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LATCH: Lactation Advice Thru Texting Can Help

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ClinicalTrials.gov Identifier: NCT02214849
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breastfeeding Support Behavioral: LATCH Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: LATCH: Lactation Advice Thru Texting Can Help
Actual Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: LATCH Intervention
Women 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.
Behavioral: LATCH Intervention



Primary Outcome Measures :
  1. Change in Exclusive Breastfeeding Rate [ Time Frame: 2 weeks after birth ]
  2. Change in Exclusive Breastfeeding Rate [ Time Frame: 3 months after birth ]
  3. Change in Exclusive Breastfeeding Rate [ Time Frame: 6 months after birth ]

Secondary Outcome Measures :
  1. Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor [ Time Frame: 48 hours after giving birth ]
  2. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors [ Time Frame: 2 weeks after birth ]
  3. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors [ Time Frame: 3 months after birth ]
  4. Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors [ Time Frame: 6 months after birth ]
  5. Change in breastfeeding self-efficacy [ Time Frame: 2 weeks after birth ]

    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.


  6. Change in breastfeeding self-efficacy [ Time Frame: 3 months after birth ]
  7. Change in breastfeeding self-efficacy [ Time Frame: 6 months after birth ]
  8. Change in breastfeeding action planning [ Time Frame: 2 weeks ]

    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.


  9. Change in breastfeeding action planning [ Time Frame: 3 months ]
  10. Change in breastfeeding action planning [ Time Frame: 6 months ]
  11. Change in breastfeeding coping planning [ Time Frame: 2 weeks ]

    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.


  12. Change in breastfeeding coping planning [ Time Frame: 3 months ]
  13. Change in breastfeeding coping planning [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214849


Locations
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United States, Connecticut
Yale School of Public Health
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Rafael Perez-Escamilla, PhD Yale University
Study Director: Nurit Harari, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02214849    
Other Study ID Numbers: 1206010472
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Keywords provided by Yale University:
Breastfeeding
Breastfeeding peer counseling
Exclusive breastfeeding
Formula supplementation
Mobile health
WIC program