Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05847478

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular acupressure of traditional Chinese Medicine

Other

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.

Intermittent low carbohydrate diet

Behavioral

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.

Health Education

Behavioral

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.

Primary outcomes

  1. 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

  1. changes in the cumulative score of traditional Chinese medicine syndromes

    Time frame: 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

  2. Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc

    Time frame: 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.

  3. Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure

    Time frame: 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.

  4. Changes in body fat content

    Time frame: 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.

  5. Changes in blood lipid ,liver and kidney function level

    Time frame: 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.

  6. Changes in Gut microbiota

    Time frame: 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.

  7. Changes in dietary and exercise data

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weili Yan

CONTACT

[email protected]

+86 02164931215

Wen Sun

CONTACT

[email protected]

+86 13818844692

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 6, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.