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GrowWell - Responsive Bottle Feeding

Using Digital Health Technologies to Prevent Obesity Among Infants of Parents Receiving Nutrition Assistance Benefits.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06319807
Enrollment
69
Registered
2024-03-20
Start date
2024-10-28
Completion date
2025-08-18
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bottle Feeding

Keywords

obesity prevention, Women, Infants, and Children )WIC), infant growth

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

Interventions

BEHAVIORALDigital Health Intervention

Participants will receive: 1) behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. We will use text messaging to administer the intervention pieces. At baseline, each participant will complete a series of surveys to gain background information. Throughout the study participants will report their goal adherence in response to a text messaging prompt and immediately receive tailored feedback. Text messages will be deployed daily with 2 check in messages per week; participants will receive tailored feedback based on their response.

BEHAVIORALSafety Control

Participants will receive: 1) behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. We will use text messaging to administer the intervention pieces. At baseline, each participant will complete a series of surveys to gain background information. Throughout the study participants will report their goal adherence in response to a text messaging prompt and immediately receive tailored feedback. Text messages will be deployed daily with 2 check in messages per week; participants will receive tailored feedback based on their response.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Satisfaction Scores - FrequencyWeek 12Satisfaction 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 - AcceptabilityWeek 12Satisfaction 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 - TimingWeek 12Satisfaction 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026