Learning Early Infant Feeding Cues
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age2+
SponsorFlorida State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Learning Early Infant Feeding Cues
BehavioralThe 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.
Treatment groups
39 Participants
are divided into 1 treatment groupGroup A: LEIFc InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre (infant age of 2 weeks) and post (infant age of 6 weeks) intervention.Secondary outcomes
1
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.
Time frame
Infant age of 2 weeks to 6 months.2
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.
Time frame
weeks or months since birth3
Duration of any breastfeeding
Current infant feeding practices are collected at each study visit. Duration of any breastfeeding will be tabulated into a variable.
Time frame
weeks or months since birthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: