Obesity, ChildhoodNCT05847478
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
A study testing Auricular acupressure of traditional Chinese Medicine, Intermittent low carbohydrate diet and Health education in people with Obesity, Childhood, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Auricular acupressure of traditional Chinese Medicine, Intermittent low carbohydrate diet and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Wen Sun, (86)13818844692, sunwenhere@163.com
About this study
Official title: Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Obesity, Childhood
- Being tested
- Auricular acupressure of traditional Chinese Medicine, Intermittent low carbohydrate diet, Health education
- Keywords
- Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressure of traditional Chinese MedicineOther
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 dietBehavioural
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupressure therapy group (AAT) | Experimental | The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months. Receives: Other: Auricular acupressure of traditional Chinese Medicine; Behavioral: Health education |
| Intermittent low carbohydrate diet group (ILCD) | Experimental | The 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. Receives: Behavioral: Intermittent low carbohydrate diet; Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
The body weight will be measured by fixed research staff at baseline and one month after intervention.
Measured: From baseline to one month after intervention
Secondary outcomes (7)
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
Measured: From baseline to three month after intervention
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.
Measured: From baseline to three month after intervention
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.
Measured: From baseline to three month after intervention
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.
Measured: From baseline to three month after intervention
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.
Measured: From baseline to three month after intervention
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.
Measured: From baseline to one month after intervention
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.
Measured: From baseline to three month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Jun 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847478
- Sponsor's protocol ID
- AP_IDR_2.0
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40053799
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05847478
- Acronym / sponsor ID
- AP_IDR_2.0
- Conditions
- Obesity, Childhood
- Keywords
- Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupressure therapy group (AAT) | Experimental | Other: Auricular acupressure of traditional Chinese Medicine, Behavioral: Health educationThe participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months. |
| Intermittent low carbohydrate diet group (ILCD) | Experimental | Behavioral: Intermittent low carbohydrate diet, Behavioral: Health educationThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupressure of traditional Chinese MedicineThe 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. | Other | Auricular acupressure therapy group (AAT) |
| Intermittent low carbohydrate dietThe 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. | Behavioural | Intermittent low carbohydrate diet group (ILCD) |
| Health educationHealth 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. | Behavioural | Auricular acupressure therapy group (AAT), Intermittent low carbohydrate diet group (ILCD) |
Primary outcome
Changes in body weight
Time frame: From baseline to one month after intervention
The body weight will be measured by fixed research staff at baseline and one month after intervention.
7 secondary outcomes
changes in the cumulative score of traditional Chinese medicine syndromes
Time frame: From baseline to three month after intervention
Changes in glucose metabolism level, including fasting blood glucose, glycated hemoglobin, insulin level, etc
Time frame: From baseline to three month after intervention
Changes in waist-to-height ratio(WtHR), body mass index (BMI) and blood pressure
Time frame: From baseline to three month after intervention
Changes in body fat content
Time frame: From baseline to three month after intervention
Changes in blood lipid ,liver and kidney function level
Time frame: From baseline to three month after intervention
Changes in Gut microbiota
Time frame: From baseline to one month after intervention
Changes in dietary and exercise data
Time frame: From baseline to three month after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 40053799Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure of traditional Chinese Medicine, Intermittent low carbohydrate diet and Health education in people with Obesity, Childhood, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Yan (+86 02164931215, yanwl@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: From baseline to one month after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.