Back to resultsUsing Digital Health Technologies to Prevent Rapid Infant Weight Gain.
Primary Purpose
Breastfeeding, Bottle Feeding, Child Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Text4Baby
Sponsored by
About this trial
This is an interventional prevention trial for Breastfeeding
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center - with Piedmont Health Services, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Interactive text messages that include goal setting, tailored feedback, and skills training.
Text4Baby
Outcomes
Primary Outcome Measures
Engagement
Percent of text messages responded to as measured by text log.
Secondary Outcome Measures
Breastfeeding duration
Number of weeks breastfed as measured by patient response.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05265845
Brief Title
Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
Official Title
Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Bottle Feeding, Child Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Interactive text messages that include goal setting, tailored feedback, and skills training.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Text4Baby
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
The intervention aims to support infant feeding decisions and teach responsive feeding strategies.
Intervention Type
Behavioral
Intervention Name(s)
Text4Baby
Intervention Description
Free health and wellness text messages timed to due date through pregnancy and up until the baby's first birthday.
Primary Outcome Measure Information:
Title
Engagement
Description
Percent of text messages responded to as measured by text log.
Time Frame
32 weeks gestation to 3 months postpartum
Secondary Outcome Measure Information:
Title
Breastfeeding duration
Description
Number of weeks breastfed as measured by patient response.
Time Frame
0 to 3 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa C Kay, PhD
Phone
919-613-8397
Email
melissa.kay@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Rodriguez, AS
Phone
919-620-4732
Email
javier.rodriguez2@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa C Kay, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center - with Piedmont Health Services, Inc.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Kay, PhD
Phone
919-613-8397
First Name & Middle Initial & Last Name & Degree
Melissa Kay, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
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