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

69 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Responsive Bottle Feeding, Paced Bottle Feeding, Cue-Based Feeding, Responsive Feeding?

Research shows that cue-based feeding can help premature infants achieve full oral feeding earlier, and responsive feeding is recognized in global nutrition policies for its role in child nutrition and growth. ^{1 2 3 4 5}

Is responsive feeding safe for humans?

The research on responsive feeding, including cue-based and paced bottle feeding, suggests it is generally safe and may improve feeding experiences and outcomes for infants, particularly preterm ones. It focuses on responding to infants' hunger cues, which can enhance satisfaction and growth without noted safety concerns. ^{1 3 4 6 7}

How is the treatment Responsive Bottle Feeding different from other treatments for bottle feeding?

Responsive Bottle Feeding is unique because it focuses on feeding infants based on their hunger and fullness cues rather than on a fixed schedule. This approach can improve the feeding experience for both infants and parents, support better growth and nutrient intake, and potentially lead to earlier hospital discharge for preterm infants. ^{1 3 5 6 7}

What is the purpose of this trial?

The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

Research Team

Sarah M Shelton, BSN

Principal Investigator

Atrium Health Wake Forest Baptist

Melissa C Kay, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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, 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation of Cue-Based Feeding to Improve Preterm Infant Feeding Outcomes and Promote Parents' Involvement. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Measuring Responsive Feeding in Sri Lanka: Development of the Responsive Feeding Practices Assessment Tool. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Responsive Feeding: Strategies to Promote Healthy Mealtime Interactions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Responsive feeding: implications for policy and program implementation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Responsive versus scheduled feeding for preterm infants. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Responsive versus scheduled feeding for preterm infants. [2018]