Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

NCT05265845 | Withdrawn

• 1 other identifier: Pro00109854
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding; Bottle Feeding; Child Obesity

Outcome Measures

Primary Outcomes (1)

• Engagement

  Percent of text messages responded to as measured by text log.

  32 weeks gestation to 3 months postpartum

Secondary Outcomes (1)

• Breastfeeding duration

  0 to 3 months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Intervention

Control

ACTIVE COMPARATOR

Text4Baby

Behavioral: Text4Baby

Interventions

Intervention BEHAVIORAL

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

Intervention

Text4Baby BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

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

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Breast Feeding; Bottle Feeding; Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Melissa C Kay, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: February 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)