Family CaregivingNCT06933316
The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion
A study testing the intervention group in people with Family Caregiving and Infant Health, run by Xiaoqi Lin at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Family Caregiving, Infant Health, Growth
- What is being tested?
- the intervention group
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2022to 19 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
China1 site
Nanchong Maternal and Child Health and Family Planning Service Center
Nanchong, 637300
About this study
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.
- Conditions
- Family Caregiving, Infant Health, Growth, Nutrition, Cognition
- Being tested
- the intervention group, the control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the intervention groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: the intervention group |
| the control group | Other | The control group received routine health guidance Receives: Other: the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start13 Mar 2022
- Primary completion25 Apr 2023
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family CaregivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoqi Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaoqi Lin, Nanchong Maternal and Child Health and Family Planning Service Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933316
- Sponsor's protocol ID
- No. 2024058
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion
- ClinicalTrials.gov ID
- NCT06933316
- Acronym / sponsor ID
- No. 2024058
- Conditions
- Family Caregiving, Infant Health, Growth, Nutrition, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Xiaoqi LinUniversity, hospital or other
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Other | Other: the intervention groupthe 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 | Other: the control groupThe control group received routine health guidance |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Congenital diseases.
- Infectious diseases.
- Familial hereditary diseases.
- Abnormal conditions during pregnancy or perinatal period.
- Missing clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the intervention groupthe 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 groupInfants 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. | Other | the control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the intervention group in people with Family Caregiving and Infant Health, run by Xiaoqi Lin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Family-Integrated Care Model on Infant and Toddler Health Promotion (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.