NCT06933316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

April 9, 2025

Last Update Submit

April 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 months

Study Arms (2)

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.

Other: the intervention group

the control group

OTHER

The control group received routine health guidance

Other: the control group

Interventions

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 intervention group

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.

the control group

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanchong Maternal and Child Health and Family Planning Service Center

Nanchong, 637300, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 18, 2025

Study Start

March 13, 2022

Primary Completion

April 25, 2023

Study Completion

August 19, 2024

Last Updated

April 18, 2025

Record last verified: 2025-04

Locations