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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06933316
Enrollment
158
Registered
2025-04-18
Start date
2022-03-13
Completion date
2024-08-19
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition, Family Caregiving, Growth, Infant Health, Nutrition

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.

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.

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.

Sponsors

Xiaoqi Lin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Months
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

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. -

Design outcomes

Primary

MeasureTime frameDescription
The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion5 monthsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026