CompletedNot Applicable

Testing LEIFc in the Community

United States29 participantsStarted 2022-04-10

Plain-language summary

The reason that we are doing this research is to teach mothers ways to communicate with their baby during feeding. Understanding signals a baby gives helps mothers know when and how much to feed their baby which will help the baby grow in a healthy way. There are 5 study visits, 1 during pregnancy and 4 after the baby is born. At the first visit participants will watch some videos about feeding babies and be provided with information to read about feeding babies, there is also a questionnaire to complete. After the baby is born, a research team member will come to participants' homes at infant age of 1, 2, 3, and 4 months to videotape an infant feeding session. At the visit when the baby is 2 and 3 months of age, the intervention will occur in which the interventionists will provide coaching about responsive feeding before and during a feeding session. The baby's height and weight will be collected and some questionnaires completed. At the last study visit, a research assistant will ask opened ended questions about the study itself, these questions and participant answers will be audio recorded.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * pregnant in the 3rd trimester (28 weeks or beyond) of a healthy pregnancy * pregnant with a single fetus * 18 years or older * no known complications or genetic anomalies of the infant that would interfere with feeding or growth after birth * English or Spanish speaking Exclusion Criteria: * mother less than 18 years * will not have custody of the infant after birth

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Responsive Infant Feeding

Timeframe: Pre-intervention (infant age 1 month) to post-intervention (infant age 4 months)

Trial details

NCT IDNCT06898190

SponsorFlorida State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Responsive Infant Feeding trials