Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Childhood
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Changes in body weight
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes in body weight
Time Frame: 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 Outcomes
- Changes in blood lipid ,liver and kidney function level(From baseline to three month after intervention)
- changes in the cumulative score of traditional Chinese medicine syndromes(From baseline to three month after intervention)
- Changes in body fat content(From baseline to three month after intervention)
- Changes in dietary and exercise data(From baseline to 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)
- Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc(From baseline to three month after intervention)
- Changes in Gut microbiota(From baseline to one month after intervention)