Lactation Achievement With Texts at Home

NCT ID: NCT04108533

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2021-03-30

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.

Conditions

Breastfeeding; Breastfeeding, Exclusive; Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Text-Based Support

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.

Group Type: EXPERIMENTAL

Text-Based Support

Intervention Type: BEHAVIORAL

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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text-Based Support

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Celeste Durnwald

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital of the University Of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36201773 (View on PubMed)

Other Identifiers

833824

Identifier Type: -

Identifier Source: org_study_id