The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion

Not Applicable

Completed

• Conditions: Family Caregiving; Infant Health; Growth; Nutrition; Cognition

• Registration Number: NCT06933316
• Lead Sponsor: Xiaoqi Lin

Brief Summary

The FIC model effectively promotes infant growth, improves nutrition, reduces disease risk, and supports early cognitive and psychological development while enhancing parental caregiving skills, demonstrating strong clinical value.

Detailed Description

This study explored the effects of the family-integrated care (FIC) model on growth, nutrition, disease incidence, and early cognitive and psychological development in infants aged 6-18 months. A total of 158 full-term infants were randomly assigned to an intervention group (n=79) or a control group (n=79). The control group received routine health guidance, while the intervention group received additional FIC-based care, including individualized health plans, education, daily care guidance, dietary recommendations, micronutrient supplementation, early intervention, growth monitoring, and vaccination support. Outcomes assessed at baseline and six months post-intervention included growth indices (weight, height, head circumference), nutritional markers (hemoglobin, vitamin D), disease incidence (respiratory infections, gastrointestinal dysfunction, eczema), and Bayley Scales of Infant Development scores. Parental adherence, satisfaction, and caregiving competency were also evaluated.

Study Timeline

• Study Start: 2022-03-13
• Primary Completion: 2023-04-25
• Study Completion: 2024-08-19
• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

1. Infants born in our hospital who undergo regular check-ups in the pediatric healthcare department.
2. Age between 6 and 18 months.
3. Complete and comprehensive clinical data.
4. Full-term birth.
5. Families voluntarily participate and sign informed consent.
6. Parents are in good health and have time to accompany their children daily.

Exclusion Criteria

1. Congenital diseases.
2. Infectious diseases.
3. Familial hereditary diseases.
4. Abnormal conditions during pregnancy or perinatal period.
5. Missing clinical data.
6. No willingness to participate in this study.
7. Abnormal physical or intellectual development of the infant.
8. Intellectual disabilities of the guardians. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion	5 months	The FIC model effectively promotes infant growth, improves nutrition, reduces disease risk, and supports early cognitive and psychological development while enhancing parental caregiving skills, demonstrating strong clinical value.

Trial Locations

Locations (1)

Nanchong Maternal and Child Health and Family Planning Service Center; 🇨🇳 Nanchong, China