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OpenTrials
Completed

NCT Number: NCT03901833

LIFT: Telemedicine Breastfeeding Support

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Telemedicine Support

Behavioral

Telemedicine intervention

Standard of care

Other

Standard of Care

Primary outcomes

  1. Experience

    Time frame: 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 outcomes

  1. Time to cessation

    Time frame: 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)

  2. Exclusive breastfeeding cessation

    Time frame: 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)

  3. Breastfeeding at 3 months

    Time frame: 3 months

    Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother)

  4. Exclusive breastfeeding

    Time frame: 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)

  5. Individual satisfaction questions

    Time frame: 1 month post enrollment

    Mean satisfaction on each Interactive Telehealth Satisfaction Scale question

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 3, 2019
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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