Breastfeeding
Conditions
Keywords
telehealth, telemedicine, health equity, disparities, breastfeeding
Brief summary
This project will assess the impact of a novel breastfeeding support intervention (telelactation), delivered via video calls on personal devices including mobile phones and tablets. The goal of this intervention is to increase access to International Board Certified Lactation Consultants to improve, and reduce disparities in, breastfeeding rates. By implementing a digital randomized controlled trial that recruits participants through a popular pregnancy tracker mobile phone application, this mixed methods study will recruit a national sample of 1800-2400 individuals (depending on rate of attrition) during their third trimester of pregnancy to 1) provide evidence on the effectiveness of a widely available, yet understudied, service and 2) leverage technology to promote one of the most widely recommended health behaviors to improve children's health and to reduce disparities in key maternal and child health outcomes.
Detailed description
This study is a pragmatic, parallel design randomized controlled trial that will generate evidence on the impact of telelactation on breastfeeding duration and exclusivity and explore differences in effectiveness by race/ethnicity. The study is mixed methods, and uses a sequential explanatory design in which qualitative interviews are used to explain and contextualize findings from the quantitative outcomes analysis. We will recruit primiparous, pregnant individuals age \> 18 who intend to breastfeed and live in states most underserved by IBCLCs. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by one million pregnant individuals in the U.S. annually. Participants will be randomized to: 1) on-demand telelactation video calls on personal devices or 2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for eight months (including six months postpartum), generating 1) quantitative data on the impact of telelactation and differences in effectiveness across racial and ethnic minority groups; and 2) rich qualitative data on the experiences of different subgroups of parents with the intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model.
Interventions
BEHAVIORALTelelactation support
Participants will get unlimited access (through 24 weeks postpartum) to video calls with lactation consultants who are available 24/7. Participants can use the service as demanded.
Sponsors
University of Pittsburgh
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 years of age * pregnant with first child * intend to attempt breastfeeding * residing in a state underserved by IBCLCs
Exclusion criteria
* non-singleton pregnancy * advised by healthcare provider not to breastfeed for a medical reason (e.g., HIV+ status, chemotherapy planned) * in police custody or incarcerated * infant to be separated from birthing parent (e.g., given up for adoption, military deployment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Duration 1 | 6 months postpartum | Number of participants who report any breastfeeding at 6 months |
| Breastfeeding Duration 2 | 6 months post-partum | Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk) |
| Breastfeeding Exclusivity | 6 months postpartum | Number of participants who report no formula use at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Satisfaction | 6 months postpartum | Breastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telelactation Support Participants in the experimental group received unlimited, free telelactation visits with lactation consultants (IBCLCs) as demanded up to 24 weeks post-partum. Services were available through mobile phone app. | 1,052 |
| Ebook Participants in the control arm received care as usual. They also received an ebook with content on infant care. | 1,056 |
| Total | 2,108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 97 | 100 |
Baseline characteristics
| Characteristic | Ebook | Telelactation Support | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1056 Participants | 1052 Participants | 2108 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 380 Participants | 383 Participants | 763 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 676 Participants | 669 Participants | 1345 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Health insurance Commercial or Other | 744 Participants | 729 Participants | 1473 Participants |
| Health insurance Medicaid or Uninsured | 312 Participants | 323 Participants | 635 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 23 Participants | 35 Participants | 58 Participants |
| Race (NIH/OMB) Asian | 48 Participants | 49 Participants | 97 Participants |
| Race (NIH/OMB) Black or African American | 310 Participants | 301 Participants | 611 Participants |
| Race (NIH/OMB) More than one race | 195 Participants | 149 Participants | 344 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 9 Participants | 15 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 474 Participants | 509 Participants | 983 Participants |
| Sex: Female, Male Female | 1056 Participants | 1052 Participants | 2108 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,052 | 0 / 1,056 |
| other Total, other adverse events | 0 / 1,052 | 0 / 1,056 |
| serious Total, serious adverse events | 0 / 1,052 | 0 / 1,056 |
Outcome results
Primary
Breastfeeding Duration 1
Number of participants who report any breastfeeding at 6 months
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telelactation Support | Breastfeeding Duration 1 | 674 Participants |
| Ebook | Breastfeeding Duration 1 | 639 Participants |
p-value: 0.08Regression, Logistic
Primary
Breastfeeding Duration 2
Time to cessation of breastfeeding in months (as measured by reported age of infant when completely stopped receiving breastmilk)
Time frame: 6 months post-partum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telelactation Support | Breastfeeding Duration 2 | 4.4 months | Standard Deviation 2 |
| Ebook | Breastfeeding Duration 2 | 4.5 months | Standard Deviation 2 |
p-value: 0.21discrete-time survival model
Primary
Breastfeeding Exclusivity
Number of participants who report no formula use at 6 months
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telelactation Support | Breastfeeding Exclusivity | 448 Participants |
| Ebook | Breastfeeding Exclusivity | 422 Participants |
p-value: 0.28Regression, Logistic
Secondary
Breastfeeding Satisfaction
Breastfeeding satisfaction at 6 months postpartum. Score on five-item maternal/infant breastfeeding satisfaction scale (which is a subscale of the Hill and Humenick lactation scale). Higher values indicate more agreement with the measures of satisfaction, resulting in a composite satisfaction score ranging from 5 to 25 for the subscale.
Time frame: 6 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telelactation Support | Breastfeeding Satisfaction | 19.49 score on a scale | Standard Deviation 5.43 |
| Ebook | Breastfeeding Satisfaction | 18.95 score on a scale | Standard Deviation 5.6 |
p-value: 0.05Regression, Linear