Breast FeedingNCT07461038
Effects of Spousal Participation in Breastfeeding Interventions at Different Perinatal Stages on Mothers' Coparenting Cognition and Infant Feeding Patterns
A study testing Parental Involvement in Breastfeeding Support and Maternal-only Breastfeeding Support in people with Breast Feeding and Social Support, run by Sichuan University at 1 site in China.
Trial summary
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear. Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Feeding, Social Support, Coparenting
- What is being tested?
- Parental Involvement in Breastfeeding Support and Maternal-only Breastfeeding Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to 20 Oct 2020
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Married couples, with gestational age between 12 - 14 weeks at enrollment for Groups A and B;
- Planned discharge within 48 hours after delivery;
- Mothers and partners expected to cohabit for ≥6 months postpartum;
- Gestational age at delivery ≥37 weeks;
- No diagnosed psychiatric disorders in either partner;
- Voluntary participation with written informed consent from both mother and partner;
- Neonates with Apgar scores ≥8 at 1, 5, and 10 minutes after birth.
Who cannot join
- Maternal diagnosis of infectious diseases (e.g., HIV, hepatitis B);
- Withdrawal from the study at any stage;
- Failure to complete required questionnaires;
- Loss to follow-up during the study period;
- Concurrent participation in other interventional studies;
- Major fetal anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Spousal Participation in Breastfeeding Interventions at Different Perinatal Stages on Mothers' Coparenting Cognition and Infant Feeding Patterns: A Prospective Quasi-Experimental Study
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear.
Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being.
Read more
Aim: This study aimed to examine the effects of spousal participation in breastfeeding interventions at different perinatal stages on maternal co-parenting perceptions and infant feeding practices for full-term infants.
Methods: Pregnant women who received antenatal care and delivered at our hospital, together with their partners, were recruited and categorized by the timing of partner involvement in breastfeeding activities: both antenatal and postnatal (Group A); antenatal only (Group B); postnatal only (Group C); and no antenatal education but routine postnatal guidance (Group D). Maternal breastfeeding self-efficacy and coparenting perception were assessed at 6, 12, and 24 weeks postpartum.
- Conditions
- Breast Feeding, Social Support, Coparenting
- Being tested
- Parental Involvement in Breastfeeding Support, Maternal-only Breastfeeding Support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Involvement in Breastfeeding SupportBehavioural
Multistage breastfeeding support involving fathers: prenatal education (14-37 weeks gestation, including manuals and videos), intrapartum 'three early' practices (skin-to-skin contact, early suckling, early milk initiation), and postpartum follow-up (48 hours to 24 weeks, including activity records, QR code resources, and weekly follow-up).
Maternal-only Breastfeeding SupportBehavioural
Routine postpartum breastfeeding guidance provided only to mothers (no paternal involvement), including basic breastfeeding skill training and regular follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Full-stage Parental Involvement Group (A) | Experimental | Perinatal (14 weeks gestation to 24 weeks postpartum) parental joint breastfeeding support Receives: Behavioral: Parental Involvement in Breastfeeding Support |
| Prenatal Parental Involvement Group (B) | Experimental | Prenatal (14 weeks gestation to delivery) parental joint breastfeeding support, postpartum maternal-only support Receives: Behavioral: Parental Involvement in Breastfeeding Support |
| Postpartum Parental Involvement Group (C) | Experimental | Prenatal maternal-only support, postpartum (delivery to 24 weeks) parental joint breastfeeding support Receives: Behavioral: Parental Involvement in Breastfeeding Support |
| Maternal-only Support Group (D) | Active comparator | Postpartum maternal-only routine breastfeeding guidance Receives: Behavioral: Maternal-only Breastfeeding Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Breastfeeding Self-Efficacy
Measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). This 14-item scale uses a 5-point response scale (1 = not confident at all, 5 = completely confident), with a total score ranging from 14 to 70. Higher scores indicate stronger breastfeeding self-efficacy. Measured at 6, 12, and 24 weeks postpartum.
Measured: 6 weeks postpartum, 12 weeks postpartum, 24 weeks postpartum
Spousal Involvement Frequency in Breastfeeding
Recorded via a self-designed activity log, including spousal assistance in breastfeeding preparation, positioning, and follow-up.
Measured: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Secondary outcomes (4)
Coparenting Perception Level
Measured by the Brief Coparenting Relationship Scale (Brief-CRS). This 14-item scale uses a 6-point response scale (0 = completely disagree, 6 = completely agree), with a total score ranging from 0 to 84. Higher scores indicate better coparenting coordination between parents. Measured at 6, 12, and 24 weeks postpartum.
Measured: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Breastfeeding Type
Categorized as exclusive breastfeeding, mixed feeding, or formula feeding, based on maternal self-report.
Measured: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Neonatal Weight Gain
Recorded as the change in neonatal body weight (in kilograms) from birth to each follow-up time point, based on clinical follow-up records.
Measured: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Duration of Jaundice
Recorded as the number of days from the onset of neonatal jaundice to its complete resolution, based on clinical follow-up records.
Measured: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start20 Aug 2020
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Run Huang, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461038
- Sponsor's protocol ID
- 20-078
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spousal Participation in Breastfeeding Interventions at Different Perinatal Stages on Mothers' Coparenting Cognition and Infant Feeding Patterns: A Prospective Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07461038
- Acronym / sponsor ID
- 20-078
- Conditions
- Breast Feeding, Social Support, Coparenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 10 Mar 2026 (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.
Problem: While partner support benefits breastfeeding outcomes, its impact across perinatal stages on maternal co-parenting perception is unclear.
Background: Spousal involvement plays a vital role in successful breastfeeding and maternal well-being.
Aim: This study aimed to examine the effects of spousal participation in breastfeeding interventions at different perinatal stages on maternal co-parenting perceptions and infant feeding practices for full-term infants.
Methods: Pregnant women who received antenatal care and delivered at our hospital, together with their partners, were recruited and categorized by the timing of partner involvement in breastfeeding activities: both antenatal and postnatal (Group A); antenatal only (Group B); postnatal only (Group C); and no antenatal education but routine postnatal guidance (Group D). Maternal breastfeeding self-efficacy and coparenting perception were assessed at 6, 12, and 24 weeks postpartum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Full-stage Parental Involvement Group (A) | Experimental | Behavioral: Parental Involvement in Breastfeeding SupportPerinatal (14 weeks gestation to 24 weeks postpartum) parental joint breastfeeding support |
| Prenatal Parental Involvement Group (B) | Experimental | Behavioral: Parental Involvement in Breastfeeding SupportPrenatal (14 weeks gestation to delivery) parental joint breastfeeding support, postpartum maternal-only support |
| Postpartum Parental Involvement Group (C) | Experimental | Behavioral: Parental Involvement in Breastfeeding SupportPrenatal maternal-only support, postpartum (delivery to 24 weeks) parental joint breastfeeding support |
| Maternal-only Support Group (D) | Active comparator | Behavioral: Maternal-only Breastfeeding SupportPostpartum maternal-only routine breastfeeding guidance |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Married couples, with gestational age between 12 - 14 weeks at enrollment for Groups A and B;
- Planned discharge within 48 hours after delivery;
- Mothers and partners expected to cohabit for ≥6 months postpartum;
- Gestational age at delivery ≥37 weeks;
- No diagnosed psychiatric disorders in either partner;
Key exclusion criteria (6 listed)
- Maternal diagnosis of infectious diseases (e.g., HIV, hepatitis B);
- Withdrawal from the study at any stage;
- Failure to complete required questionnaires;
- Loss to follow-up during the study period;
- Concurrent participation in other interventional studies;
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 |
|---|---|---|
| Parental Involvement in Breastfeeding SupportMultistage breastfeeding support involving fathers: prenatal education (14-37 weeks gestation, including manuals and videos), intrapartum 'three early' practices (skin-to-skin contact, early suckling, early milk initiation), and postpartum follow-up (48 hours to 24 weeks, including activity records, QR code resources, and weekly follow-up). | Behavioural | Full-stage Parental Involvement Group (A), Postpartum Parental Involvement Group (C), Prenatal Parental Involvement Group (B) |
| Maternal-only Breastfeeding SupportRoutine postpartum breastfeeding guidance provided only to mothers (no paternal involvement), including basic breastfeeding skill training and regular follow-up. | Behavioural | Maternal-only Support Group (D) |
Primary outcome
Maternal Breastfeeding Self-Efficacy
Time frame: 6 weeks postpartum, 12 weeks postpartum, 24 weeks postpartum
Measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). This 14-item scale uses a 5-point response scale (1 = not confident at all, 5 = completely confident), with a total score ranging from 14 to 70. Higher scores indicate stronger breastfeeding self-efficacy. Measured at 6, 12, and 24 weeks postpartum.
Spousal Involvement Frequency in Breastfeeding
Time frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Recorded via a self-designed activity log, including spousal assistance in breastfeeding preparation, positioning, and follow-up.
4 secondary outcomes
Coparenting Perception Level
Time frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Breastfeeding Type
Time frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Neonatal Weight Gain
Time frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
Duration of Jaundice
Time frame: 6 weeks postpartum; 12 weeks postpartum; 24 weeks postpartum
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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 Parental Involvement in Breastfeeding Support and Maternal-only Breastfeeding Support in people with Breast Feeding and Social Support, run by Sichuan University 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 7 inclusion and 6 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 10 Mar 2026. 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?
Maternal Breastfeeding Self-Efficacy (time frame: 6 weeks postpartum, 12 weeks postpartum, 24 weeks postpartum). The study lists 2 primary outcomes in all. 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 10 Mar 2026.