Development of an Individualized Responsive Feeding Intervention—Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study

Background Responsive infant feeding occurs when a parent recognizes the infant’s cues of hunger or satiety and responds promptly to these cues. It is known to promote healthy dietary patterns and infant weight gain and is recommended as part of the Dietary Guidelines for Americans. However, the use of responsive infant feeding can be challenging for many parents. Research is needed to assist caregivers recognize infant hunger or satiety cues and overcoming barriers to using responsive infant feeding. Objective The Learning Early Infant Feeding Cues (LEIFc) intervention was designed to fill this gap by using a validated coaching approach, SS-OO-PP-RR (“super,” Setting the Stage, Observation and Opportunities, Problem Solving and Planning, Reflection and Review), to promote responsive infant feeding. Guided by the Obesity-Related Behavioral Intervention Trials model, this study aims to test the feasibility and fidelity of the LEIFc intervention in a group of mother-infant dyads. Methods This pre-post quasi-experimental study with no control group will recruit mothers (N=30) in their third trimester (28 weeks and beyond) of pregnancy from community settings. Study visit 1 will occur prenatally in which written and video material on infant feeding and infant hunger and satiety cues is provided. Demographic information and plans for infant feeding are also collected prenatally via self-report surveys. The use of responsive infant feeding via subjective (survey) and objective (video) measures is recorded before (study visit 2, 1 month post partum) and after (study visit 5, 4 months post partum) intervention. Coaching on responsive infant feeding during a feeding session is provided by a trained interventionist using the SS-OO-PP-RR approach at study visits 3 (2 months post partum) and 4 (3 months post partum). Infant feeding practices are recorded via survey, and infant weight and length are measured at each postpartum study visit. Qualitative data on the LEIFc intervention are provided by the interventionist and mother. Infant feeding videos will be coded and tabulated for instances of infant cues and maternal responses. Subjective measures of responsive infant feeding will also be tabulated. The use of responsive infant feeding pre-post intervention will be analyzed using matched t tests. Qualitative data will be examined to guide intervention refinement. Results This study initially began in spring 2020 but was halted because of the COVID-10 pandemic. With new funding, recruitment, enrollment, and data collection began in April 2022 and will continue until April 2023. Conclusions After refinement, the LEIFc intervention will be tested in a pilot randomized controlled trial. The long-term goal is to implement LEIFc in the curricula of federally funded maternal-child home visiting programs that serve vulnerable populations—those that often have infant feeding practices that do not align with recommendations and are less likely to use responsive infant feeding. International Registered Report Identifier (IRRID) DERR1-10.2196/44329


Title: Testing Fidelity and Feasibility of a Responsive Feeding Intervention in a Group of Mother-Infant Dyads
Principal Investigator(s):

OVERALL IMPACT
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact. Overall impact: overall score = _3_

Strengths
• Preventing childhood obesity among Black families is an essential step in achieving health equity.
• Early interventions for children's eating/feeding, including helping parents understand infants eating and food-related cues, are essential.
• The PI is well-prepared to execute the described research, including a team of collaborators with complementary skills who have a history of collaboration.
• The PI describes an appropriate study design with generally well-described procedures and approaches.

Weaknesses
• The absence of an aim focused on intervention acceptability is a missed opportunity.
• Additional detail related to the videotaping and coding of the observational assessment would give greater confidence that high-quality data will be captured and handled appropriately.

SCORED REVIEW CRITERIA
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. 1. Significance: score = _4_

Strengths
• Major: Culturally-tailored interventions in early life feeding/eating are needed to minimize racial inequalities in childhood obesity.
• Moderate: The proposed research is the next essential step. The investigator will ultimately need preliminary data to support extramural funding.

Weaknesses
• Moderate: In-home interventions of any type are exceedingly difficult to scale to achieve population impact ultimately.
• Moderate: It is not clear why the acceptability of the intervention is not studied in this pilot as it is critical to the research program.

Strengths
• Major: PI has been systematically advancing this research, and she has surrounded herself by a competent team of collaborators with needed complementary expertise.
• Moderate: There is evidence the team has successfully worked together.

Strengths
• Moderate: A relatively new intervention focused on helping parents identify and respond to infants' cues related to eating/feeding.

Strengths
• Moderate-to-Major: The investigator describes an appropriate design, reasonably thorough description of procedures, clear description of critical measures.

Weaknesses
• Minor-to-Moderate: High-quality video and audio of the maternal feeding encounters at visits 2 and 5 are critical to project success. More detail on the positioning of the camera, filtering out background noise, and potential participant discomfort being videotaped during breastfeeding could give greater confidence that high-quality data will be obtained.
• Minor-to-Moderate: In lack fashion, more detail on the behavioral coding strategy, previous experience, and plans to maximize inter-coder agreement would give greater confidence these data will be appropriately handled.

Strengths
• A very detailed description of Environmental supports: the PI and team have access to sufficient human, scientific, and social supports to achieve the identified aims.

Weaknesses
• None

OVERALL IMPACT
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Strengths
• Major-An extremely important health challenge, disparities in pediatric obesity and lifelong impact, that the PI has developed a credible intervention for.
• Major-The previous work by the PI and team has allowed development of a novel intervention, and the proof of concept research design is likely to be successful

Weaknesses
• Minor-Because of funding this remains a validation study and awaits further funding for an extensive efficacy study

SCORED REVIEW CRITERIA
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. 1. Significance: score = _2_

Strengths
• Major-Identifies a significant problem with health disparities in pediatric obesity with 2-fold higher rates of obesity in non-Hispanic black and Hispanic children than with non-Hispanic white children; and associated cardiometabolic conditions that are life-long • Identifies critical period for interventions that could modify weight status and reduce obesity during first 1000 days of life, and key approach to address "responsive feeding". • As this is a feasibility study the research design for a pre-post quasi experimental design with no control group is appropriate • The utilization of videos to monitor feeding response with coding and analysis of feeding, along with the IFQ should yield appropriate data for evaluation

Weaknesses
• This is a proof of concept study and will require an extensive efficacy study with a well designed control group to assess strength of intervention on obesity index over a period of time

OVERALL IMPACT
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Strengths
• Addresses a significant social problem, childhood obesity prevalence, in diverse infantmother dyads, focusing on disadvantaged groups.

Weaknesses
• Study design may overestimate impact of the intervention (fidelity, feasibility) because of absence of a control group.

SCORED REVIEW CRITERIA
Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit and give a separate score for each. 1. Significance: score = _2_

Strengths
• Addresses a significant societal issue: childhood obesity with a well-piloted intervention program for mothers.

Strengths
• The PI specializes in pediatric nursing. All investigators are experienced in working with the target populations.

Weaknesses
• Unsure of prior funding and publication experience based on the application. Having CVs for the investigators is needed to generate a rating.

Strengths
• I don't have the background to assess how novel this program is and what other programs like it have been adopted, but it seems well thought out.

Strengths
• Large sample size planned (50 dyads) that helps control for attrition, and well designed visit protocol.

Weaknesses
• Not having a control group weakens the value of the project in terms of applying for external funding. That is, the data are not going to be particularly compelling for reviewers. Taking video may change the responsiveness of the mothers to the intervention (being on their best behavior during a visit and filming) artificially stimulating adherence during a visit. A better design would use a control group and monitor height and weight gain in the control and experimental groups. That way lapses by mothers in unobserved periods could be monitored indirectly (e.g., if no differences are found between the control and experimental groups). The design was apparently tried already as funded by a CC grant but interrupted by Covid. In that part of the proposal, it was implied that the study should be conducted in "non-vulnerable mother-infant dyads to establish fidelity and feasibility." I didn't see screening criteria in the proposal to ensure that vulnerable dyads would be screened out for this intervention or discussion of "management of high risk aspects of the work" (doing it during Covid).

Strengths
• The group has had experience with recruiting the relevant population and FSU has a history of access through Head Start initiatives.

Weaknesses
• We are still in Covid restrictions for the FSU IRB and it would be good to know how interventionists would be recruited and trained to minimize transmission risk (in both directions). Why would this study succeed when the prior one funded by CC failed?

ADDITIONAL COMMENTS TO APPLICANT
Reviewers may provide guidance to the applicant or recommend against resubmission without fundamental revision. Additional Comments to Applicant (Optional) • The proposal looks about ready to modify for an efficacy trial and it wouldn't take too much effort to rewrite and send out for feedback. Has this been done already (perhaps that is the K23 to NICHD mentioned in the potential for extramural funding section)?