Digital Health Tools for Bottle Feeding

Overseen By Keren G Ferris

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Other study, Leaving NC, Medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to prevent rapid infant weight gain and reduce obesity risk by helping parents and caregivers adopt responsive bottle-feeding strategies. It uses digital health tools, including personalized motivational messages and targeted skills-training resources, to support healthy feeding habits. Participants will receive daily text messages for 12 weeks, providing feedback and tips on their feeding practices. This trial suits parents or caregivers with infants under 6 weeks old who own a smartphone and can send and receive text messages in English. As an unphased trial, it offers a unique opportunity for parents to contribute to innovative research that could shape future infant feeding practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these digital health tools are safe for bottle feeding?

Previous research has shown that responsive bottle feeding is generally safe. This method involves noticing and reacting to a baby's hunger signals, encouraging feeding when the baby is hungry and not forcing them to finish the bottle. Studies suggest that responsive feeding can make feeding more enjoyable for both parents and babies. Although specific negative effects are not well-documented, the general consensus is that this method is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring digital health tools for bottle feeding because it offers a fresh approach to supporting parents and caregivers. Unlike traditional methods, which often rely on general feeding guidelines and in-person consultations, this digital intervention provides personalized and automated feedback through daily text messages, helping caregivers adjust their feeding practices in real-time. By focusing on tailored behavior change goals and self-monitoring, this method empowers caregivers with actionable solutions and positive reinforcement, addressing common feeding challenges more dynamically. This innovative use of technology could make responsive feeding guidance more accessible and adaptable to individual needs, potentially improving infant feeding experiences and outcomes.

What evidence suggests that this trial's digital health tools for bottle feeding could be effective in preventing rapid infant weight gain?

Research shows that paced bottle-feeding, a component of responsive feeding, can offer benefits similar to breastfeeding by promoting healthier eating habits. Studies indicate that this method reduces the urge to make infants finish their bottles, potentially helping to control weight gain. In this trial, participants in the Digital Health Intervention arm will receive digital health tools to support responsive feeding, which research has found to enhance feeding experiences and outcomes. These tools send personalized messages and feedback, assisting caregivers in adopting better feeding strategies. Overall, responsive feeding with digital health support appears promising for promoting healthy growth in infants. ^{1 6 7 8 9}

Who Is on the Research Team?

Sarah M Shelton, BSN

Principal Investigator

Atrium Health Wake Forest Baptist

Melissa C Kay, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for parents and caregivers from low-income households with infants, who are currently bottle feeding. The study aims to help them adopt responsive feeding strategies using digital health tools.

Inclusion Criteria

Can read and write in English

I have a smartphone and an email address.

My child is 1 month old or younger.

Exclusion Criteria

Participating in a different research study that, in the opinion of the investigator, would conflict or be too problematic if the subject were to participate in this study

Documented dementia

Agree to video recording of an infant feeding in their home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Intervention

Participants receive daily text messages for 12 weeks, including tailored behavior change goals, self-monitoring with feedback, and skills training around responsive feeding.

12 weeks

Daily virtual interactions

Safety Control

Participants receive daily text messages for 12 weeks, focusing on self-efficacy and skills training around infant safety, with self-monitoring and feedback.

12 weeks

Daily virtual interactions

Follow-up

Participants are monitored for engagement and satisfaction with the intervention content, frequency, and timing.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Responsive Bottle Feeding

Trial Overview The GrowWell trial is testing a digital health intervention designed to prevent rapid infant weight gain by providing personalized motivational messages and skills-training resources to support responsive bottle feeding.

How Is the Trial Designed?

Group I: Digital Health Intervention Experimental Treatment 1 Intervention

Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) tips to foster self-efficacy and skills training around responsive feeding - provide fully automated tailored feedback, which will include theory-driven content that aims to normalize common issues and problems, provide active solutions to feeding problems and affirm positive behavior. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to goals in response to a text messaging prompt and will immediately receive tailored feedback and tips.

Group II: Safety Control Active Control 1 Intervention

Participants will receive tips to foster self-efficacy and skills training around infant safety. Participants will receive daily text messages for 12 weeks. Twice a week participants will be asked to self-monitor their adherence to safety goals in response to a text messaging prompt and will immediately receive tailored feedback and tips.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

A systematic review of nine randomized controlled trials involving 593 preterm infants found that responsive feeding, based on hunger cues, may lead to slightly slower weight gain compared to scheduled feeding, with a mean difference of -1.36 g/kg/day.

There is low-quality evidence suggesting that responsive feeding could help preterm infants transition to full oral feeding about 5.5 days earlier than those fed at scheduled intervals, but the overall impact on hospital discharge duration remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive versus scheduled feeding for preterm infants. Watson, J., McGuire, W.[2021]

A new 15-item Responsive Feeding Practices Assessment Tool was developed and validated for mothers and infants aged 6 to 12 months in Sri Lanka, demonstrating good reliability with an intraclass correlation of 0.80.

The tool effectively measures three key aspects of responsive feeding: communication during feeding, appropriate feeding practices, and attentiveness to the child's signals, making it a valuable resource for improving infant feeding practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Responsive Feeding in Sri Lanka: Development of the Responsive Feeding Practices Assessment Tool. Pallewaththa, P., Agampodi, TC., Agampodi, SB., et al.[2021]

Responsive feeding in preterm infants, which involves feeding based on hunger cues rather than scheduled intervals, may lead to slightly slower weight gain but helps infants transition to full oral feeding more quickly, reducing the time from tube to oral feeding by about 5.5 days.

The evidence regarding the overall impact of responsive feeding on important outcomes like growth rates and hospital stay duration is weak and inconsistent, indicating a need for larger, more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive versus scheduled feeding for preterm infants. Watson, J., McGuire, W.[2018]

Implementing cue-based feeding for preterm infants significantly reduced the time to achieve full oral feedings by an average of 7 days for the youngest infants and 6.6 days for slightly older infants, indicating improved feeding efficiency.

The intervention also decreased the length of hospital stays by 4.4 days for the youngest infants and 2.7 days for older infants, while increasing parental involvement in feeding by 80% and 49%, respectively, leading to substantial cost savings for the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Cue-Based Feeding to Improve Preterm Infant Feeding Outcomes and Promote Parents' Involvement. Thomas, T., Goodman, R., Jacob, A., et al.[2021]

Responsive feeding, which focuses on the interactions between parents and children during feeding, is crucial during the complementary feeding stage as children transition to solid foods, yet there are few intervention trials to support its effectiveness.

To improve outcomes in child growth and feeding, more research is needed to clarify measurement and intervention strategies in responsive feeding, emphasizing the importance of healthy mealtime interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive Feeding: Strategies to Promote Healthy Mealtime Interactions. Black, MM., Hurley, KM.[2019]

A cue-based clinical pathway for managing oral feedings in premature infants led to them achieving full oral feeding 6 days earlier than those managed by traditional physician orders, with a significant difference in postmenstrual age (PMA) at the time of achievement (P=0.02).

The study involved 51 preterm infants (28 in the cue-based group and 23 in the control group), and there were no significant differences in gender, gestational age, birth weight, or ventilator days between the two groups, indicating that the results were likely due to the feeding management approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants. Kirk, AT., Alder, SC., King, JD.[2007]

Responsive feeding has been increasingly recognized and incorporated into nutrition policies and guidelines by international agencies and organizations over the past two decades, highlighting its importance in child nutrition and growth.

Despite a lack of extensive effectiveness trials, there is a push for improving the specificity of responsive feeding interventions and developing tailored protocols and support materials to enhance program implementation in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive feeding: implications for policy and program implementation. Engle, PL., Pelto, GH.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0378378224002500

Does paced bottle-feeding improve the quality and ... Paced bottle-feeding is an approach designed to promote responsive bottle-feeding by mimicking the behavioral benefits of breastfeeding.

2. withpower.com withpower.com/trial/phase-feeding-bottle-4-2024-1bd6a

Digital Health Tools for Bottle Feeding · Info for Participants The research on responsive feeding, including cue-based and paced bottle feeding, suggests it is generally safe and may improve feeding experiences and outcomes ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39693774/

Does paced bottle-feeding improve the quality and ... Paced bottle-feeding is an approach designed to promote responsive bottle-feeding by mimicking the behavioral benefits of breastfeeding.

4. jneb.org jneb.org/article/S1499-4046(23)00472-4/fulltext

Knowledge and Use of Paced Bottle-Feeding Among ... Paced bottle-feeding was associated with lower likelihood of one dimension of pressuring feeding practices, encouraging infant bottle-emptying.

5. jandonline.org jandonline.org/article/S2212-2672(21)00304-X/fulltext

Promoting Responsive Bottle-Feeding Within WIC Responsive feeding and parenting during infancy are also associated with various positive behavioral outcomes during later childhood, such as more consistent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6038199/

INSIGHT responsive parenting intervention and infant feeding ... Controlling feeding practices, including pressuring the infant to finish the bottle and using feeding as the default response to any infant ...

7. frontiersin.org frontiersin.org/10.3389/conf.FPUBH.2017.03.00017/event_abstract

Systematic development of an online intervention to ... The aim of this research was to develop an inclusive, online intervention to encourage skin-to-skin contact and responsive feeding.

8. youtube.com youtube.com/watch?v=5hEq2QpQFT8

Responsive bottle feeding This video is designed to give you some helpful tips about bottle feeding your baby whether that's with formula milk or your expressed breast milk.

9. unicef.org.uk unicef.org.uk/babyfriendly/wp-content/uploads/sites/2/2019/04/Infant-formula-and-responsive-bottle-feeding.pdf

Infant-formula-and-responsive-bottle-feeding. ... Feed your baby when they show signs of being hungry. Cues can include your baby moving their head, opening their mouth and sucking on their fingers.