Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

Breastfeeding Clinical Trial

Official title:

Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05265845
• Other study ID #: Pro00109854
• Status: Withdrawn
• Phase: N/A
• Start date: February 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A digital intervention to provide supplemental infant feeding support to mothers enrolled in WIC. The trial begins prenatally and continues through 3-months postpartum and tests the feasibility and acceptability of a text messaging intervention aimed at increasing responsive bottle feeding as well as breastfeeding duration and exclusivity among mothers enrolled in WIC using evidence-based components such as interactive self-monitoring and feedback.

Recruitment and enrollment never started at Duke for the Intervention represented in this record. The overall status of recruiting and actual start date were previously entered in error.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in WIC, English or Spanish speaking, at least 18 years old, between 18-28 weeks' gestation, and planning to remain enrolled in WIC for 6 months, intention to breastfeed or undecided about breastfeeding, and willingness to send and receive daily text messages.

Exclusion Criteria:

• Postpartum exclusions include infant prematurity (<37 weeks), >3 days in neonatal intensive care unit, major medical problem affecting breastfeeding (i.e., maternal HIV), or birth weight <5 lbs.

Related Conditions & MeSH terms

• Bottle Feeding
• Breastfeeding
• Child Obesity
• Pediatric Obesity
• Weight Gain

Intervention

Behavioral:
• Intervention
The intervention aims to support infant feeding decisions and teach responsive feeding strategies.
• Text4Baby
Free health and wellness text messages timed to due date through pregnancy and up until the baby's first birthday.

Locations

Country	Name	City	State
United States	Duke University Medical Center - with Piedmont Health Services, Inc.	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement	Percent of text messages responded to as measured by text log.	32 weeks gestation to 3 months postpartum
Secondary	Breastfeeding duration	Number of weeks breastfed as measured by patient response.	0 to 3 months postpartum