Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05847478

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Childhood

Full registry 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.

Treatments and study arms

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

Changes in body weightFrom baseline to one month after intervention

The body weight will be measured by fixed research staff at baseline and one month after intervention.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Children's Hospital of Fudan University🇨🇳 Shanghai, China

Open map

Wen SunContact

Email · Call (86)13818844692