in progress

Draft Research Plan

Breastfeeding: Interventions

March 10, 2022

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how individual-level interventions to support breastfeeding may result in improved health outcomes in the child and lactating person (KQ1). Additionally, the figure illustrates how individual-level interventions to support breastfeeding may have an impact on the initiation, duration, intensity, and exclusivity of breastfeeding (KQ2). Further, the figure depicts whether individual-level interventions to support breastfeeding are associated with any harms (KQ3).

* For consideration of variation by population and intervention characteristics, see the “Proposed Approach to Assessing Health Equity and Heterogeneity” section.

Note: For all Key Questions and Contextual Questions, “breastfeeding” refers to feeding at the breast/chest or feeding expressed breastmilk. “Breastmilk” refers to human milk.

  1. Do individual-level interventions to support breastfeeding improve health outcomes for the child or lactating person?
  2. Do individual-level interventions to support breastfeeding improve the initiation, duration, intensity, and exclusivity of breastfeeding?
  3. What are the harms of individual-level interventions to support breastfeeding?

Contextual Questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What are the associations between breastfeeding or consuming breastmilk and short- and long-term health outcomes for the child and lactating person?
  2. Are there disparities in rates of breastfeeding initiation and continuation among certain racial, ethnic, and cultural groups? If so, what factors, such as access to interventions to support breastfeeding, are associated with these disparities?
  3. What programs help facilitate access to or utilization of breastfeeding support interventions?
  4. Do healthcare system–level interventions and hospital policies, such as full or partial implementation of the Baby-Friendly Hospital Initiative, improve rates of breastfeeding and health outcomes?

To the extent possible, we plan to describe the participant characteristics and major intervention components of the included studies. Data on population characteristics will help us explore the degree to which the findings are broadly representative of the U.S. population, including individuals across age; sex; racial, ethnic, and cultural identity; socioeconomic status; and geographic region. Evidence will be evaluated to determine if there are common components of efficacious intervention programs and, to the extent possible, whether interventions tailored to specific groups tend to have larger effect sizes than those that are not tailored. As part of our effort to address health equity, we will search for and highlight interventions that demonstrate effectiveness in groups of individuals who historically have lower rates of breastfeeding and in traditionally stigmatized or underrepresented groups. Additionally, the proposed Contextual Questions are designed to address other important health equity considerations. Descriptions of key intervention components will include, for example: intervention type (education, professional support, or peer support), intervention timing (prenatal, peripartum, postpartum, or a combination), intervention duration, number of intervention sessions, and whether the intervention included any in-person contact with the provider or remote support.

The Proposed Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the Key Questions.

Category Included Excluded
Population* Lactating adolescents or adults or persons providing breastmilk and their infants, as well as members of parent-child support system
  • Parents of preterm or very preterm infants (<34 weeks of gestation or low or very low birth weight [<2,500 g]), because of their special feeding needs
  • Studies limited to special populations of individuals or infants (e.g., persons in institutions, infants with prenatal disease, infants born to drug-using individuals, infants in a neonatal intensive care unit, infants born to HIV-positive individuals)
Interventions Interventions designed to increase initiation, exclusivity, or duration of consumption of breastmilk, including individual or group counseling, peer counseling, home visits, structured education, technology- or computer-based support, distribution of written materials, and support provided prenatally, at time of delivery or postpartum
  • Health system–level programs and policies
  • Mass media campaigns
  • Worksite lactation programs
  • Community interventions not affiliated with primary care
  • Usual care, as defined within each study
  • Wait list control
  • No attention control
Active breastfeeding support interventions
Outcomes KQ 1:
  • Health outcomes in the lactating person such as rates of breast and ovarian cancer, diabetes mellitus, weight status, or mental health symptoms
  • Infant and child health outcomes such as gastrointestinal symptoms, atopic dermatitis, respiratory symptoms, otitis media, asthma, or obesity

KQ 2: Breastfeeding initiation, duration, intensity, or exclusivity, as defined within each study

KQ 3: Harms associated with breastfeeding intervention (e.g., feeling criticized by interventionist, guilt related to not breastfeeding, increased anxiety about breastfeeding, postpartum depression, or infant failure to thrive)
Setting Any setting linked with the healthcare system and provision of primary care (e.g., hospital, maternity services, home, or clinic)
  • Correctional facilities
  • Worksites
  • Inpatient/residential facilities
Study design Randomized, controlled trials Non-randomized studies of interventions
Study geography Studies that primarily take place in countries categorized as “Very High” on the 2019 Human Development Index (as defined by the United Nations Development Programme) Studies that primarily take place in countries not categorized as “Very High” on the 2019 Human Development Index
Language English Any language other than English
Quality rating Fair or good-quality studies Poor-quality studies

*We acknowledge that studies on breastfeeding vary in precision when describing the gender identity and sex of study populations. In the absence of specific and detailed information on gender and sex, we will use gender neutral language (e.g., persons, parent) or gender terminology (e.g., woman, man) rather than terminology commonly used to describe biological sex at birth (e.g., female, male). We recognize that the binary construction of gender fails to account for individuals who do not identify as men or women. We will aim to accurately describe the gender composition of the studies underlying the included evidence to the extent possible. 
Proportion of feedings that are breastmilk.