Expanding Rural Access to Breastfeeding Support Via Telehealth: The Tele-MILC Trial
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|ClinicalTrials.gov Identifier: NCT02870413|
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding||Behavioral: Telelactation services||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Acceptability, Feasibility, and Impact of Telelactation Among Rural Mothers|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
Experimental: Telelactation support
Participants in the experimental group will receive unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 12 weeks post-partum. Services will be available through mobile phone app.
Behavioral: Telelactation services
Mothers will get unlimited access (for a three month period) to video calls with lactation consultants who are available 24/7. Mothers can use the service as demanded.
Other Name: Virtual/remote breastfeeding support
No Intervention: Usual care
Participants in the control arm will receive care as usual.
- Any breastfeeding (yes/no) at 3 months [ Time Frame: Three months ]
- Exclusive breastfeeding (yes/no) at 3 months [ Time Frame: Three months ]
- Breastfeeding satisfaction (self-reported via questionnaire at 3 months postpartum) [ Time Frame: Three months ]Survey question which captures extent of satisfaction with the experience of breastfeeding. Question reads: How satisfied do you feel about the experience of breastfeeding your baby over the past three months? (Very unsatisfied, somewhat unsatisfied, neither unsatisfied nor satisfied, somewhat satisfied, very satisfied). We will create a binary variable (satisfied vs. unsatisfied) based on this response, with those reporting "somewhat satisfied" or "very satisfied" defined as "satisfied."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870413
|United States, Virginia|
|Arlington, Virginia, United States, 22202|