Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

NCT ID: NCT05265845

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-07-31

Brief Summary

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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

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Conditions

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Breastfeeding Bottle Feeding Child Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

Interactive text messages that include goal setting, tailored feedback, and skills training.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

The intervention aims to support infant feeding decisions and teach responsive feeding strategies.

Control

Text4Baby

Group Type ACTIVE_COMPARATOR

Text4Baby

Intervention Type BEHAVIORAL

Free health and wellness text messages timed to due date through pregnancy and up until the baby's first birthday.

Interventions

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Intervention

The intervention aims to support infant feeding decisions and teach responsive feeding strategies.

Intervention Type BEHAVIORAL

Text4Baby

Free health and wellness text messages timed to due date through pregnancy and up until the baby's first birthday.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa C Kay, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center - with Piedmont Health Services, Inc.

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00109854

Identifier Type: -

Identifier Source: org_study_id

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