BreastfeedingNCT03901833
LIFT: Telemedicine Breastfeeding Support
A study testing Telemedicine Support in people with Breastfeeding, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Telemedicine Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- incarceration
- inability to communicate in English
- infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: 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
- Conditions
- Breastfeeding
- Being tested
- Telemedicine Support, Standard of Care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine SupportBehavioural
Telemedicine intervention
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Support | Experimental | Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine Receives: Behavioral: Telemedicine Support |
| Control | Placebo comparator | Standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One month post-enrollment
Secondary outcomes (5)
Time to cessation
Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 months
Individual satisfaction questions
Mean satisfaction on each Interactive Telehealth Satisfaction Scale question
Measured: 1 month post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start24 Jul 2019
- Primary completion29 Mar 2023
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Laura Kair, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901833
- Sponsor's protocol ID
- 1382496
- Status last verified
- Nov 2024
- First submitted
- 27 Mar 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03901833
- Acronym / sponsor ID
- 1382496
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Support | Experimental | Behavioral: Telemedicine SupportWeekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine |
| Control | Placebo comparator | Other: Standard of CareStandard of care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- incarceration
- inability to communicate in English
- infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine SupportTelemedicine intervention | Behavioural | Telemedicine Support |
| Standard of CareStandard of Care | Other | Control |
Primary outcome
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).
5 secondary outcomes
Time to cessation
Time frame: Monthly up to 12 months
Exclusive breastfeeding cessation
Time frame: Monthly up to 12 months
Breastfeeding at 3 months
Time frame: 3 months
Exclusive breastfeeding
Time frame: 3 months
Individual satisfaction questions
Time frame: 1 month post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Kair, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Support in people with Breastfeeding, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience (time frame: One month post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.