RecruitingNot ApplicableNCT05847478

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

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


Sponsor

Children's Hospital of Fudan University

Enrollment

240 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria2

  • 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 Criteria3

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAuricular 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.

BEHAVIORALIntermittent 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.

BEHAVIORALHealth 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.


Locations(1)

Children's Hospital of Fudan University

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05847478


Related Trials