ChiCTR2600121881 版本V1.0 版本创建时间2026/04/07 08:57:14 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600121881 

最近更新日期：

Date of Last Refreshed on：

 2026-04-07 08:57:08 

注册时间：

Date of Registration：

 2026-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

“家校医社联动”模式下6-12岁儿童肥胖运动-营养综合干预效果评估

Public title：

Evaluation of the effect of a comprehensive exercise-nutrition intervention for childhood obesity aged 6-12 years under the "family-school-medical-community linkage" model

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“家校医社联动” 模式下 6-12 岁儿童肥胖运动 - 营养综合干预效果评估

Scientific title：

Evaluation of the effect of a comprehensive exercise-nutrition intervention for childhood obesity aged 6-12 years under the "family-school-medical-community linkage" model

研究课题代号(代码)：

Study subject ID：

 CQMCHA-NH2025-03

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

车平 

研究负责人：

车平 

Applicant：

Che Ping 

Study leader：

Che Ping 

申请注册联系人电话：

Applicant telephone：

 +86 189 9600 7513

研究负责人电话：

Study leader's
telephone：

+86 189 9600 7513

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 147919921@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 147919921@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国重庆市沙坪坝区井口街道嘉朗路2号

研究负责人通讯地址：

中国重庆市沙坪坝区井口街道嘉朗路2号

Applicant address：

No. 2, Jialang Road, Jingkou Subdistrict, Shapingba District, Chongqing, China

Study leader's address：

No. 2, Jialang Road, Jingkou Subdistrict, Shapingba District, Chongqing, China

申请注册联系人邮政编码：

Applicant postcode：

 401147

研究负责人邮政编码：

Study leader's postcode：

 401147

申请人所在单位：

重庆大学附属沙坪坝医院(重庆市沙坪坝区人民医院)

Applicant's institution：

Shapingba Hospital affiliated to Chongqing University(Shapingba District People's Hospital of Chongqing)

研究负责人所在单位：

重庆大学附属沙坪坝医院(重庆市沙坪坝区人民医院)

Affiliation of the Leader：

Shapingba Hospital affiliated to Chongqing University(Shapingba District People's Hospital of Chongqing)

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 KY202583

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

重庆市沙坪坝区人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shapingba District People's Hospital of Chongqing

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-30 00:00:00

伦理委员会联系人：

胡永娇

Contact Name of the ethic committee：

HU Yongjiao

伦理委员会联系地址：

中国重庆市沙坪坝区井口街道嘉朗路2号

Contact Address of the ethic committee：

No. 2, Jialang Road, Jingkou Subdistrict, Shapingba District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 6554 2958

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

重庆大学附属沙坪坝医院（重庆市沙坪坝区人民医院）

Primary sponsor：

Shapingba Hospital affiliated to Chongqing University(Shapingba District People's Hospital of Chongqing)

研究实施负责（组长）单位地址：

中国重庆市沙坪坝区井口街道嘉朗路2号

Primary sponsor's address：

No. 2, Jialang Road, Jingkou Subdistrict, Shapingba District, Chongqing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

渝中区

Country：

China

Province：

Chongqing

City：

Yuzhong District

单位(医院)：

重庆市妇幼卫生学会

具体地址：

中国重庆市渝中区双钢路3号科协大厦5楼506号

Institution
hospital：

Chongqing Maternal and Child Health Association

Address：

506, 5th Floor, Science and Technology Association Building, No. 3, Shuanggang Road, Yuzhong District, Chongqing, China

经费或物资来源：

重庆市妇幼卫生学会科研基金管理委员会营养与健康专项基金重点项目

Source(s) of funding：

Key Project of Nutrition and Health Special Fund, Scientific Research Fund Management Committee of Chongqing Maternal and Child Health Association.(No.CQMCHA-NH2025-03)

研究疾病：

肥胖（儿童肥胖 / 单纯性肥胖）  

Target disease：

Obesity (Childhood Obesity)

研究疾病代码：

E66.0

Target disease code：

E66.0

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在评估 “家校医社联动” 模式对 6-12 岁肥胖儿童实施运动 - 营养综合干预的短期及中长期效果。具体目标包括：改善儿童体成分（BMI、体脂率）、促进健康生活方式养成、提高自我管理能力，并探索该模式在社区及学校实施的可行性与依从性。  

Objectives of Study：

This study aims to evaluate the short-term and long-term effects of a comprehensive exercise-nutrition intervention on children with obesity aged 6-12 years under the "family-school-medical-community linkage" model. The specific objectives include improving body composition (BMI, body fat percentage), promoting healthy lifestyles, enhancing self-management skills, and exploring the feasibility and compliance of this model in community and school settings.

药物成份或治疗方案详述：

本研究为非药物干预研究。主要干预方案包括：1. 运动干预：制定个体化中低强度有氧运动及抗阻运动方案，由专业康复治疗师指导；2. 营养干预：由营养师制定个性化膳食食谱，控制宏量营养素配比；3. “家校医社” 联动管理：通过医院、学校、家庭及社区多方协作，定期监测随访，保障干预依从性。 

Description for medicine or protocol of treatment in detail：

This is a non-pharmacological intervention study. The main intervention protocols include: 1. Exercise Intervention: Individualized moderate-to-low intensity aerobic and resistance exercise programs guided by professional rehabilitation therapists; 2. Nutritional Intervention: Personalized dietary recipes formulated by dietitians to control macronutrient ratio; 3. "Family-School-Medical-Community" Linkage Management: Regular monitoring and follow-up through multi-dimensional collaboration to ensure intervention compliance. 

纳入标准：

第一部分： 1.年龄6-12岁，BMI≥同性别年龄第95百分位（参照《中国儿童肥胖诊断标准》）； 2.常住重庆市主城区≥6个月，且未来1年无迁居计划； 3.监护人签署知情同意书，儿童本人知情同意。 第二部分： 1. 符合第一部分横断面调查的纳入标准（6-12 岁、BMI≥同性别年龄第 95 百分位、常住重庆市主城区≥6 个月、监护人及儿童知情同意）； 2. 未参与其他肥胖干预研究，且干预期间无迁居计划； 3. 家庭、学校均同意配合协同治理体系的实施。

Inclusion criteria

Part 1: 1. Age 6-12 years old, BMI >= 95th percentile for the same gender and age (refer to "Chinese Criteria for Diagnosing Childhood Obesity"); 2. Resided in the main urban area of Chongqing for ≥ 6 months and has no relocation plan in the next year; 3. Guardians signed the informed consent form, and the child also gave informed consent. Part 2: 1. Meets the inclusion criteria of the cross-sectional survey in Part 1 (6-12 years old, BMI >= 95th percentile for the same gender and age, residing in the main urban area of Chongqing for >= 6 months, guardians and child gave informed consent); 2. Did not participate in other obesity intervention studies, and had no relocation plan during the intervention period; 3. Both the family and the school agreed to cooperate in the implementation of the collaborative governance system.

排除标准：

第一部分： 1.继发性肥胖（如内分泌疾病、药物性肥胖）； 2.严重心、肝、肾功能不全或运动禁忌证； 3.参与其他干预研究或近期接受减肥治疗； 4.存在认知障碍或精神疾病无法配合评估。 第二部分： 1. 符合第一部分横断面调查的排除标准（继发性肥胖、严重脏器疾病、运动禁忌证、认知 / 精神障碍等）； 2. 监护人或儿童无法配合干预流程（如长期缺席干预活动、拒绝完成评估）； 3. 随访期间计划迁居或退出研究。

Exclusion criteria：

Part 1: 1. Secondary obesity (such as endocrine disorders, drug-induced obesity); 2. Severe dysfunction of heart, liver, or kidney or contraindications for exercise; 3. Participating in other intervention studies or having received weight loss treatment recently; 4. Having cognitive impairment or mental illness that prevents cooperation in the assessment. Part 2: 1. Meeting the exclusion criteria of the cross-sectional survey in Part 1 (secondary obesity, severe organ diseases, exercise contraindications, cognitive/mental disorders, etc.); 2. The guardian or the child is unable to cooperate with the intervention process (such as long-term absence from the intervention activities, refusal to complete the assessment); 3. During the follow-up period, planning to relocate or withdraw from the study.

研究实施时间：

Study execute time：

从 From 2026-03-20 00:00:00至 To 2028-11-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-15 00:00:00 至 To 2027-01-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 80

Group：

Intervention Group

Sample size：

干预措施：

运动营养综合干预

干预措施代码：

 C01&D05

Intervention：

Exercise-Nutrition Combined Intervention

Intervention code：

组别：

对照组

样本量：

 80

Group：

Control Group

Sample size：

干预措施：

常规健康宣教为每3个月开展1次线下宣讲，发放科普手册1份，仅告知基础饮食、运动注意事项，不提供个性化指导及联动督导。

干预措施代码：

Intervention：

Regular health education consists of offline lectures held once every 3 months, with 1 copy of popular science manual distributed each time. Only basic dietary and exercise precautions are informed, and no personalized guidance or joint supervision is provided.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

 沙坪坝区 

Country：

China

Province：

Chongqing

City：

Shapingba District

单位(医院)：

 重庆大学附属沙坪坝医院（重庆市沙坪坝区人民医院） 

单位级别：

 三级 

Institution
hospital：

Shapingba Hospital Affiliated to Chongqing University (Shapingba District People's Hospital of Chongqing)

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

BMI z 评分变化

指标类型：

主要指标

Outcome：

Change in BMI z-score

Type：

Primary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

采用身高体重仪测量身高、体重，计算 BMI 并转换为同年龄同性别 z 评分

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Measured height and weight using a stadiometer and scale, calculated BMI and converted to age- and gender-specific z-score

指标中文名：

体脂率变化

指标类型：

主要指标

Outcome：

Change in body fat percentage

Type：

Primary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

采用生物电阻抗分析法（BIA）测量体脂率

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Measured body fat percentage using bioelectrical impedance analysis (BIA)

指标中文名：

腰围变化

指标类型：

次要指标

Outcome：

Change in waist circumference

Type：

Secondary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

采用软尺测量腰围，精确到 0.1 cm

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Measured waist circumference using a flexible tape, accurate to 0.1 cm

指标中文名：

代谢指标（空腹血糖、血脂、维生素D）变化

指标类型：

主要指标

Outcome：

Changes in metabolic indicators (fasting blood glucose, blood lipid, vitamin D)

Type：

Primary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

空腹采集静脉血，由第三方实验室检测空腹血糖、总胆固醇、甘油三酯、HDL-C、LDL-C 及血清 25 - 羟维生素 D 水平

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Fasting venous blood samples were collected, and fasting blood glucose, total cholesterol, triglycerides, HDL-C, LDL-C, and serum 25-hydroxyvitamin D levels were tested by a third-party laboratory

指标中文名：

中等强度运动时间变化

指标类型：

次要指标

Outcome：

Change in moderate-intensity physical activity time

Type：

Secondary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

采用国际体力活动问卷（IPAQ）短卷进行回顾性调查，计算每周中等强度运动时间

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Assessed via the short form of the International Physical Activity Questionnaire (IPAQ) to calculate weekly moderate-intensity physical activity time

指标中文名：

膳食行为与饮食结构评分变化

指标类型：

次要指标

Outcome：

Change in dietary behavior and structure score

Type：

Secondary indicator

测量时间点：

干预前、干预后 12 个月

测量方法：

采用半定量食物频率问卷（FFQ）评估膳食结构与饮食行为，计算评分

Measure time point of outcome：

Baseline, 12 months post-intervention

Measure method：

Assessed via a semi-quantitative food frequency questionnaire (FFQ) to evaluate dietary structure and behavior, and calculate the score

指标中文名：

干预依从性

指标类型：

次要指标

Outcome：

Intervention adherence

Type：

Secondary indicator

测量时间点：

干预期间每 3 个月、干预结束时

测量方法：

通过随访记录、活动打卡率及依从性问卷评估

Measure time point of outcome：

Every 3 months during intervention, at the end of intervention

Measure method：

Assessed via follow-up records, activity check-in rates, and adherence questionnaires

指标中文名：

干预满意度

指标类型：

次要指标

Outcome：

Intervention satisfaction

Type：

Secondary indicator

测量时间点：

干预结束时

测量方法：

采用自制满意度问卷评估儿童及监护人对干预方案的满意度

Measure time point of outcome：

At the end of intervention

Measure method：

Assessed via a self-designed satisfaction questionnaire to evaluate the satisfaction of children and guardians with the intervention program

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

Destruction

Fate of sample：

Destruction after use  

Note：

Samples will be destroyed as medical waste after testing, no long-term storage

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 12 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究统计师（或研究护士）采用 SPSS 软件 产生随机数字序列，按受试者入组顺序进行随机分组，分配至干预组或对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random sequence was generated by a statistician using SPSS software. Subjects were randomly assigned to either the intervention group or the control group according to the order of enrollment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究为生活方式干预研究，无法对受试者、干预实施者设盲，仅对结局评估者和统计分析人员实施盲法。

Blinding：

This is a lifestyle intervention study; blinding of participants and intervention providers is not feasible. Blinding was only implemented for outcome assessors and statistical analysts.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

研究结束并发表论文后，将通过 figshare / Dryad / 期刊指定的学术数据平台，共享去标识化的原始个体数据，数据仅限用于非商业性学术研究，共享期限为论文发表后至少 5 年。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

After publication of the study results, de-identified individual participant data will be shared via academic data platforms such as figshare, Dryad, or the journal-specified repository. The data will be made available for non-commercial academic research purposes only, for a minimum of 5 years after publication.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表（CRF）：设计标准化的电子病例报告表，统一收集受试者的基线资料、体格检查指标、实验室检测结果及干预依从性记录。 电子数据采集系统（EDC）：采用 ResMan 系统 作为基于互联网的电子数据采集平台。研究人员通过 ResMan 系统实时在线录入数据，系统自动进行逻辑核查（如范围核查、一致性检查），以确保数据录入的准确性和完整性。数据录入完成后由研究者进行审核锁定。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management consist of two parts: Case Report Form (CRF): A standardized electronic CRF was designed to collect baseline characteristics, physical examination results, laboratory tests, and intervention adherence records. Electronic Data Capture (EDC): ResMan system, an internet-based EDC platform, was adopted for real-time data entry. Researchers input data online into ResMan, which incorporated automatic logic checks (e.g., range and consistency checks) to ensure data accuracy and integrity. Data were audited and locked by investigators after entry.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-07 08:57:08