- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214849
LATCH: Lactation Advice Thru Texting Can Help
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06510
- Yale School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Exclusive Breastfeeding Rate
Time Frame: 2 weeks after birth
|
2 weeks after birth
|
Change in Exclusive Breastfeeding Rate
Time Frame: 3 months after birth
|
3 months after birth
|
Change in Exclusive Breastfeeding Rate
Time Frame: 6 months after birth
|
6 months after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chance in the Percent of WIC Participants Reached by Breastfeedng Counselor
Time Frame: 48 hours after giving birth
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48 hours after giving birth
|
|
Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
Time Frame: 2 weeks after birth
|
2 weeks after birth
|
|
Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
Time Frame: 3 months after birth
|
3 months after birth
|
|
Change in Number of Contact Between WIC Participants and Breastfeeding Peer Counselors
Time Frame: 6 months after birth
|
6 months after birth
|
|
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. |
2 weeks after birth
|
Change in breastfeeding self-efficacy
Time Frame: 3 months after birth
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3 months after birth
|
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Change in breastfeeding self-efficacy
Time Frame: 6 months after birth
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6 months after birth
|
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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. |
2 weeks
|
Change in breastfeeding action planning
Time Frame: 3 months
|
3 months
|
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Change in breastfeeding action planning
Time Frame: 6 months
|
6 months
|
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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. |
2 weeks
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Change in breastfeeding coping planning
Time Frame: 3 months
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3 months
|
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Change in breastfeeding coping planning
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafael Pérez-Escamilla, PhD, Yale University
- Study Director: Nurit Harari, MD, Yale University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1206010472
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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