Clinical trial NCT05847478: Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
Official title: Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Keywords: Auricular acupressure
Intermittent dietary restriction
Gastric Heat and Dampness Obstruction
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes in body weight
timeFrame: From baseline to one month after intervention
Secondary outcomes:
measure: changes in the cumulative score of traditional Chinese medicine syndromes
timeFrame: From baseline to three month after intervention
measure: Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc
timeFrame: From baseline to three month after intervention
measure: Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure
timeFrame: From baseline to three month after intervention
measure: Changes in body fat content
timeFrame: From baseline to three month after intervention
measure: Changes in blood lipid ,liver and kidney function level
timeFrame: From baseline to three month after intervention
measure: Changes in Gut microbiota
timeFrame: From baseline to one month after intervention
measure: Changes in dietary and exercise data
timeFrame: From baseline to three month after intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References: