Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 12:48 PM
Study NCT ID:
NCT04108533
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2019-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactation Achievement With Texts at Home
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
LATcH: Lactation Achievement With Texts at Home
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LATcH
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: