Responsive FeedingLEIFcNCT06127914
Learning Early Infant Feeding Cues
A study testing Learning Early Infant Feeding Cues in people with Responsive Feeding and Infants, run by Florida State University.
Trial summary
The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. Read more about this study
- Who is it for?
- Ages 2 weeks and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Responsive Feeding, Infants, Weight Gain Trajectory
- What is being tested?
- Learning Early Infant Feeding Cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 weeks and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Maternal Inclusion Criteria
- Pregnant mother in the 3rd trimester (28 weeks or beyond)
- Enrolled in a government-funded maternal-child home visiting program
- Maternal age 18 years or older
- English or Spanish speaking
- Anticipated to have custody of infant after birth
- Healthy pregnancy, no complications that are anticipated to result in a preterm birth or extended hospital stay for mother or infant
Maternal Exclusion Criteria
- Gave birth to multiple fetuses
- Age less than 18 years
- Not fluent in English or Spanish
- Expected to not have custody of the infant after birth
Infant inclusion criteria
- Born as a singleton (not a twin, triplet, etc.) to a mother enrolled in a maternal-child home visiting program
- Born full term (37 weeks or beyond)
Infant exclusion criteria
- Congenital anomaly that may interfere with infant feeding or growth after birth (i.e., Down Syndrome, cleft lip/palate)
- Born preterm (born prior to 37 weeks)
- NICU stay beyond 48 hours
- Infant diagnosis of failure to thrive
- Supplemental oxygen
- Enteral feeding device used for feedings
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads
The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are:
- What are the contributors and barriers to use of responsive infant feeding?
- How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy.
- Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs?
Read more
Participants will be asked to:
- Participate in focus groups to talk about their experiences feeding their baby.
- Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include:
- Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach.
- Agreeing to be video recording during the session when the baby is eating.
- Completing surveys online.
- Conditions
- Responsive Feeding, Infants, Weight Gain Trajectory
- Being tested
- Learning Early Infant Feeding Cues
- Medical subject headings
- Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning Early Infant Feeding CuesBehavioural
The LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assist the mother in making decisions regarding feeding her infant. This will begin with milk based feedings (either breastmilk from breast or bottle, or formula from a bottle), and continue through the transition to solid (complementary) foods.
| Study group | Role | What they receive |
|---|---|---|
| LEIFc Intervention | Experimental | There is only 1 arm of this study. All participants will receive the LEIFc intervention. Receives: Behavioral: Learning Early Infant Feeding Cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive Feeding
Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected. Participants will complete the Infant Feeding Questionnaire to provide a subjective measure of responsive feeding. A feeding session will be video recording then coded for instances of infant cues and maternal response to cues to provide an objective measure of responsive feeding.
Measured: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.
Secondary outcomes (3)
Infant growth trajectory
Infant weight-for-length z-score (WLz) will be calculated from infant weight and length measurements obtained at each study visit. The difference in WLz between infant age of 2 weeks and 6 months will be calculated. Infants will be categorized into 3 growth categories: expected growth (WLz SD change between -0.67 and 0.67, rapid growth > or equal to 0.67, or slow growth < or equal to -0.67.
Measured: Infant age of 2 weeks to 6 months.
Age of complementary food introduction
Current infant feeding practices are collected at each study visit. The infant age (in weeks) at which any foods other than breastmilk or formula were given will be tabulated into a variable.
Measured: weeks or months since birth
Duration of any breastfeeding
Current infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.
Measured: weeks or months since birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Responsive FeedingStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Bahorski, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127914
- Sponsor's protocol ID
- STUDY00004685
- Acronym
- LEIFc
- Status last verified
- Apr 2026
- First submitted
- 8 Nov 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregated dataset of deidentified participant data will be shared with other research. A data use agreement (DUA) will be required. Video data will not be shared.
Publications
Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.
PubMed 36853761
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiphase Project to Improve Use of Responsive Feeding Among Vulnerable Mother-Infant Dyads
- ClinicalTrials.gov ID
- NCT06127914
- Acronym / sponsor ID
- LEIFc / STUDY00004685
- Conditions
- Responsive Feeding, Infants, Weight Gain Trajectory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Nov 2023 (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 goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are:
- What are the contributors and barriers to use of responsive infant feeding?
- How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy.
- Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs?
Participants will be asked to:
- Participate in focus groups to talk about their experiences feeding their baby.
- Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include:
- Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach.
- Agreeing to be video recording during the session when the baby is eating.
- Completing surveys online.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEIFc Intervention | Experimental | Behavioral: Learning Early Infant Feeding CuesThere is only 1 arm of this study. All participants will receive the LEIFc intervention. |
Who may qualify
- Ages
- 2 weeks and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Learning Early Infant Feeding CuesThe LEIFc intervention includes individualized responsive feeding education and promotion using the SS-OO-PP-RR (or "super," Setting the Stage, Observation and Opportunities to Embed, Problem Solving and Planning, Reflection and Review coaching approach as a guide. An interventionists interacts with mother-infant dyads during a feeding session at infant ages of 1, 2, 3, 4, and 5 months and coaches the mother on responsive feeding. In particular infant cues of hunger and fullness and tips to assist the mother in making decisions regarding feeding her infant. This will begin with milk based feedings (either breastmilk from breast or bottle, or formula from a bottle), and continue through the transition to solid (complementary) foods. | Behavioural | LEIFc Intervention |
Primary outcome
Responsive Feeding
Time frame: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.
Subjective (via survey) and objective (via video) measurement of responsive feeding will be collected. Participants will complete the Infant Feeding Questionnaire to provide a subjective measure of responsive feeding. A feeding session will be video recording then coded for instances of infant cues and maternal response to cues to provide an objective measure of responsive feeding.
3 secondary outcomes
Infant growth trajectory
Time frame: Infant age of 2 weeks to 6 months.
Age of complementary food introduction
Time frame: weeks or months since birth
Duration of any breastfeeding
Time frame: weeks or months since birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 36853761Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.
- Individual participant dataSharing planned: Undecided. Aggregated dataset of deidentified participant data will be shared with other research. A data use agreement (DUA) will be required. Video data will not be shared.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Learning Early Infant Feeding Cues in people with Responsive Feeding and Infants, run by Florida State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Bahorski (8506446013, jbahorski@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsive Feeding (time frame: Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127914, which also lists 1 linked publication.
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 27 Apr 2026.