LIFT: Telemedicine Breastfeeding Support

NCT03901833 | Completed

• 1 other identifier: 1382496
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to cessation

  Monthly up to 12 months

• Exclusive breastfeeding cessation

  Monthly up to 12 months

• Breastfeeding at 3 months

  3 months

• Exclusive breastfeeding

  3 months

• Individual satisfaction questions

  1 month post enrollment

Study Arms (2)

Telemedicine Support

EXPERIMENTAL

Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine

Behavioral: Telemedicine Support

Control

PLACEBO COMPARATOR

Standard of care

Other: Standard of Care

Interventions

Telemedicine Support BEHAVIORAL

Telemedicine intervention

Telemedicine Support

Standard of Care OTHER

Standard of Care

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Breast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Laura Kair, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 3, 2019
• Study Start: July 24, 2019
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)