Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 19, 2026
March 1, 2026
3.5 years
April 27, 2023
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
changes in the cumulative score of traditional Chinese medicine syndromes
From baseline to three month after intervention
Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc
From baseline to three month after intervention
Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure
From baseline to three month after intervention
Changes in body fat content
From baseline to three month after intervention
Changes in blood lipid ,liver and kidney function level
From baseline to three month after intervention
- +2 more secondary outcomes
Study Arms (2)
Auricular acupressure therapy group (AAT)
EXPERIMENTALThe participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.
Intermittent low carbohydrate diet group (ILCD)
EXPERIMENTALThe participants will be randomly assigned to receive the intermittent low carbohydrate diet. The duration of the study is 3 months, including 1-month intervention period and 2-month self maintenance period.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, 201102, China
Related Publications (1)
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: 40053799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 6, 2023
Study Start
June 7, 2023
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03