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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Changes in body weight [Срок оценки: From baseline to one month after intervention]

Вторичные конечные точки (7)

• changes in the cumulative score of traditional Chinese medicine syndromes [Срок оценки: From baseline to three month after intervention]
• Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc [Срок оценки: From baseline to three month after intervention]
• Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure [Срок оценки: From baseline to three month after intervention]
• Changes in body fat content [Срок оценки: From baseline to three month after intervention]
• Changes in blood lipid ,liver and kidney function level [Срок оценки: From baseline to three month after intervention]
• Changes in Gut microbiota [Срок оценки: From baseline to one month after intervention]
• Changes in dietary and exercise data [Срок оценки: From baseline to three month after intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Публикации

• 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

Идентификаторы

NCT: NCT05847478 · AP_IDR_2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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