GrowWell - Responsive Bottle Feeding

NCT06319807 | Completed

• 1 other identifier: IRB00110194
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Bottle Feeding

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Satisfaction Scores - Acceptability

  Week 12

• Satisfaction Scores - Frequency

  Week 12

• Satisfaction Scores - Timing

  Week 12

Study Arms (2)

Digital Health Intervention

EXPERIMENTAL

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

Safety Control

ACTIVE COMPARATOR

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

Interventions

Digital Health Intervention BEHAVIORAL

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.

Digital Health Intervention

Safety Control BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Melissa C Kay, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Sarah M Shelton, BSN

  Atrium Health Wake Forest Baptist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: October 28, 2024
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)