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Completed

NCT Number: NCT04108533

Lactation Achievement With Texts at Home

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text-Based Support

Behavioral

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

Primary outcomes

  1. Exclusivity

    Time frame: 6 weeks postpartum

    Exclusive breastfeeding

Secondary outcomes

  1. Any Breastfeeding

    Time frame: 6 weeks postpartum

    Any reported breastfeeding

  2. Duration

    Time frame: 6 weeks postpartum

    Duration of breastfeeding

  3. Formula

    Time frame: 6 weeks postpartum

    Rate of formula use

  4. Compliance

    Time frame: 6 weeks postpartum

    Compliance with postpartum visit

  5. Mood

    Time frame: 2 and 6 weeks postpartum

    Mood assessment using PHQ-2

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

LATcH: Lactation Achievement With Texts at Home

Acronym: LATcH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2019
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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