to three month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction