NCT04108533

Brief Summary

The objective of this study is to determine if text-based breastfeeding support improves breastfeeding initiation, exclusivity, and duration when compared to usual postpartum care. All women without a contraindication to breastfeeding and access to a mobile phone with unlimited text messaging capability who deliver a healthy term neonate will be eligible for inclusion. Consented women will be randomized to either text-based breastfeeding support using the Way to Health platform or usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

September 25, 2019

Last Update Submit

August 31, 2021

Conditions

BreastfeedingBreastfeeding, ExclusivePostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Exclusivity

    Exclusive breastfeeding

    6 weeks postpartum

Secondary Outcomes (5)

  • Any Breastfeeding

    6 weeks postpartum

  • Duration

    6 weeks postpartum

  • Formula

    6 weeks postpartum

  • Compliance

    6 weeks postpartum

  • Mood

    2 and 6 weeks postpartum

Study Arms (2)

Text-Based Support

EXPERIMENTAL

Text-Based Support - Women randomized to this arm will receive text-based support via the Way to Health platform as described below. Supportive texts - Encouraging text messages with prompts to ask questions will be sent twice weekly during the first four weeks postpartum and once weekly thereafter for the remaining two weeks of the program Inquiry texts - Questions regarding infant feeding with prompts to answer will be sent three times weekly during the first two weeks postpartum and twice weekly thereafter for the remaining 4 weeks of the program. PHQ2 text - Women will be sent the PHQ2 at 2 weeks and 6 weeks postpartum to assess mood symptoms. Women in this group will also have the option to send a text with a question or concern at any time during the study. Weekdays from 8am to 5 pm these will be fielded by a trained obstetrician. If a text is received after-hours or on the weekend, women will be instructed to reach out to their primary OBGYN provider.

Behavioral: Text-Based Support

Usual Care

NO INTERVENTION

Usual care - Women randomized to this arm will receive usual postpartum care with the following exceptions: Inquiry texts- Questions regarding infant feeding with prompts to answer will be sent once weekly for all 6 weeks of the program. PHQ2 text - Women will be sent the PHQ2 at 2 weeks and 6 weeks postpartum to assess mood symptoms. Women in this group will be directed to their physician with any questions or concerns during the study period.

Interventions

Text-Based SupportBEHAVIORAL

Text-based breastfeeding support as described in arm/group descriptions

Text-Based Support

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age
  • English-speaking
  • Own a cellular phone with unlimited text-messaging
  • Singleton gestation consented at 34-36 weeks of pregnancy
  • Willing and able to sign consent form

You may not qualify if:

  • Contraindication to breastfeeding
  • Delivery of infant requiring ICN admission
  • Physician discretion that patient will be unable to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Bender W, Levine L, Durnwald C. Text Message-Based Breastfeeding Support Compared With Usual Care: A Randomized Controlled Trial. Obstet Gynecol. 2022 Nov 1;140(5):853-860. doi: 10.1097/AOG.0000000000004961. Epub 2022 Oct 5.

    PMID: 36201773DERIVED

MeSH Terms

Conditions

Breast FeedingDepression, Postpartum

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 30, 2019

Study Start

January 6, 2020

Primary Completion

January 20, 2021

Study Completion

March 30, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)