Obesity, Childhood
Conditions
Keywords
Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction
Brief summary
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
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.
Interventions
OTHERAuricular acupressure of traditional Chinese Medicine
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.
BEHAVIORALIntermittent low carbohydrate diet
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.
BEHAVIORALHealth education
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.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | From baseline to one month after intervention | The body weight will be measured by fixed research staff at baseline and one month after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the cumulative score of traditional Chinese medicine syndromes | From baseline to three month after intervention | 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 | From baseline to three month after intervention | 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 | From baseline to three month after intervention | 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 | From baseline to three month after intervention | 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. |
| Changes in blood lipid ,liver and kidney function level | From baseline to three month after intervention | 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. |
| Changes in Gut microbiota | From baseline to one month after intervention | 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. |
| Changes in dietary and exercise data | From baseline to three month after intervention | Diet and exercise data are recorded by the children and their families, but they will be educated by qualified clinicians before recording. |
Countries
China
Contacts
CONTACTWeili Yan
CONTACTWen Sun
Outcome results
None listed