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Completed

NCT Number: NCT06933316

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

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.

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Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanchong Maternal and Child Health and Family Planning Service Center

Nanchong, 637300, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Congenital diseases.
  • Infectious diseases.
  • Familial hereditary diseases.
  • Abnormal conditions during pregnancy or perinatal period.
  • Missing clinical data.
  • No willingness to participate in this study.
  • Abnormal physical or intellectual development of the infant.
  • Intellectual disabilities of the guardians. -

Treatment and study plan

The intervention group

Other

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.

The control group

Other

Infants receive routine healthcare guidance provided by pediatric healthcare professionals. This includes regular check-ups scheduled via phone appointments, general health consultations, vaccinations according to regulations, and tailored feeding and parenting guidance based on examination results.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xiaoqi Lin

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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