in progress

Final Research Plan

Breastfeeding: Interventions

July 14, 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 interventions to support breastfeeding may result in improved maternal and child health outcomes (KQ1). Additionally, the figure illustrates how interventions to support breastfeeding may have an impact on the initiation, duration, intensity, and exclusivity of breastfeeding (KQ2). Further, the figure depicts whether interventions to support breastfeeding are associated with any harms (KQ3).

* For consideration of variation by population and intervention characteristics, see the “Approach to Assessing Health Equity and Variation in Evidence Across Populations” section.

Note: For all Key Questions and Contextual Questions, “breastfeeding” refers to feeding at the breast or feeding expressed breastmilk. “Breastmilk” refers to human milk. When adequately delineated in source studies, precise language (feeding at the breast or feeding expressed breastmilk) will be used when describing the evidence.

  1. Do interventions to support breastfeeding improve child and maternal health outcomes?
  2. Do interventions to support breastfeeding improve the initiation, duration, intensity, and exclusivity of breastfeeding?
  3. What are the harms of 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 child and maternal health outcomes?
  2. What cultural, structural, and social variables contribute to disparities in rates of breastfeeding and inequities in access to breastfeeding support interventions?
  3. What programs help facilitate access to or utilization of breastfeeding support interventions? What harms are associated with these 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? What harms are associated with these interventions?

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; gender; racial, ethnic, and cultural identity; socioeconomic and insurance 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 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, at or around the time of delivery, postpartum, or a combination), interventionist (e.g., lactation consultant, lactation educator/counselor, or peer supporters), intervention duration, number of intervention sessions, and whether the intervention included any in-person contact with the provider or remote support.

The 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* Adolescents or adults involved with or making decisions about feeding their child.
  • 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 substance-exposed individuals, infants in a neonatal intensive care unit, infants born to HIV-positive individuals).
Interventions Interventions designed to support breastfeeding and the 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.
  • Healthcare system–level interventions and hospital policies.
  • Mass media campaigns.
  • Worksite lactation programs.
  • Usual care, as defined within each study.
  • Wait list control.
  • No attention control.
Active breastfeeding support intervention.
Outcomes KQ 1:
  • Maternal health outcomes 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., guilt or anxiety related to infant feeding, severity of postpartum depression, increased incidence of maternal mastitis or nipple pain, newborn hyperbilirubinemia, newborn dehydration, 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.§ Nonrandomized 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 Studies published in English. Studies published in any language other than English.
Quality rating Fair or good-quality studies. Poor-quality studies.

*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.
§Randomization to a breastfeeding support intervention or comparator; can include, but is not limited to: parallel, cluster, pragmatic, factorial, and stepped wedge trial designs, as appropriate.

A draft Research Plan was posted on the USPSTF website for public comment from March 10, 2022, to April 6, 2022. In response to public comment, the USPSTF clarified that it will accurately describe the gender composition of the studies underlying the included evidence to the extent possible. The USPSTF also changed the wording of Contextual Question 2 to reflect potential cultural, structural, and social factors that may influence rates of breastfeeding and access to breastfeeding support interventions. The USPSTF also made other minor clarifying changes.