Clinical trial NCT04108533: Lactation Achievement With Texts at Home
Official title: LATcH: Lactation Achievement With Texts at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Breastfeeding, Exclusive
Postpartum Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Exclusivity
timeFrame: 6 weeks postpartum
Secondary outcomes:
measure: Any Breastfeeding
timeFrame: 6 weeks postpartum
measure: Duration
timeFrame: 6 weeks postpartum
measure: Formula
timeFrame: 6 weeks postpartum
measure: Compliance
timeFrame: 6 weeks postpartum
measure: Mood
timeFrame: 2 and 6 weeks postpartum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University Of Pennsylvania
state: Pennsylvania
Study officials:
References:
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.