ChiCTR2500115778 版本V1.0 版本创建时间2025/12/31 09:07:48 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：

 ChiCTR2500115778 

最近更新日期：

Date of Last Refreshed on：

 2025-12-31 09:07:45 

注册时间：

Date of Registration：

 2025-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

0~3岁婴幼儿岭南特色食谱的开发及应用推广

Public title：

Development and Promotion of Lingnan-Style Menus for Infants and Young Children Aged 0–3 Years

注册题目简写：

English Acronym：

研究课题的正式科学名称：

0~3岁婴幼儿岭南特色食谱的开发及应用推广

Scientific title：

Development and Promotion of Lingnan-Style Menus for Infants and Young Children Aged 0–3 Years

研究课题代号(代码)：

Study subject ID：

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：

刘佳旺 

研究负责人：

朱艳娜 

Applicant：

Liu Jiawang 

Study leader：

Zhu Yanna 

申请注册联系人电话：

Applicant telephone：

 +86 177 7967 3606

研究负责人电话：

Study leader's
telephone：

+86 136 3240 7152

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：

 liujw85@mail2.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhuyn3@mail.sysu.edu.cn

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：

中国广东省广州市越秀区中山二路74号

研究负责人通讯地址：

中国广东省广州市越秀区中山二路74号

Applicant address：

74 Zhongshan Second Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address：

74 Zhongshan Second Road, Yuexiu District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中山大学公共卫生学院

Applicant's institution：

School of Public Health, Sun Yat-sen University

研究负责人所在单位：

中山大学公共卫生学院

Affiliation of the Leader：

School of Public Health, Sun Yat-sen University

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：

 中大公卫医伦{2025}第119号

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：

中山大学公共卫生学院生物医学研究伦理审查委员会

Name of the ethic committee：

Biomedical Research Ethics Review Committee, School of Public Health, Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-15 00:00:00

伦理委员会联系人：

董光辉

Contact Name of the ethic committee：

Dong Guanghui

伦理委员会联系地址：

中国广东省广州市越秀区中山二路74号

Contact Address of the ethic committee：

74 Zhongshan Second Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8733 5447

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：

中山大学公共卫生学院

Primary sponsor：

School of Public Health, Sun Yat-sen University

研究实施负责（组长）单位地址：

中国广东省广州市越秀区中山二路74号

Primary sponsor's address：

74 Zhongshan Second Road, Yuexiu District, Guangzhou, Guangdong, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学公共卫生学院

具体地址：

中国广东省广州市越秀区中山二路74号

Institution
hospital：

School of Public Health, Sun Yat-sen University

Address：

74 Zhongshan Second Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

婴幼儿生长发育及营养状况  

Target disease：

Growth, Development, and Nutritional Status of Infants and Young Children

研究疾病代码：

Target disease code：

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

1.打造至少5所科学食谱推广应用的试点托育机构，以托育机构为单位实施科学食谱的推广应用，并评估推广效果； 2.评估食谱干预加健康教育对婴幼儿饮食行为的影响 3.评估食谱干预加健康教育对婴幼儿生长发育、营养状况及神经发育状况的影响 4.探讨饮食行为改善在干预对体格、生长发育及神经发育影响中的中介作用  

Objectives of Study：

1.Establish at least five pilot childcare centers for the promotion and application of scientific recipes, implement the promotion through these centers, and evaluate the effectiveness of the promotion . 2.Evaluate the impact of dietary intervention combined with health education on the eating behaviors of infants and young children . 3.Assess the effects of dietary intervention combined with health education on the growth and development, nutritional status, and neurodevelopment status of infants and young children . 4.Explore the mediating role of improved eating behaviors in the effects of the intervention on physical growth, development, and neurodevelopment .

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.托育机构层面 (1)在广州市正式备案、并持有《托育机构办园许可证》。 (2)可单独招募的婴幼儿人数不少于30名婴幼儿。 (3)配餐设施齐全（标准化厨房、加热设备）或由配餐公司配餐并愿意配合实行科学食谱。 (4)机构管理层同意配合项目组开展样本量招募、资料收集与质量监控。 2.婴幼儿层面 (1)年龄：0–36个月。 (2)在入选托育机构连续托育>=3个月，具备稳定出勤记录。 (3)父母或监护人自愿签署知情同意书，且承诺配合研究测量与随访。 (4)健康状况：经入园前体检，无严重先天性或慢性疾病。

Inclusion criteria

1. Childcare institution–level inclusion criteria (1)The institution is officially registered in Guangzhou and holds a valid License to Operate a Childcare Institution . (2)The institution is able to independently recruit at least 30 infants/young children. (3)Catering arrangements: the facility either has fully equipped on-site catering (standardized kitchen and reheating equipment) or uses an external catering company, and the catering provider is willing to cooperate in implementing the study menus. (4).Institutional management agrees to cooperate with the study team in participant recruitment, data collection, and quality control activities. 2. Infant/child–level inclusion criteria (1).Age: 0–36 months (0–3 years). (2).The child has been continuously enrolled in the selected childcare institution for >= 3 months and has a stable attendance record. (3).Parent(s) or legal guardian(s) voluntarily provide signed informed consent and agree to cooperate with study measurements and follow-up. (4).Health status: Pre-enrollment health screening indicates no serious congenital anomalies or chronic diseases that would contraindicate participation.

排除标准：

1.托育机构层面 (1)已开展过类似科学膳食干预或正参加其他营养干预研究。 (2)近期（过去半年）发生较大管理或安全事故，可能影响研究依从性 2.婴幼儿层面 (1)出生时早产 (< 37?周) 或极低出生体重 (< 2.5?kg)。 (2)既往或现患影响营养吸收或代谢的疾病（如遗传性代谢病、严重消化系统疾病）。 (3)正在参与其他膳食、药物或营养相关干预研究。 (4)家长计划在研究期间将儿童转出本机构或长期（> 2 周）缺勤。

Exclusion criteria：

1. Childcare institution–level inclusion criteria (1).Institutions that have previously implemented similar evidence-based dietary interventions or are currently participating in other nutritional intervention studies. (2).Institutions that have experienced major administrative or safety incidents within the past six months that are likely to affect study adherence or implementation (e.g., major management changes, serious food-safety incidents, temporary closure). 2. Infant/child–level inclusion criteria (1).Preterm birth (< 37 weeks gestation) or very low birth weight (< 2.5 kg) at birth. (2).History or current diagnosis of conditions affecting nutritional absorption or metabolism (e.g. inborn errors of metabolism, severe gastrointestinal disease). (3).Currently participating in other dietary, pharmaceutical, or nutritional intervention studies. (4).Parent(s) plan to transfer the child out of the institution during the study period or anticipate prolonged absence (> 2 weeks).

研究实施时间：

Study execute time：

从 From 2025-12-31 00:00:00至 To 2026-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2026-01-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 180

Group：

Intervention Group

Sample size：

干预措施：

1.“食育”干预：基于前期开发的《岭南地区0-3岁婴幼儿配餐指南》开展食育培训班，面向托育机构人员及婴幼儿家长，指南内容包括：岭南特色食谱设计、辅食添加质地进阶、常见喂养误区、食物安全注意要点及食物交换份法等。 2.“食养”干预：在托育机构应用岭南特色婴幼儿科学食谱，可利用食物交换份法灵活调整食材。食谱经多方专家评估和审核，确保安全与科学。

干预措施代码：

Intervention：

1."Food Education" Intervention: Organize training sessions on food education based on the previously developed Feeding Guidelines for 0-3-Year-Olds in the Lingnan Region. These sessions will target childcare practitioners and parents of infants and young children. The guidelines cover Lingnan-specific recipe design, texture progression in complementary feeding, common feeding misconceptions, key food safety points, and the food exchange portion method. 2. "Dietary Regimen" Intervention: Implement science-based Lingnan-characterized infant and toddler recipes in childcare settings, utilizing the food exchange portion method for flexible ingredient adjustments. The recipes have undergone rigorous evaluation and approval by a multidisciplinary team of experts to ensure safety and scientific validity.

Intervention code：

组别：

对照组

样本量：

 180

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州市妇女儿童医疗中心 

单位级别：

 三甲 

Institution
hospital：

Guangzhou Women and Children's Medical Center

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州市已备案的托育机构（共 12 所） 

单位级别：

 无 

Institution
hospital：

12 registered childcare institutions in Guangzhou

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

体重

指标类型：

主要指标

Outcome：

Body weight

Type：

Primary indicator

测量时间点：

基线和干预结束时

测量方法：

Measure time point of outcome：

Before intervention and at intervention completion

Measure method：

指标中文名：

身高

指标类型：

主要指标

Outcome：

Height

Type：

Primary indicator

测量时间点：

基线和干预结束时

测量方法：

Measure time point of outcome：

Before intervention and at intervention completion

Measure method：

指标中文名：

头围

指标类型：

主要指标

Outcome：

Head circumference

Type：

Primary indicator

测量时间点：

基线和干预结束时

测量方法：

Measure time point of outcome：

Before intervention and at intervention completion

Measure method：

指标中文名：

肠道菌群及代谢物

指标类型：

主要指标

Outcome：

Gut microbiota and metabolites

Type：

Primary indicator

测量时间点：

基线和干预结束时

测量方法：

Measure time point of outcome：

Before intervention and at intervention completion

Measure method：

指标中文名：

问卷调查（入托婴幼儿的年龄、性别、父母文化水平、家庭月收入、出生方式等）

指标类型：

主要指标

Outcome：

Questionnaire Survey (Age and Gender of Infants and Toddlers, Parental Education Level, Monthly Household Income, Mode of Birth, etc.)

Type：

Primary indicator

测量时间点：

基线和干预结束时

测量方法：

Measure time point of outcome：

Before intervention and at intervention completion

Measure method：

指标中文名：

住院／日托观察天数

指标类型：

主要指标

Outcome：

Number of Observation Days (Inpatient / Daycare)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

神经发育（ASQ）量表

指标类型：

主要指标

Outcome：

Neurodevelopmental Assessment Scale (ASQ)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粪便

组织：

Sample Name：

Feces

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 0 岁 years
最大 Max age 3 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）：

采用整群匹配随机对照试验设计，在广州市已备案的托育机构中选择12所托育机构按食堂经营模式、地区、托育机构星级、机构性质进行两两配对，并随机分配至对照组和干预组。为保证随机化的独立性与分配隐藏，本研究由中山大学公共卫生学院临床试验中心的一名独立统计师使用 SAS 9.4 的 PROC SURVEYSELECT 程序生成整群随机序列（区组长度 = 2）。群单元为托育机构（共 12 所），随机化按区属分层进行，以控制区属间的潜在混杂。随机分配的具体实施由一名不直接参与现场工作的统计助理操作，且该助理在独立统计师的监督下完成分配。

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

Using a matched-pair cluster randomized controlled trial (CRT) design, twelve registered childcare institutions in Guangzhou were selected and paired based on their canteen operation mode, geographical location, institutional star rating, and nature of the institution. Each pair was then randomly allocated to either the control group or the intervention group. To ensure independence of randomization and allocation concealment, the cluster randomization sequence was generated by an independent statistician at the Clinical Trials Center, School of Public Health, Sun Yat-sen University, using SAS 9.4 PROC SURVEYSELECT (block size = 2). The unit of clustering was the childcare institution (n = 12), and randomization was stratified by administrative district to control for potential between-district confounding. Allocation was carried out by a statistical assistant who did not take part in fieldwork, under the supervision of the independent statistician. To maintain allocation concealment, the randomization list was withheld from personnel involved in recruitment and on-site implementation until after assignments were made.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本试验为评估者盲、受试者及干预执行者非盲设计。

Blinding：

This trial employs an evaluator-blinded, subject- and intervention-provider-unblinded design.

是否共享原始数据：

IPD sharing

否No

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）：

不共享原始数据

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

IPD will not be shared.

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：

本研究通过自编问卷和现场体格测量采集数据（包括人口学、暴露/行为问卷项、身高体重/上臂围等体格测量值）。问卷以纸质/电子表格形式采集（若为纸质，现场填写后由研究助理录入电子表格）；所有原始数据统一录入 Excel（按标准化变量名与编码）。录入人员经培训并按录入规范操作，关键变量实施双录或 10% 随机核查并由研究负责人复核。数据文件存放于单位受控服务器/加密云盘，启用访问权限与密码保护并定期备份，不对外共享数据。

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

Data will be collected using a study-specific questionnaire and on-site anthropometric measurements (including demographics, exposure/behavior questionnaire items, and anthropometric measures such as height, weight, and mid-upper arm circumference). Questionnaires will be administered on paper or via electronic forms; if paper forms are used, they will be completed on site and subsequently entered into electronic spreadsheets by research assistants. All source data will be consolidated into Excel using standardized variable names and coding. Data entry personnel will be trained and will follow standardized entry procedures; key variables will undergo double data entry or 10% random verification and will be reviewed by the study principal investigator. Data files will be stored on the institutional secure server/encrypted cloud storage with role-based access control, password protection, and regular backups, and will not be shared externally.

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：

  2025-12-31 09:07:45