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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847478
• Other study ID #: AP_IDR_2.0
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: Weili Yan
• Phone: +86 02164931215
• Email: yanwl[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight	The body weight will be measured by fixed research staff at baseline and one month after intervention.	From baseline to one month after intervention
Secondary	changes in the cumulative score of traditional Chinese medicine syndromes	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	From baseline to three month after intervention
Secondary	Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc	Serum from fasting blood sample is used for measurement of glucose metabolism at baseline, one month and three month after intervention.	From baseline to three month after intervention
Secondary	Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure	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.	From baseline to three month after intervention
Secondary	Changes in body fat content	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.	From baseline to three month after intervention
Secondary	Changes in blood lipid ,liver and kidney function level	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.	From baseline to three month after intervention
Secondary	Changes in Gut microbiota	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.	From baseline to one month after intervention
Secondary	Changes in dietary and exercise data	Diet and exercise data are recorded by the children and their families, but they will be educated by qualified clinicians before recording.	From baseline to three month after intervention