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

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Auricular acupressure of traditional Chinese Medicine
Intermittent low carbohydrate diet
Health education
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Childhood focused on measuring Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Auricular acupressure therapy group (AAT)

Intermittent low carbohydrate diet group (ILCD)

Arm Description

The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change 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
Changes in insulin level
Serum from fasting blood sample is used for measurement of insulin at baseline and one month after intervention.

Full Information

First Posted
April 27, 2023
Last Updated
June 7, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05847478
Brief Title
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
Official Title
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
Keywords
Auricular acupressure, Intermittent dietary restriction, Gastric Heat and Dampness Obstruction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupressure therapy group (AAT)
Arm Type
Experimental
Arm Description
The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.
Arm Title
Intermittent low carbohydrate diet group (ILCD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Auricular acupressure of traditional Chinese Medicine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent low carbohydrate diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
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 Outcome Measure Information:
Title
Changes in body weight
Description
The body weight will be measured by fixed research staff at baseline and one month after intervention.
Time Frame
From baseline to one month after intervention
Secondary Outcome Measure Information:
Title
change in the cumulative score of traditional Chinese medicine syndromes
Description
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
Time Frame
From baseline to one month after intervention
Title
Changes in insulin level
Description
Serum from fasting blood sample is used for measurement of insulin at baseline and one month after intervention.
Time Frame
From baseline to one month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Yan
Phone
+86 02164931215
Email
yanwl@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Sun
Phone
+86 13818844692
Email
sunwenhere@163.com
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Sun
Phone
(86)13818844692
Email
sunwenhere@163.com

12. IPD Sharing Statement

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

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