LIFT: Telemedicine Breastfeeding Support

Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial

The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation

Study Overview

• Status: Active, not recruiting
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Standard of Care; Behavioral: Telemedicine Support

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadley Sauers-Ford, MPH; Phone Number: 916-734-4729; Email: hsauersford@ucdavis.edu
• Study Contact Backup: Name: Iesha Miller, MA; Email: itmiller@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California-Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• maternal age 18-49 years
• late preterm delivery (34-37 6/7 weeks)
• enrollment up to 1 week postpartum
• breastfeeding initiated
• access to a smartphone, tablet, or laptop computer in their home

Exclusion Criteria:

• incarceration
• inability to communicate in English
• infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Standard of care	Other: Standard of Care; Standard of Care
Experimental: Telemedicine Support; Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine	Behavioral: Telemedicine Support; Telemedicine intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience	Mean score on a modified, 16-item Interactive Telehealth Satisfaction Scale >48 (corresponding to better than neutral on a 5 point Likert scale, 16 questions).	One month post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to cessation	Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours)	Monthly up to 12 months
Exclusive breastfeeding cessation	Time to exclusive breastfeeding cessation (assessed via monthly surveys, defined by initiation of formula, water, juice, other liquids, or solid foods)	Monthly up to 12 months
Breastfeeding at 3 months	Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother)	3 months
Exclusive breastfeeding	Proportion of infants breastfeeding without supplementation with other food or liquids at 3 months (assessed via 24 hour recall from infant's mother)	3 months
Individual satisfaction questions	Mean satisfaction on each Interactive Telehealth Satisfaction Scale question	1 month post enrollment

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Laura Kair, MD, University of California, Davis

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): March 29, 2023
• Study Completion (Estimated): March 29, 2024

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1382496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No