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

NCT ID: NCT06933316

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-13

Study Completion Date

2024-08-19

Brief Summary

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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

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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.

Conditions

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Family Caregiving Infant Health Growth Nutrition Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

the intervention group

Intervention Type 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

The control group received routine health guidance

Group Type OTHER

the control group

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

the 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.

Intervention Type OTHER

Eligibility Criteria

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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. -
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiaoqi Lin

OTHER

Sponsor Role lead

Responsible Party

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Xiaoqi Lin

Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nanchong Maternal and Child Health and Family Planning Service Center

Nanchong, , China

Site Status

Countries

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China

Other Identifiers

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No. 2024058

Identifier Type: -

Identifier Source: org_study_id

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