Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

Not Applicable

Withdrawn

• Conditions: Bottle Feeding; Child Obesity; Breastfeeding
• Interventions: Behavioral: Intervention; Behavioral: Text4Baby

• Registration Number: NCT05265845
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Status Verified: 2024-02
• Study Start: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Interactive text messages that include goal setting, tailored feedback, and skills training.
Control	Text4Baby	Text4Baby

Primary Outcome Measures

Name	Time	Method
Engagement	32 weeks gestation to 3 months postpartum	Percent of text messages responded to as measured by text log.

Secondary Outcome Measures

Name	Time	Method
Breastfeeding duration	0 to 3 months postpartum	Number of weeks breastfed as measured by patient response.

Trial Locations

Locations (1)

Duke University Medical Center - with Piedmont Health Services, Inc.; 🇺🇸 Durham, North Carolina, United States