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Lactation Achievement With Texts at Home (LATcH)

Primary Purpose

Breastfeeding, Breastfeeding, Exclusive, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-Based Support
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • >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

Exclusion Criteria:

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

Sites / Locations

  • Hospital of the University Of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text-Based Support

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Exclusivity
Exclusive breastfeeding

Secondary Outcome Measures

Any Breastfeeding
Any reported breastfeeding
Duration
Duration of breastfeeding
Formula
Rate of formula use
Compliance
Compliance with postpartum visit
Mood
Mood assessment using PHQ-2

Full Information

First Posted
September 25, 2019
Last Updated
August 31, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04108533
Brief Title
Lactation Achievement With Texts at Home
Acronym
LATcH
Official Title
LATcH: Lactation Achievement With Texts at Home
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Breastfeeding is a public health priority. The CDC and WHO, among other professional organizations, have issued the following recommendations with respect to breastmilk. Infants should be exclusively breastfed through the first 6 months of life and continue to receive breastmilk through at least the first year of life. Many women, however, are not meeting these benchmarks even among those who desire to do so. Approximately one quarter of infants are exclusively breastfed at 6 months and a little over 1/3 are still receiving breastmilk at the time of their 1st birthday.1 What looking at these numbers alone miss is the number of women who attempt to breastfeed and do not continue to do so. 83% of women attempt breastfeeding indicating that there is a significant drop off that occurs between delivery and 6 and 12 months of life. While the risk factors for this are vast, lack of education poor socioeconomic status and poor social support are important contributors to breastfeeding problems. Both professional and informal support through family or friends have a significant impact on breastfeeding outcomes. Not all patients, however, have the resources needed to obtain professional support or the family experience necessary to meet their breastfeeding goals. Digital support in other medical specialties have shown success in health outcomes. Multiple international studies have also demonstrated the benefits of text-messaging on breastfeeding rates including improved rates and duration of exclusivity. Thus far, none of these studies have been performed in the United States. Therefore, the aim of this study is to determine if text-based breastfeeding support improves breastfeeding initiation, duration, and exclusivity when compared to usual postpartum care. All women without a contraindication to breastfeeding and access to a mobile phone with unlimited text messaging capability will be approached in the 34-36 week of pregnancy. All consented women will be enrolled in a "run-in" period in which they receive weekly text messages with factual information about breastfeeding. A response is required to one or more of these texts in order to be eligible for randomization at delivery. Upon delivery of a healthy term neonate, women who responded in the "run-in" period will be randomized to either text-based breastfeeding support using the Way to Health platform or usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Breastfeeding, Exclusive, Postpartum Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text-Based Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text-Based Support
Intervention Description
Text-based breastfeeding support as described in arm/group descriptions
Primary Outcome Measure Information:
Title
Exclusivity
Description
Exclusive breastfeeding
Time Frame
6 weeks postpartum
Secondary Outcome Measure Information:
Title
Any Breastfeeding
Description
Any reported breastfeeding
Time Frame
6 weeks postpartum
Title
Duration
Description
Duration of breastfeeding
Time Frame
6 weeks postpartum
Title
Formula
Description
Rate of formula use
Time Frame
6 weeks postpartum
Title
Compliance
Description
Compliance with postpartum visit
Time Frame
6 weeks postpartum
Title
Mood
Description
Mood assessment using PHQ-2
Time Frame
2 and 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: >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 Exclusion Criteria: Contraindication to breastfeeding Delivery of infant requiring ICN admission Physician discretion that patient will be unable to comply with the protocol
Facility Information:
Facility Name
Hospital of the University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36201773
Citation
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.
Results Reference
derived

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Lactation Achievement With Texts at Home

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