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Breastfeeding SupportNCT02214849

LATCH: Lactation Advice Thru Texting Can Help

A study testing LATCH Intervention in people with Breastfeeding Support, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding Support
What is being tested?
LATCH Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
1 siteUnited States
Study dates
Aug 2014to Feb 2016
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 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women > 18 years
  • Prenatal intention to breastfeed
  • Prenatal enrollment < 28 weeks gestation
  • Have an unlimited text message cell phone plan
  • Knows how to send a text message
  • 5th grade literacy level

Who cannot join

  • Lack of fluency in either English or Spanish
  • Infant born premature (<37 weeks)
  • > 3 days in NICU
  • Any major maternal-newborn medical problem affecting breastfeeding
  • Birth weight <5lbs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale School of Public Health

    New Haven, Connecticut, 06510

Other trials in United States

About this study

The purpose of this study is to find out if a two-way texting platform to be used as an adjunct tool for breastfeeding peer counselors can improve breastfeeding behaviors among women enrolled in the WIC program in Connecticut. The hypothesis of the study is that providing additional information and support through text messaging starting in pregnancy and continuing after the birth of the child will increase exclusive breastfeeding rates during the first six months of life.

Being tested
LATCH Intervention
Keywords
Breastfeeding, Breastfeeding peer counseling, Exclusive breastfeeding, Formula supplementation, Mobile health, WIC program
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LATCH InterventionBehavioural

Study groups in NCT02214849
Study groupRoleWhat they receive
LATCH InterventionExperimentalWomen enrolled in the WIC program and receiving breastfeeding peer counseling services will receive text messages to support them with their breastfeeding intentions. They will start receiving automated text messages starting in pregnancy and continuing throughout the first 6 months after giving birth. Messaging during pregnancy will emphasize what to expect in the hospital, the onset of lactation, skin-to-skin contact with baby, early and often breastfeeding in post-partum period, milk transfer (suck \& swallow), positioning (with links), common breastfeeding problems and how to seek help. Throughout the study, participants will be able to respond to automated text messages with specific questions that will be received and answered by their WIC program peer counselors. Texting will also have prompts to respond occasionally (at minimum once every two weeks) to ensure that phone is still in service and that the participant in the intervention arm are receiving intervention.
Receives: Behavioral: LATCH Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Exclusive Breastfeeding Rate

    Measured: 2 weeks after birth

  2. Change in Exclusive Breastfeeding Rate

    Measured: 3 months after birth

  3. Change in Exclusive Breastfeeding Rate

    Measured: 6 months after birth

Secondary outcomes (13)

  1. Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor

    Measured: 48 hours after giving birth

  2. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    Measured: 2 weeks after birth

  3. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    Measured: 3 months after birth

  4. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors

    Measured: 6 months after birth

  5. Change in breastfeeding self-efficacy

    Self-efficacy refers to an individuals' confidence in their capability to initiate, maintain, and (if stopped) re-start breastfeeding. It will be measured with the scale proposed by Schwarzer. Self-efficacy scale includes 5 questions, each with 4 response options ranging from "very false" to "very true". Average score will be generated by summing responses to questions 1 through 5 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of self-efficacy.

    Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.

    Measured: 2 weeks after birth

  6. Change in breastfeeding self-efficacy

    Measured: 3 months after birth

  7. Change in breastfeeding self-efficacy

    Measured: 6 months after birth

  8. Change in breastfeeding action planning

    Action planning refers to the "when", "where", and "how" of the behavior or the sequence of events making up breastfeeding behaviors. It will be measured with the scale proposed by Schwarzer. Action planning scale includes 7 questions, each with 4 response options ranging from "very false" to "very true". An average score will be generated by summing responses to questions 1 through 7 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of action planning.

    Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.

    Measured: 2 weeks

  9. Change in breastfeeding action planning

    Measured: 3 months

  10. Change in breastfeeding action planning

    Measured: 6 months

  11. Change in breastfeeding coping planning

    Coping planning refers to the identification of potential barriers to engaging in and maintaining breastfeeding behavior and the extent to which an individual has developed strategies to cope with those barriers. It will be measured with the scale proposed by Schwarzer. Coping planning scale includes 6 questions, each with 4 response options ranging from "very false" to "very true". An average score will be generated by summing responses to questions 1 through 6 and dividing by the total number of questions. Average scores will range from 1 to 4. The higher the score the better the level of coping planning.

    Reference: Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Applied Psychology: An International Review. 2008 2008;57(1):1-29.

    Measured: 2 weeks

  12. Change in breastfeeding coping planning

    Measured: 3 months

  13. Change in breastfeeding coping planning

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02214849
Sponsor's protocol ID
1206010472
Status last verified
Apr 2017
First submitted
1 Aug 2014
Last updated
1 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PubMed 32813276

Questions about this trial

What is this clinical trial studying?

A study testing LATCH Intervention in people with Breastfeeding Support, run by Yale University 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 6 inclusion and 5 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 1 May 2017. 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?

Change in Exclusive Breastfeeding Rate (time frame: 2 weeks after birth). The study lists 3 primary outcomes in all. 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 NCT02214849, 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 1 May 2017.

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