GrowWell - Responsive Bottle Feeding

Bottle Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319807
• Other study ID #: IRB00110194
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Melissa C Kay, PhD
• Phone: 7812493062
• Email: mekay[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 <=1 month old

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

• documented dementia

• subjects who do not have the capacity to give legally effective consent

• agree to video recording of an infant feeding in their home

• any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)

Related Conditions & MeSH terms

• Bottle Feeding

Intervention

Behavioral:
• Digital 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.
• Safety 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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement - average text message completion rate	Engagement will be assessed by reporting the average text message completion rate over the 12-week intervention period.	Week 12
Secondary	Satisfaction Scores - Acceptability	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.	Week 12
Secondary	Satisfaction Scores - Frequency	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.	Week 12
Secondary	Satisfaction Scores - Timing	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.	Week 12