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

Fudan University

Status: Enrolling

Conditions: Obesity, Childhood

Treatments: Behavioral: Intermittent low carbohydrate diet; Behavioral: Health education; Other: Auricular acupressure of traditional Chinese Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05847478

AP_IDR_2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Auricular acupressure therapy group (AAT)

Experimental group

Description:

The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.

Treatment:

Other: Auricular acupressure of traditional Chinese Medicine

Behavioral: Health education

Intermittent low carbohydrate diet group (ILCD)

Experimental group

Description:

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.

Treatment:

Behavioral: Health education

Behavioral: Intermittent low carbohydrate diet