CClinicalTrials.gg
CompletedNCT06933316Updated Apr 18, 2025

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

An interventional study of the intervention group and the control group in Family Caregiving, Infant Health and Growth, sponsored by Xiaoqi Lin. Completed at 1 site in China. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Xiaoqi Lin · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Mar 2022, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
158
Allocation
Randomized
Ages
6 Months to 18 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Family Caregiving
  • Infant Health
  • Growth
  • Nutrition
  • Cognition
03

In context

Lead sponsor

This is the only study on the registry with Xiaoqi Lin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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. -
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
158 participants (actual)

Study arms

  • Other
    the intervention group

    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

  • Other
    the control group

    The control group received routine health guidance

    Other: the control group

Interventions

  • Otherthe intervention group

    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.

  • Otherthe control 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.

06

What researchers measure

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.

    Time frame: 5 months

07

Study locations

1 site
  • Nanchong Maternal and Child Health and Family Planning Service Center
    Nanchong, 637300, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06933316
Lead sponsor
Xiaoqi Lin
Responsible party
Xiaoqi Lin (Chief Physician, Nanchong Maternal and Child Health and Family Planning Service Center) — Sponsor-investigator
First posted
Apr 18, 2025
Start date
Mar 13, 2022
Primary completion
Apr 25, 2023
Completion
Aug 19, 2024
Last update
Apr 18, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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