BreastfeedingLATcHNCT04108533
Lactation Achievement With Texts at Home
A study testing Text-Based Support in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive, Postpartum Depression
- What is being tested?
- Text-Based Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- Contraindication to breastfeeding
- Delivery of infant requiring ICN admission
- Physician discretion that patient will be unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: LATcH: 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.
Read the 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.
- Being tested
- Text-Based Support
- Medical subject headings
- Breast Feeding, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-Based SupportBehavioural
Text-based breastfeeding support as described in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Text-Based Support | Experimental | 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. Receives: Behavioral: Text-Based Support |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusivity
Exclusive breastfeeding
Measured: 6 weeks postpartum
Secondary outcomes (5)
Any Breastfeeding
Any reported breastfeeding
Measured: 6 weeks postpartum
Duration
Duration of breastfeeding
Measured: 6 weeks postpartum
Formula
Rate of formula use
Measured: 6 weeks postpartum
Compliance
Compliance with postpartum visit
Measured: 6 weeks postpartum
Mood
Mood assessment using PHQ-2
Measured: 2 and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start6 Jan 2020
- Primary completion20 Jan 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celeste Durnwald, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108533
- Sponsor's protocol ID
- 833824
- Acronym
- LATcH
- Status last verified
- Aug 2021
- First submitted
- 25 Sep 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36201773
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LATcH: Lactation Achievement With Texts at Home
- ClinicalTrials.gov ID
- NCT04108533
- Acronym / sponsor ID
- LATcH / 833824
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-Based Support | Experimental | Behavioral: Text-Based SupportText-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 | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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
Key exclusion criteria (3 listed)
- Contraindication to breastfeeding
- Delivery of infant requiring ICN admission
- Physician discretion that patient will be unable to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text-Based SupportText-based breastfeeding support as described in arm/group descriptions | Behavioural | Text-Based Support |
Primary outcome
Exclusivity
Time frame: 6 weeks postpartum
Exclusive breastfeeding
5 secondary outcomes
Any Breastfeeding
Time frame: 6 weeks postpartum
Duration
Time frame: 6 weeks postpartum
Formula
Time frame: 6 weeks postpartum
Compliance
Time frame: 6 weeks postpartum
Mood
Time frame: 2 and 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 36201773Bender 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text-Based Support in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusivity (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.