GrowWell - Responsive Bottle Feeding

Wake Forest University (WFU)

Status: Completed

Conditions: Bottle Feeding

Treatments: Behavioral: Digital Health Intervention; Behavioral: Safety Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06319807

IRB00110194

Details and patient eligibility

About

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.

Full description

Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.

Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum

Enrollment: 69 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged ≥18 years
• as a smartphone and an email address
• willing to send and receive daily text messages
• can read and write in English
• child is <=6 weeks

Exclusion criteria

• participating in in a different research study that, in the opinion of the investigator, would conflict or would otherwise be too problematic if the subject were to participate in this study
• planning to leave North Carolina in the next 6 months
• subjects who do not have the capacity to give legally effective consent
• any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Digital Health Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Health Intervention

Safety Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Safety Control