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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05265845
Other study ID # Pro00109854
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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
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