Breastfeeding Promotion Programs — September 2018 Version

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This is an interim intervention report. We have spent limited time to form an initial view of this program and, at this point, our views are preliminary. We plan to consider undertaking additional work on this program in the future.

Summary

Published: September 2018

What is the problem?

The World Health Organization (WHO) and UNICEF have issued infant feeding guidelines centered on promoting breastfeeding, but current breastfeeding practices in many countries fail to follow these recommendations. WHO and UNICEF believe that increasing breastfeeding rates is critical to improving health, nutrition, and mortality outcomes.1

WHO and UNICEF recommend that ideal feeding for infants should include:

• Early initiation of breastfeeding within 1 hour of birth
• Exclusive breastfeeding (EBF) from birth until 6 months of age2
• Partial breastfeeding with complementary solid foods from 6 months until 24 months of age or older3

WHO estimates that as of 2017, global breastfeeding rates did not reflect these goals, with early initiation reaching 44% of infants, exclusive breastfeeding during the first 6 month of life reaching 40%, and 24 months of breastfeeding reaching 45%.4

While these recommendations apply to all infants worldwide, the risks of inadequate breastfeeding behaviors are likely to be higher in low-resource environments with poor sanitation and worse substitute foods, so this report focuses primarily on interventions in low- and middle-income countries.5

What is the program?

Breastfeeding support programs may reduce barriers to breastfeeding and allow mothers to breastfeed longer and more intensively. This report focuses on interventions to educate and encourage individual mothers to increase breastfeeding exclusivity and duration, since breastfeeding initiation rates in low-income countries are already generally quite high.6

WHO and UNICEF have spearheaded a complex hospital-based promotion program called the Baby-Friendly Hospital Initiative (BFHI) that supports breastfeeding through maternity and birth delivery care in hospital facilities.7 Many mothers in low-income countries do not give birth in hospitals, so they cannot easily be reached by hospital-based programs.8 Alternative promotion interventions designed to reach these mothers often include various community-based programs featuring education from trained counselors through home visits to women who have recently given birth.

Does the program have strong evidence of effectiveness?

We address evidence regarding two important questions about the impacts of breastfeeding promotion interventions:

1. Does breastfeeding promotion cause uptake of more breastfeeding?
2. What health benefits might result from increasing breastfeeding?

We believe there is reasonably strong evidence from randomized trials that breastfeeding support programs can lead to increases in rates of exclusive breastfeeding up to 6 months and breastfeeding duration, as recommended by WHO/UNICEF. The impact of these programs on exclusive breastfeeding may be larger in low-income countries. There is additional evidence that increasing breastfeeding reduces diarrhea morbidity, which likely leads to reductions in childhood mortality from diarrhea. Breastfeeding may also cause additional benefits that we have not yet vetted.

There is an unusually large volume of evidence available about breastfeeding, its promotion, and its impacts. We are at an early stage in our investigation of this topic, and this report represents our best-guess interpretation of the evidence we have seen up to this point. However, we are aware that a significant amount of research exists that we have not yet considered, and we want to stress that our current conclusions are preliminary.

RCT evidence for breastfeeding promotion interventions

McFadden et al. 2017 is a Cochrane Collaboration meta-analysis of breastfeeding promotion programs. It includes data from 73 randomized controlled trials (RCTs) across 29 countries, spanning low-income to high-income countries.9 It finds statistically significant increases in rates of exclusive breastfeeding up to 6 months and durations of breastfeeding.10 This result incorporates various types of support programs. The following footnote describes program features that may have contributed to success at promoting exclusive breastfeeding.11 The meta-analysis authors noted that results differed widely across studies and consequently downgraded the quality of the evidence to "moderate".12

Only a small percentage of the data used in the Cochrane review (8%) is from low- and lower-middle income countries,13 which are the contexts we are most interested in.14 Given the potential for these results to differ from the meta-analysis average, we reviewed the abstracts of each of the studies from low- and lower-middle income countries included in the meta-analysis and summarized them in the following table. Each of these studies finds statistically significant positive impacts on exclusive breastfeeding (EBF) rates, and the effect sizes are generally larger than the overall meta-analysis effect. It appears that breastfeeding support interventions may have larger-than-average impacts on inducing mothers to breastfeed in low-income countries.

RCTs of breastfeeding promotion in low-income countries

Paper	Country	Result	Source
Haider et al. 2000	Bangladesh	Significant increase in rates of EBF at 5 months (difference=64%; 95% CI 57%-71%).	Source
Tylleskar et al. 2011a	Uganda	Statistically significant increase in rates of EBF at 12 and 24 weeks under both 24-hr and 7-day recall.	Source
Tylleskar et al. 2011b	Burkina Faso	Statistically significant increase in rates of EBF at 12 and 24 weeks under both 24-hr and 7-day recall.	Source
Yotobieng et al. 2015	DR Congo	No difference in early initiation; increased EBF at 14 weeks and 24 weeks from BFHI Steps 1-9.	Source
Bhandari et al. 2003	India	Increased rates of EBF at 3 months (odds ratio 4.02, 95% CI 3.01-5.38, p<0.0001).	Source
Ochola et al. 2013	Kenya	Mothers treated with multiple home counseling sessions were four times as likely to EBF at 6 months (adjusted relative risk = 4.01; 95% CI 2.30, 7.01; P=0.001). No significant difference for mothers treated with one prenatal counseling session.	Source
Sikander et al. 2015	Pakistan	60% reduced risk of stopping EBF during the first 6 months (adjusted hazard ratio, 0.40 [95% CI: 0.27-0.60], P&#60.001).	Source
Bashour et al. 2008	Syria	Significant increases in EBF in unspecified timeframe.	Source
All information in the "Result" column of this table is sourced from the abstract of each respective study.

Evidence for health impacts of breastfeeding

The evidence for the impacts of increasing breastfeeding rates is challenging to evaluate, since much of it is observational and covers benefits that may materialize many years later.15 In brief, breastfeeding is correlated with several health benefits for both infants and mothers. Short-term benefits may include reduced rates of childhood infections in the digestive tract (e.g. diarrhea), lungs (e.g. pneumonia), and ears for breastfed infants, and improved birth spacing for mothers. Long-term benefits may include reduced breast and ovarian cancer rates for breastfeeding mothers, developmental benefits for infants that increase adult earnings potential, and reduced rates of diabetes for both. These health benefits could result in lives saved from infectious diseases for children and fewer cancer deaths for women.16

Researching the strength of the evidence for each one of these benefits is beyond the scope of this preliminary review. Instead, we focus on one key benefit: reductions in diarrhea and diarrhea-related mortality from the program. This benefit has supporting evidence from several RCTs and has the potential to have a large short-term impact in terms of lives saved. Diarrhea is the second-leading cause of mortality in children 1-59 months old globally, with the burden roughly estimated at 9% of all under-5 deaths (over 500,000 annual deaths) as of 2015.17

Evidence for reduction in diarrhea rates

Horta & Victora 2013, a meta-analysis of the evidence for breastfeeding reducing the risk of diarrhea,18 combines evidence from three randomized controlled trials of breastfeeding promotion and finds that rates of diarrhea were about one-third lower in the treatment groups.19 This result is presumably driven by significant increases in breastfeeding rates in the treatment group over the control group in each of these three trials.20

This randomized evidence speaks to diarrhea morbidity but not diarrhea mortality. We expect that, all else equal, reductions in diarrhea morbidity would lead to reductions in diarrhea mortality in places where a substantial diarrhea mortality burden is present. Horta & Victora 2013, which we cite above, also reviewed observational studies on the direct impact of breastfeeding on diarrhea mortality. We have not looked at these results closely but note that they are consistent with the notion that breastfeeding reduces infant mortality attributable to diarrhea.21

Possible mechanisms for a reduction in diarrhea rates

Several mechanisms have been proposed that may link breastfeeding to protection against diarrhea.22 These sound plausible to us, but we have not vetted them.

Are there any potential negative impacts of the program?

This section proposes possible negative impacts of the intervention for further investigation in the future. We have not examined these negative impacts carefully or seen compelling evidence that they would offset potential benefits of the intervention, but we speculate that breastfeeding promotion interventions could pose several problems:

• A risk of accidentally malnourishing a minority of infants if advice to breastfeed exclusively is given and taken too rigidly. Some mothers may struggle to breastfeed or face physical constraints including infection and undersupply.
• A risk of causing mental distress in mothers who feel social pressure to breastfeed but are unable to do so.
• A risk of compounding malnutrition in mothers in low-resource environments.
• A risk that compliance with the breastfeeding guidelines may be an obstacle to maternal employment and financial stability.
• A risk of HIV transmission to infants via breastfeeding in HIV-positive mothers without access to recommended antiretroviral drug regimens.

Is the program cost-effective?

A preliminary cost-effectiveness model for this intervention is available here. Breastfeeding promotion programs may be in the same range of cost-effectiveness as our other priority programs for some ranges of program costs, but this estimate depends on several very uncertain assumptions. In particular, we lack key information about program costs.

Note that our cost-effectiveness analyses are simplified models that do not take into account a number of factors. There are limitations to this kind of cost-effectiveness analysis, and we believe that cost-effectiveness estimates such as these should not be taken literally due to the significant uncertainty around them. We provide these estimates (a) for comparative purposes and (b) because working on them helps us ensure that we are thinking through as many of the relevant issues as possible.

Major uncertainties in our current cost-effectiveness model of breastfeeding promotion include:

• Program costs. We have not located reliable cost data for this type of program, so the current cost input of $15 is hypothetical and reflects a threshold at which the program would be marginally competitive with our other top charities. However, if actual costs per mother/child pair are substantially higher than $15, this program may not be be competitive.
• Which benefits to model. Our current model calculates benefits based only on reductions in morbidity and mortality from diarrhea illness, and it appears that the program may be cost-effective or nearly cost-effective based on these alone. Cost-effectiveness could rise if further research leads us to attribute additional benefits to the program.
• How much reductions in diarrhea morbidity reduce mortality. It seems plausible that reductions in incidence of diarrhea illness would reduce mortality rates from diarrhea-related causes, but this likely depends on the severity of the cases that breastfeeding averts.
• Diminishing returns. There is a risk that it may be increasingly difficult and costly to induce additional mothers to breastfeed after a certain point. We have included a downward adjustment in our cost-effectiveness estimates to account for this possibility, but further investigation into the optimal duration and intensity of promotion programs is needed.
• Multiplier effects. We believe that it is appropriate to include a multiplier effect of breastfeeding programs' impacts to account for the information and skills that mothers learn transferring to future births. This input has a substantial impact on cost-effectiveness, but our current value is largely a guess.23

Does the program have room for more funding?

We are not aware of specific funding gaps for breastfeeding promotion, but we would guess that there is room for more funding given the global scale of the program. Further investigation is needed to determine how much additional funding breastfeeding programs would be able to absorb.

Organizations that implement this program

Numerous organizations work on breastfeeding advocacy, and we have not attempted to identify all of them. We are aware that Alive & Thrive performs technical assistance for breastfeeding promotion in several developing countries. Other organizations may provide breastfeeding information as part of a package of nutrition and health education interventions targeted at new mothers.

Key questions for further investigation

Questions we would ask as part of further investigation include:

• How strong is the evidence for other proposed benefits of breastfeeding (besides reducing diarrhea)?
• How persuasive is the observational evidence connecting breastfeeding to mortality reductions?
• How much might the size of the impact of breastfeeding on diarrhea incidence and prevalence vary across contexts?
• How well do breastfeeding promotion programs scale up from trials to the population level?
• What is the evidence supporting the specific parameters of the WHO/UNICEF feeding guidelines, especially for exclusive breastfeeding to six months exactly?
• How well do self-reported increases in breastfeeding in trials correlate with actual breastfeeding behavior?
• What are the biological mechanisms through which breastfeeding could have positive impacts on health and how strong is the evidence for them?

Sources

Document	Source
WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018	Source (archive)
WHO et al. 2008	Source (archive)
UNICEF 2018	Source (archive)
Haider et al. 2000	Source (archive)
McFadden et al. 2017	Source (archive)
Liu et al. 2016	Source (archive)
Horta & Victora 2013	Source (archive)
Victora et al. 2016	Source (archive)

• 1

  "Breastfeeding is critical for achieving global goals on nutrition, health and survival, economic growth and environmental sustainability. . . .Inadequate breastfeeding practices significantly impair the health, development and survival of infants, children and mothers. Improving these practices could save over 820 000 lives a year." WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018, p. 8.
  

• 2

  Exclusive breastfeeding is defined as requiring the infant to receive breastmilk and only allowing her to receive "ORS [oral rehydration solution], drops, syrups (vitamins, minerals, medicines)" in addition. WHO et al. 2008, p. 4.

• 3

  "WHO and the United Nations Children’s Fund (UNICEF) recommend that breastfeeding be initiated within the first hour after birth, continued exclusively for the first 6 months of life and continued, with safe and adequate complementary foods, up to 2 years or beyond." WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018, p. 8.

• 4

  "Globally, a minority of infants and children meet these recommendations: only 44% of infants initiate breastfeeding within the first hour after birth and 40% of all infants under 6 months of age are exclusively breastfed. At 2 years of age, 45% of children are still breastfeeding." WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018, p. 8.

• 5

  "Several mechanisms for a possible protective effect of breastfeeding against gastrointestinal infections have been proposed, including the presence in breastmilk of substances with antimicrobial or immunological properties, avoidance of contamination (as in non-human milk or baby bottles), and the general nutritional status of breastfed infants...

  …[N]on-breastfed infants are more exposed to pathogens that may cause diarrhea than breastfed subjects. Many studies attest to the presence of pathogens in foods offered to infants. For example, in The Gambia, Rowland et al observed that weaning foods traditionally given to children were contaminated with microorganisms that could cause gastrointestinal infections. Another study from Chile showed that most feeding bottles harbored large numbers of pathogens that could cause gastrointestinal infection.

  Last, it has been proposed that in low-income settings optimal breastfeeding practices can prevent undernutrition associated with repeated infections and with the use of over-diluted breastmilk substitutes. Good nutrition is essential for non-specific immunity that contributes to fighting infections in general." Horta & Victora 2013, p. 12.

• 6

  According to UNICEF data, rates of ever breastfeeding are well above 90% in the majority of low- and middle-income countries. See UNICEF 2018, Excel data download for "Initiation of breastfeeding (birth)", sheet "Ever Breastfed_trends", Column J.

• 7

  "The BFHI focuses on protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services. It is understood that many other interventions are needed to ensure adequate support for breastfeeding, including in antenatal care, postpartum care, communities and workplaces, as well as adequate maternity protection and Code legislation." WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018, p. 7.

• 8
  • "The BFHI has been implemented in almost all countries in the world, with varying degrees of success. After more than a quarter of a century, coverage at a global level remains low. As of 2017, only 10% of infants in the world were born in a facility currently designated as "Baby-friendly". WHO & UNICEF, Revised Baby-Friendly Hospital Initiative 2018, p. 6.
  • For example, other strategies to promote breastfeeding were studied in Bangladesh because "the main strategy for breastfeeding promotion is the WHO/UNICEF baby-friendly hospital initiative, but this initiative fails to reach most mothers in Bangladesh since about 95% have home deliveries." Haider et al. 2000, p. 1643.

• 9

  "This updated review includes 100 trials involving more than 83,246 mother-infant pairs of which 73 studies contribute data (58 individually-randomised trials and 15 cluster-randomised trials). . . .The 73 studies were conducted in 29 countries." McFadden et al. 2017, p. 2.

• 10

  "Results of the analyses continue to confirm that all forms of extra support analyzed together showed a decrease in cessation of ’any breastfeeding’, which includes partial and exclusive breastfeeding (average risk ratio (RR) for stopping any breastfeeding before six months 0.91, 95% confidence interval (CI) 0.88 to 0.95; moderate-quality evidence, 51 studies) and for stopping breastfeeding before four to six weeks (average RR 0.87, 95% CI 0.80 to 0.95; moderate-quality evidence, 33 studies). All forms of extra support together also showed a decrease in cessation of exclusive breastfeeding at six months (average RR 0.88, 95% CI 0.85 to 0.92; moderate-quality evidence, 46 studies) and at four to six weeks (average RR 0.79, 95% CI 0.71 to 0.89; moderate quality, 32 studies)." McFadden et al. 2017, p. 2.

• 11

  "Factors that may have contributed to the success for women who exclusively breastfed were face-to-face contact (rather than contact by telephone), volunteer support, a specific schedule of four to eight contacts and high numbers of women who began breastfeeding in the community or population (background rates)." McFadden et al. 2017, p. 3.

• 12

  "We downgraded evidence to moderate-quality due to very high heterogeneity. . . .The term 'high-quality evidence' means that we are confident that further studies would provide similar findings. No outcome was assessed as being 'high-quality'. The term 'moderate-quality evidence' means that we found wide variations in the findings with some conflicting results in the studies in this review. New studies of different kinds of support for exclusive breastfeeding may change our understanding." McFadden et al. 2017, pp.2-3.

• 13
  • "[F]our studies with 3260 participants (4.4% of the total number of participants) were conducted in low-income countries (Bangladesh, Haider 2000; Burkina Faso and Uganda, Tylleskar 2011a and Tylleskar 2011b; and the Democratic Republic of the Congo, Yotebieng 2015);
  • four studies with 2534 participants (3.4%) were conducted in low-middle income countries (India, Bhandari 2003; Kenya, Ochola 2013; Pakistan, Sikander 2015; and Syria, Bashour 2008)." McFadden et al. 2017, p. 15.

• 14

  We are most interested in results from low-income countries because they have relatively high childhood diarrhea mortality rates, and thus we believe they are likely to get larger benefits from increasing breastfeeding rates, increasing the cost-effectiveness of the intervention. For more information, see the sections on health impacts and cost-effectiveness below.

• 15

  Many benefits are limited to having observational evidence because it is unethical to randomize mother/child pairs into and out of breastfeeding: "On the other hand, the short-term benefits of breastfeeding evaluated in the present meta-analyses are an ethical challenge to the design of randomized trials on the consequences of breastfeeding. It is currently unethical to randomly allocate subjects to receive breastmilk." Horta & Victora 2013, p. 4.

• 16
  • "Our meta-analyses indicate protection against child infections and malocclusion, increases in intelligence, and probable reductions in overweight and diabetes. We did not find associations with allergic disorders such as asthma or with blood pressure or cholesterol, and we noted an increase in tooth decay with longer periods of breastfeeding. For nursing women, breastfeeding gave protection against breast cancer and it improved birth spacing, and it might also protect against ovarian cancer and type 2 diabetes. The scaling up of breastfeeding to a near universal level could prevent 823 000 annual deaths in children younger than 5 years and 20 000 annual deaths from breast cancer. Recent epidemiological and biological findings from during the past decade expand on the known benefits of breastfeeding for women and children, whether they are rich or poor." Victora et al. 2016, abstract.
  • "In terms of child morbidity, overwhelming evidence exists from 66 different analyses, mostly from LMICs and including three randomised controlled trials, that breastfeeding protects against diarrhoea and respiratory infections. About half of all diarrhoea episodes and a third of respiratory infections would be avoided by breastfeeding." Victora et al. 2016, p. 479.
  • "Our reviews suggest important protection against otitis media [ear infections] in children younger than 2 years of age, mostly from high-income settings, but inconclusive findings for older children." Victora et al. 2016, p. 479.

• 17

  "Among children who died in the 1-59-month period, the leading causes were pneumonia (0·762 million [UR 0·651–0·943], 12·8% [UR 11·5–14·6]), diarrhoea (0·509 million [0·401–0·661], 8·6% [7·0–10·2]), and injuries (0·327 million [0·272–0·410], 5·5% [4·6–6·3])." Liu et al. 2016, p. 3030 and Figure 1, p. 3029.

• 18

  We rely on Horta & Victora 2013 for this evidence because, while our impression is that there is a large body of observational evidence on the relationship between breastfeeding and diarrhea, this meta-analysis is the only one we are currently aware of that separately identifies randomized evidence of the impacts on diarrhea specifically. The Horta & Victora 2013 results also reflect the intent-to-treat effect of breastfeeding promotion programs on diarrhea morbidity, so we expect these results to be particularly relevant to the sort of programs we are evaluating in this report.

• 19

  "[W]e identified three randomized trials of breastfeeding promotion; diarrhea morbidity was lower in the group receiving the intervention [pooled relative risk: 0.69 (95% confidence interval: 0.49; 0.96)]." Horta & Victora 2013, p. 2.

• 20

  "In Belarus, the Promotion of Breastfeeding Trial randomly assigned maternity hospitals and their affiliated polyclinics to the Baby-Friendly Hospital Initiative. The proportion of infants exclusively breastfed at 3 and 6 months was substantially higher among infants from the intervention group.... On the other hand, compliance to the intervention was far from universal, only 43.3% of the infants in the intervention group were exclusively breastfed at 3 months compared to 6.4% in the comparison arm. In Mexico, Morrow et al randomly allocated mothers to one of the intervention group (six or three breastfeeding-counseling home visits) or to the control group. The proportion of exclusively breastfed infants at 3 months was higher among those whose mother received six visits. In another trial in India, mothers were assigned to receive or not visit on promotion of exclusive breastfeeding, at 3 months the proportion of exclusively breastfed infants was higher among infants in the intervention group. In these trials, intervention and control groups represented a mixture of breastfeeding practices. Therefore, the effect of breastfeeding is underestimated, and statistical power is reduced." Horta & Victora 2013, p. 4.

• 21Horta & Victora 2013:
  • "With respect to mortality, breastfeeding markedly decreased the risk of diarrhea mortality [pooled relative risk: 0.23 (95% confidence interval: 0.13; 0.42)]. Similarly to the observed for hospitalization, the effect of breastfeeding was higher among infants younger than 6 months. (Figure 5.8)." P. 15.
  • Each of the seven observational component studies in the meta-analysis of diarrhea mortality shows a statistically significant mortality reduction associated with breastfeeding; see Figure 5.8, p. 28.

• 22

  "Several mechanisms for a possible protective effect of breastfeeding against gastrointestinal infections have been proposed, including the presence in breastmilk of substances with antimicrobial or immunological properties, avoidance of contamination (as in non-human milk or baby bottles), and the general nutritional status of breastfed infants.

  Breastmilk contains several antimicrobial and anti-inflammatory factors, hormones, digestive enzymes and growth modulators that protect against infections. Below, we briefly discuss the evidence on the protective effect of some of the components of breastmilk.

  Oligosaccharides are the third largest solid component of human milk. It has been suggested that oligosaccharides homology to cell surface carbohydrates would block the attachment of pathogens to the infant’s mucosa, preventing the development of gastrointestinal infections.

  Breastmilk also confers immunity against gastrointestinal infections by carrying antibodies (secretory IgA) produced by mothers who have been exposed to such pathogens, protecting the infant from developing an infection.

  Lactoferrin, one of the main proteins in human milk can destroy pathogens and reduce inflammatory responses. Furthermore, lactoferrin increases the activity of the immune system because it is a growth factor for lymphocytes.

  A second mechanism is that non-breastfed infants are more exposed to pathogens that may cause diarrhea than breastfed subjects. Many studies attest to the presence of pathogens in foods offered to infants. For example, in The Gambia, Rowland et al observed that weaning foods traditionally given to children were contaminated with microorganisms that could cause gastrointestinal infections. Another study from Chile showed that most feeding bottles harbored large numbers of pathogens that could cause gastrointestinal infection.

  Last, it has been proposed that in low-income settings optimal breastfeeding practices can prevent undernutrition associated with repeated infections and with the use of over-diluted breastmilk substitutes. Good nutrition is essential for non-specific immunity that contributes to fighting infections in general." Horta & Victora 2013, p. 12.

• 23

  See our cost-effectiveness model, sheet "Breastfeeding Promotion," note in cell A11 for more.