MedPath

GrowWell - Responsive Bottle Feeding

Not Applicable
Recruiting
Conditions
Bottle Feeding
Interventions
Behavioral: Safety Control
Behavioral: Digital Health Intervention
Registration Number
NCT06319807
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

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.

Detailed 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

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
60
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Safety ControlSafety ControlParticipants 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.
Digital Health InterventionDigital Health InterventionParticipants 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.
Primary Outcome Measures
NameTimeMethod
Engagement - average text message completion rateWeek 12

Engagement will be assessed by reporting the average text message completion rate over the 12-week intervention period.

Secondary Outcome Measures
NameTimeMethod
Satisfaction Scores - AcceptabilityWeek 12

Satisfaction with the intervention content - Participants will be asked to complete satisfaction surveys upon study completion to assess the acceptability of the message perceptions about the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.

Satisfaction Scores - FrequencyWeek 12

Satisfaction with the intervention message frequency - Participants will be asked to complete satisfaction surveys upon study completion to assess the frequency of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.

Satisfaction Scores - TimingWeek 12

Satisfaction with the intervention message timing - Participants will be asked to complete satisfaction surveys upon study completion to assess the timing, of the use of digital technologies. There isn't a scale; we will report percentage responding positively to each question.

Trial Locations

Locations (1)

Wake Forest University Health Sciences

🇺🇸

Winston-Salem, North Carolina, United States

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