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Behavioral Intervention
Digital Health Intervention for Bottle Feeding
N/A
Waitlist Available
Led By Melissa C Kay, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Study Summary
"This trial aims to use digital health tools to help WIC clinicians prevent rapid weight gain in infants from low-income households. By providing personalized messages and resources, the intervention will assist parents in adopting better feeding
Who is the study for?
This trial is for parents and caregivers from low-income households with infants, who are currently bottle feeding. The study aims to help them adopt responsive feeding strategies using digital health tools.Check my eligibility
What is being tested?
The GrowWell trial is testing a digital health intervention designed to prevent rapid infant weight gain by providing personalized motivational messages and skills-training resources to support responsive bottle feeding.See study design
What are the potential side effects?
Since this trial involves educational and motivational interventions without medical or pharmaceutical components, there are no direct physical side effects expected from participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Engagement - average text message completion rate
Secondary outcome measures
Satisfaction Scores - Acceptability
Satisfaction Scores - Frequency
Satisfaction Scores - Timing
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Health InterventionExperimental Treatment1 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.
Group II: Safety ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,669 Total Patients Enrolled
Melissa C Kay, PhDPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential participants currently able to enroll in this ongoing investigation?
"According to the details on clinicaltrials.gov, patient enrollment for this particular trial is currently closed. The trial was first listed on 5/1/2024 and last revised on 3/19/2024. Despite this study not actively seeking participants, there are four alternative studies presently open for recruitment."
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