GrowWell - Responsive Bottle Feeding

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

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.

Study Overview

• Status: Completed
• Conditions: Bottle Feeding
• Intervention / Treatment: Behavioral: Digital Health Intervention; Behavioral: Safety Control

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Health 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.	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.
Active Comparator: Safety Control; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Melissa C Kay, PhD, Wake Forest University Health Sciences; Study Director: Sarah M Shelton, BSN, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: obesity prevention; infant growth; Women, Infants, and Children )WIC)
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Bottle Feeding
• Other Study ID Numbers: IRB00110194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No