Breastfeeding Clinical Trial
Official title:
Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
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Status | Withdrawn |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 |
Verified date | February 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center - with Piedmont Health Services, Inc. | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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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