LATCH: Lactation Advice Thru Texting Can Help

Breastfeeding Support Clinical Trial

Official title:

LATCH: Lactation Advice Thru Texting Can Help

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214849
• Other study ID #: 1206010472
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: April 28, 2017
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding Support

Intervention

Behavioral:
• LATCH Intervention

Locations

Country	Name	City	State
United States	Yale School of Public Health	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Exclusive Breastfeeding Rate		2 weeks after birth
Primary	Change in Exclusive Breastfeeding Rate		3 months after birth
Primary	Change in Exclusive Breastfeeding Rate		6 months after birth
Secondary	Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor		48 hours after giving birth
Secondary	Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors		2 weeks after birth
Secondary	Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors		3 months after birth
Secondary	Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors		6 months after birth
Secondary	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.	2 weeks after birth
Secondary	Change in breastfeeding self-efficacy		3 months after birth
Secondary	Change in breastfeeding self-efficacy		6 months after birth
Secondary	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.	2 weeks
Secondary	Change in breastfeeding action planning		3 months
Secondary	Change in breastfeeding action planning		6 months
Secondary	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.	2 weeks
Secondary	Change in breastfeeding coping planning		3 months
Secondary	Change in breastfeeding coping planning		6 months