Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular acupressure of traditional Chinese Medicine, Intermittent low carbohydrate diet, Health education.
- Who it may be relevant to
- Registry conditions: Obesity, Childhood. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
Overview
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
- Other Auricular 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. - Behavioral Intermittent 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. - Behavioral Health 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.
Primary outcome measures
- Changes in body weight [Time frame: From baseline to one month after intervention]
Secondary outcome measures (7)
- changes in the cumulative score of traditional Chinese medicine syndromes [Time frame: From baseline to three month after intervention]
- Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc [Time frame: From baseline to three month after intervention]
- Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure [Time frame: From baseline to three month after intervention]
- Changes in body fat content [Time frame: From baseline to three month after intervention]
- Changes in blood lipid ,liver and kidney function level [Time frame: From baseline to three month after intervention]
- Changes in Gut microbiota [Time frame: From baseline to one month after intervention]
- Changes in dietary and exercise data [Time frame: From baseline to three month after intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Publications
- Sun W, He J, Wang W, Lu C, Lin Y, Dou Y, Yan W, Yu J. Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 3;14:e59856. doi: 10.2196/59856. PMID 40053799
Identifiers
NCT: NCT05847478 · AP_IDR_2.0