The institutional review board at Florida State University approved this study (STUDY00002895).

The Obesity-Related Behavioral Intervention Trials (ORBIT) model is used to guide the proposed study [30]. The ORBIT model uses an iterative process and was chosen because the LEIFc intervention is behavioral in nature, in the early stage of development, and focused on prevention of a chronic disease [30]. Testing fidelity and feasibility of the LEIFc intervention study falls into phase I of the ORBIT model as the intervention has been designed but needs to be refined based on preliminary testing. The findings from this initial study will provide the foundation to move to phase II and conduct a proof-of-concept trail.

This study uses a pre-post quasi-experimental design with no control group to examine the feasibility, fidelity, and social validity of the LEIFc intervention. The intervention was developed based on existing literature regarding enablers and barriers to the use of responsive feeding by caregivers and communication cues present early in life. The multicomponent LEIFc intervention involves maternal education on responsive feeding practices and mother-infant communication while using a family-guided caregiver coaching approach called SS-OO-PP-RR (“super,” Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review) during feeding sessions [31,32]. The SS-OO-PP-RR approach was developed based on adult learning theory and has been successfully used with parents and childcare providers to promote development across domains in infants and young children [31-33]. For the LEIFc intervention, SS-OO-PP-RR was modified to be specific to communication during feeding to promote responsive feeding (Textbox 2). It is used as a guide for the interventionist during the coaching session but will also be used to evaluate the fidelity of the intervention. The objective measure of responsive feeding will occur through video recording of feeding sessions between mothers and infants. Videos will be coded before the intervention and then after 2 coaching sessions between the interventionist and the mother during a feeding session. The subjective measure of responsive feeding will be collected via a self-report questionnaire completed by mothers before and after the intervention study visits.

Mothers of any parity will be recruited from community settings during the third trimester (28 weeks and beyond) of a healthy pregnancy. To be eligible, mothers need to be aged 18 years or older, able to read and speak English, and agree to video recording of an infant feeding in their home. Any medical or congenital condition in the fetus that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate) will be excluded. Mothers will be enrolled in the third trimester and then screened again after the birth of the infant to ensure that mother and infant remain eligible to participate.

An interventionist will be recruited to deliver the LEIFc intervention in the homes of new mothers. He or she will ideally have a background in maternal-child health and may be a nurse, social worker, speech-language pathologist, dietician, or early child development specialist. The interventionist will be trained on the SS-OO-PP-RR approach and the LEIFc protocol. Because the purpose of this study is to test the fidelity and feasibility of the intervention, feedback from the interventionist will be sought as part of the research protocol.

Eligible mothers will be identified through community settings such as obstetrician offices, prenatal parenting or birth classes, social media forums that pregnant moms may frequent, and word of mouth. If eligible and interested in the study, study personnel will consent mothers for the study. Once enrolled in the study, the interventionist will implement each study visit (Table 1). Study visit 1 is conducted when the mother is in the third trimester of pregnancy. Written material on infant feeding and infant cues of hunger and satiety is provided. Additionally, 2 short videos, one on infant hunger cues and the second on infant satiety cues, are watched with the interventionist and the mother. Any questions on feeding or communication are answered by the interventionist. Study visit 2 is conducted when the infant is approximately 1 month old. At this visit, a video recording of a feeding session between the mother and the infant is taken with no interaction with the interventionist. The feeding can be from the breast or from the bottle (with breastmilk or formula). Study visits 3 (at infant age of 2 months) and 4 (at infant age of 3 months) are the intervention study visits. At each visit, the interventionist will use the SS-OO-PP-RR tool to coach the mother through the feeding to identify hunger and satiety cues and discuss ways to respond. Each of these visits is also video recorded. The final study visit is at infant age of 4 months when another video recording of the infant feeding session is taken with no coaching from the interventionist.

At study visit 1, demographic data are collected along with the mother’s prenatal plans for infant feeding. At study visit 2, birth history is collected along with infant feeding practices, and the mother completes the Infant Feeding Questionnaire (IFQ). During study visits 3 and 4, infant feeding practices are collected. At study visit 5, the mother completes the IFQ and provides feedback on the study itself through a series of qualitative questions.

The primary outcome in this study is the use of responsive feeding. This will be measured before (study visit 2) and after (study visit 5) intervention. Data are obtained subjectively through evaluation of the IFQ and objectively through a video review. The IFQ will provide a subjective measure of responsive feeding. This 20-item self-report tool has been validated for use in mothers of infants [29,34,35]. Likert-type scoring is used; higher scores indicate a stronger measure of the construct. Three subscales will be used to measure responsive feeding: use of food to calm, use of food to soothe, and awareness of infant cues.

The objective measure of responsive feeding will be collected via coding of the video session before and after intervention. The research team developed a coding scheme to capture both mother and infant behaviors during the feeding interactions. The coding scheme was adapted from the Responsiveness to Child Feeding Cues Scale [36] to define specific, discrete maternal behaviors that relate to responding to infant hunger and satiety cues as well as early infant communication acts. Infant behaviors are coded for hunger, satiety, and early communication acts. Research assistants will be trained on the coding scheme and will use existing videos to code with a goal of at least 85% agreement achieved to confirm inter-rater reliability. The coding scheme developed by the team will be used to code the feeding interactions for study visits 2 and 5. Videos will be coded for the number and rate of maternal utterances directed toward the child and responsiveness to the child’s vocalizations using the Noldus Observer XT software. The percentage of the interactions spent jointly engaged between the mother and the infant will also be coded.

Infant feeding practices, demographic characteristics (ie, maternal age, marital status, education level, and race and ethnicity), and maternal depression will be considered as covariates. Initiation and duration of breastfeeding and age at complementary food introduction will be extracted from data and tabulated into variables: duration of breastfeeding (any and exclusive) calculated in weeks and age at complementary food introduction calculated in weeks. Demographic data are collected at study visit 1, infant feeding practices at study visits 2 through 5, and maternal depression (via the Patient Health Questionnaire-9) at study visits 2 through 5.

Power analysis for the matched-pair t test was conducted. With the lower limit of the medium effect size of 0.5 [37], sample sizes of 27 and 36 provided 80% and 90% power, respectively, under 1-sided directional null hypothesis and the nominal significance rate of .05. We will aim to enroll 30 participants for this feasibility and fidelity study.

Once data are clean, descriptive statistics will be computed and examined. For the primary outcome, benefit will be determined by an increase in responsive feeding codes pre-post SS-OO-PP-RR coaching sessions (visits 2 and 5). IFQ subscale scores will be analyzed using matched sample t tests for pre-post coaching sessions to determine the benefit of the intervention. If the assumptions of statistical tests are not clearly met, the Mann-Whitney U test would be considered as an alternative. In a future pilot randomized controlled trial (RCT), analysis of covariance (ANCOVA) will be conducted where the difference between treatment and control groups for the postmeasure is examined with the premeasure as a covariate. The use of ANCOVA provides a statistical control in addition to the design control for the premeasure via random assignment in the RCT.

Although data collection for this study is ongoing, it is anticipated that the LEIFc intervention will be feasible to implement with and socially acceptable to mother-infant dyads by a trained interventionist. Additionally, it is hypothesized that fidelity of the intervention would need to be refined to better meet the needs of mother-infant dyads, especially those from high-risk populations (ie, minority groups and low socioeconomic status). Qualitative data collected from mothers (visit 5) and from the interventionist (visits 3 and 4) will be used to refine the intervention. Finally, it is hypothesized that there may be a change in responsive feeding before or after intervention; however, it cannot be attributed to the intervention until tested with a control group, in the future planned RCT.

Childhood obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey (NHANES) found that between 2017 and 2020 (prepandemic), 19.7% of children aged 2-19 years in the United States had obesity [38]. This is up from the previous NHANES data reporting 18.5% of children with obesity [39]. This rise in childhood obesity percentage suggests that efforts in recent years are not enough and more strategies are needed to halt this epidemic. Additionally, there are a higher percentage of children who are non-Hispanic Black, Hispanic, or from families living below the poverty line with obesity (24.8%, 26.2%, and 25.8%, respectively) [38]. Children with obesity are at risk for lifelong cardiometabolic conditions such as hypercholesterolemia, hypertension, and type 2 diabetes [40,41]. Children with obesity are also more likely to have mental health disorders (ie, depression and anxiety) and complications of the pulmonary, orthopedic, and gastrointestinal systems [1,42,43]. The first 1000 days of life, from conception to age 2 years, is a critical period for the development of habits that contribute to one’s weight status later in life, such as dietary preferences and behaviors [3,44-46]. Therefore, interventions implemented during the first 1000 days and targeting infants from high-risk groups (those of minority race and ethnicity and low socioeconomic status) have potential to decrease one’s obesity risk and subsequent complications. The promotion of responsive feeding is one such intervention that could be used to promote healthy infant weight gain and prevent obesity.

Education on and promotion of responsive feeding should begin prenatally and evolve with the developmental of the child [5]. Research has demonstrated that responsive feeding during infancy helps an individual learn to eat in response to their own internal cues opposed to eating on a schedule [8-10]. The development of this eating pattern early in life may promote healthy eating behaviors lifelong, thus contributing to healthy weight status and prevention of cardiometabolic complications [41]. In addition, this early support for maternal-child communication may enhance language development during infancy. Infants’ earliest communication acts relate to signaling hunger cues, and maternal responsiveness to a child’s cues has long been established as an important predictor of later language outcomes [14]. As such, the LEIFc intervention has the potential to support 2 positive outcomes in children—healthy weight gain and positive communication outcomes.

Infant feeding in the first months after birth often occurs in the home, making this an ideal environment to promote responsive feeding [44,46]. Should the LEIFc intervention be successful, implementation in maternal-child home visiting programs would be sought. Maternal, infant, and early childhood home visiting programs, such as Early Head Start and Healthy Start, provide services to families from pregnancy up to the age of 5 years in at-risk communities [47,48]. These programs serve families from low socioeconomic backgrounds that often include those of minority status. Children from these families have higher rates of childhood obesity, cardiometabolic complications, and language delays [38,43]. The implementation of a responsive feeding intervention in these programs has potential to prevent several complications in children who receive this support, making implementation of the LEIFc intervention an important component to maternal-child home visiting program curricula.

The current funded study will test the feasibility and fidelity of the LEIFc intervention in a group of mother-infant dyads. The intervention has potential to promote 2 childhood outcomes: healthy weight gain and early language development. The results of this feasibility study will allow the researchers to refine the intervention and move to phase IIa of the ORBIT model, testing proof of concept of the intervention. If successful, the LEIFc intervention would be expanded to include vulnerable mother-infant dyads enrolled in maternal-child home visiting programs. Once implemented into the curricula of such programs, application and sustainability would be strong.