Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27708
- Duke University Medical Center - with Piedmont Health Services, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
Interactive text messages that include goal setting, tailored feedback, and skills training.
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The intervention aims to support infant feeding decisions and teach responsive feeding strategies.
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Active Comparator: Control
Text4Baby
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Free health and wellness text messages timed to due date through pregnancy and up until the baby's first birthday.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Engagement
Time Frame: 32 weeks gestation to 3 months postpartum
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Percent of text messages responded to as measured by text log.
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32 weeks gestation to 3 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Breastfeeding duration
Time Frame: 0 to 3 months postpartum
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Number of weeks breastfed as measured by patient response.
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0 to 3 months postpartum
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Melissa C Kay, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00109854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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