LIFT: Telemedicine Breastfeeding Support

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Behavioral: Telemedicine Support; Other: Standard of Care

• Registration Number: NCT03901833
• Lead Sponsor: University of California, Davis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-03
• Study Start: 2019-07-24
• Primary Completion: 2023-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine Support	Telemedicine Support	Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine
Control	Standard of Care	Standard of care

Primary Outcome Measures

Name	Time	Method
Experience	One month post-enrollment	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California-Davis; 🇺🇸 Sacramento, California, United States