Ross Products Division, Abbott Laboratories, Columbus, Ohio
| ABSTRACT |
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METHODS. The Ross Laboratories Mothers Survey is a national survey designed to determine patterns of milk feeding during infancy. Mothers were asked to recall the type of milk fed to their infant in the hospital and during each month of age. Rates of breastfeeding in the hospital and at 6 months of age were evaluated. Logistic regression analyses identified significant predictors of breastfeeding in 2003.
RESULTS. From 1978 through 2003, rates for the initiation of breastfeeding among WIC participants lagged behind those of non-WIC mothers by an average of 23.6 ± 4.4 percentage points. At 6 months of age, the gap between WIC participants and non-WIC mothers (mean: 16.3 ± 3.1 percentage points) steadily increased from 1978 through 2003 and exceeded 20% by 1999. Demographic factors that were significant and positive predictors of breastfeeding initiation in 2003 included some college education, living in the western region of the United States, not participating in the WIC program, having an infant of normal birth weight, primipary, and not working outside the home. For mothers of infants 6 months of age, WIC status was the strongest determinant of breastfeeding: mothers who were not enrolled in the WIC program were more than twice as likely to breastfeed at 6 months of age than mothers who participated in the WIC program.
CONCLUSIONS. Breastfeeding rates among WIC participants have lagged behind those of non-WIC mothers for the last 25 years. The Healthy People 2010 goals for breastfeeding will not be reached without intervention. Food package and programmatic changes are needed to make the incentives for breastfeeding greater for WIC participants.
Key Words: breastfeeding WIC trends in breastfeeding demographic characteristics
Abbreviations: WICSpecial Supplemental Nutrition Program for Women, Infants, and Children RMSRoss Laboratories Mothers Survey ORodds ratio IOMInstitute of Medicine
Breastfeeding promotion and support are essential components of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).1 On average, 1.95 million infants per month, or about half of all infants in the United States, participate in WIC.24 A federal program created in 1972, WIC serves pregnant and lactating women, infants, and children up to the age of 5.1 It provides nutrition education, supplemental foods, and referrals for health and social services to women and children who are income eligible and nutritionally at risk. To be income eligible, the applicant's income must fall at or below 185% of the US poverty income guidelines (in 2005, $34873 for a family of 4).1 In addition, an individual who participates or has family members who participate in other benefit programs, such as the Food Stamp Program, Medicaid, or Temporary Assistance for Needy Families, automatically meets the income eligibility requirement, even if household income exceeds 185% of the US poverty income guidelines.1 Two types of nutritional risk are recognized for WIC eligibility: (1) "medically-based risks such as anemia, underweight, overweight, history of pregnancy complications, or poor pregnancy outcomes, and (2) dietary risks, such as failure to meet the dietary guidelines or inappropriate nutrition practices."1
The cost of the WIC program has increased substantially since its inception. In 1974, Congress appropriated $20.6 million when 25% of the infants in the United States were enrolled.1 By comparison, for the fiscal year 2005, when 48% of US infants were enrolled, the WIC program appropriation was $5.235 billion.1 An additional $1.52 billion was provided to WIC in the form of cash rebates from infant formula manufacturers.
Since 1975, specific incentives have been instituted to promote breastfeeding in WIC. In 1992, federal legislation established a national breastfeeding promotion program in WIC to encourage breastfeeding as the best method of infant feeding, foster wider acceptance of breastfeeding, and assist in the distribution of breastfeeding materials.1 WIC mothers who decide to breastfeed are provided information through counseling and breastfeeding educational materials, receive follow-up support through peer counselors, are eligible to participate in WIC longer than nonbreastfeeding mothers, and may receive breast pumps and other materials to support breastfeeding initiation and continuation. However, even in 2005, only $34 million (or 0.6% of the total WIC budget excluding rebates) was set aside for specific incentives designed to increase breastfeeding among WIC participants.4 The questions are, given that breastfeeding promotion and support are important (but not well-funded) tenets of WIC and that today nearly half of US infants are enrolled in WIC (and infant enrollment is growing), what has been the impact of the WIC program on US breastfeeding rates and how do breastfeeding rates of WIC participants compare with those of nonparticipants?
The Department of Health and Human Services Healthy People 2010 breastfeeding goals are: 75% in the early postpartum period and 50% at 6 months of age.5 The main instrument used to monitor progress in meeting these goals is the Ross Laboratories Mothers Survey (RMS).6 The RMS is the longest-running and largest national survey of breastfeeding trends.710 The survey has documented infant feeding trends among WIC participants since 1978, when the WIC program was firmly established in the United States, making the RMS an appropriate instrument to use when considering breastfeeding rates in WIC.
The present study compares rates of breastfeeding among WIC participants and non-WIC mothers from 1978 to 2003. In addition, given that from 2002 to 2003 there was a slight decrease in the initiation of breastfeeding and continuation of breastfeeding to 6 months of age, breastfeeding rates for these 2 consecutive years were evaluated according to several demographic characteristics known to impact breastfeeding. The demographic characteristics considered were participation in the WIC program, maternal parity, ethnic background, age, education, region of residence, birth weight, and maternal postpartum employment. We also identified maternal demographic characteristics that were most important in predicting the decision to initiate and continue breastfeeding to 6 months of age in 2003. This study provides important information that may help define appropriate strategies to address the persistently lower breastfeeding rates among WIC participants.
| METHODS |
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40000 to 50000 questionnaires were mailed each quarter. Beginning in 1991, the survey was conducted monthly. Approximately 60000 questionnaires were mailed each month to mothers at the time their infant was 6 or 12 months of age. In 1997, the sample size was greatly expanded:
1.2 to 1.4 million questionnaires were mailed, 100000 to 117000 each month. Mothers could not participate in the survey for a second time for
4 months to limit the likelihood of nonresponse. Also, beginning in 1997, to eliminate potential problems with recall over a 6-month period, questionnaires were mailed to mothers with infants 1 month of age, 2 months of age, 3 months of age, and so forth, until 12 months of age. Because of the sensitive nature of asking mothers their total family income, the question was eliminated.
Questionnaires were mailed to a probability sample of new mothers selected from a database of names supplied by Experian (Costa Mesa, CA). The database covers >1300000 expectant mothers and >3000000 families with newborns from the US population of
4000000 births. The database is designed to include mothers from all demographic subgroups.
In 2002, 1379700 questionnaires were mailed, and 288000 were returned (response rate: 20.9%). In 2003, 1212200 questionnaires were mailed, and 228000 were returned (response rate: 18.8%). The number of questionnaires that are mailed each year varies by 10% to 15%, depending on internal resources. To ensure that all geographical areas and demographic subgroups were represented, and to adjust for different response rates, regions of the country where the response rates were low were oversampled.
Because the survey is tracking infant feeding on a monthly basis, the responses received in a given year may include some infants that were born in the previous year. For example, a 6-month-old infant whose mother received a questionnaire in March 2003 was born in October 2002. Despite the overlap of breastfeeding data from successive years, rates for breastfeeding in the RMS have been used effectively to monitor yearly and long-term trends. The RMS breastfeeding rates have been compared with those from other national surveys, including the National Surveys of Family Growth,11 the 1988 National Maternal and Infant Health Survey,12 and the third National Health and Nutrition Examination Survey.13 Results of all these comparisons, with data from as early as 1955, demonstrate that despite differences in survey methodology and design, these surveys report similar trends and rates of breastfeeding across demographic characteristics. The advantage of the RMS is its ability to provide breastfeeding rates on a continuous basis over a long period of time. The RMS will be the main instrument used to monitor progress toward meeting the Healthy People 2010 goals.6
From a list of milk feedings, breast milk, all commercial infant formulas, and cow's milk (whole, 2%, etc), mothers were asked the following question: "Please check the milk(s) your youngest infant was fed at the following time periods (CHECK ALL THAT APPLY)." Mothers indicated the type of milk fed to their infant "in the hospital," "at 1 week of age," "in the last 30 days," and "most often in the last week." The question used to determine milk feeding has not been changed since the inception of the survey. However, the list of infant formulas is updated as new products are introduced or other products are removed from the marketplace. The "in the hospital" category was used to determine infant feeding initiated at birth. The "most often in the last week" category was used to determine type(s) of milk fed to a 6-month-old infant. The breastfeeding category included all infants fed human milk exclusively or a combination of human milk and formula or cow's milk (ie, any breastfeeding). This category was used in our previous publications and is used by the US government to monitor breastfeeding trends. Data for exclusive breastfeeding for 2002 and 2003 were available. Exclusive breastfeeding included the subset of infants who were fed only human milk in the hospital and at 6 months of age; no supplemental formula and/or cow's milk were used. Information about the introduction of solid foods fed to infants was not collected.
Each mother was asked to answer questions describing her demographic status and the birth weight of her infant (<2500 g, reference). To evaluate WIC participation status, mothers were asked the following 2 questions: (1) "Since the birth of your youngest infant, have you or your youngest infant participated in the government Supplemental Nutrition Program for Women, Infants, and Children (WIC)?" and (2) "Is your infant currently participating in the WIC Program?" If the respondent provided an affirmative answer to 1 or both of these questions, the respondent was considered to be a WIC participant. The employment variable represented postpartum employment outside the home at the time mothers received the questionnaire. To determine Hispanic origin, mothers were asked, "Are you of Latino/Hispanic origin or descent?"
Statistical Analyses
The responses to the survey were weighted to account for the varying coverage and response rates and to reflect the demographic profile of births in the United States. The weights were based on proportions of mothers within specific demographic subgroups in the United States: maternal region of residence (within 9 census regions), racial background (black, Hispanic, white), maternal age (<25, 2529, >29 years of age), and education (college, no college). The weights that were used corresponded to the demographic variables that have been historically associated with breastfeeding. The weights for these variables were derived from the 2001 US natality data from the National Center for Health Statistics.14 Table 1 shows that the 2003 RMS weighted data were comparable with those published by the National Center for Health Statistics. The 2002 RMS weighted data also were comparable (not presented here but available from the authors). The weighted sample sizes for breastfeeding mothers are presented in Tables 2 and 3.
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A z test was used to determine significant differences in rates of breastfeeding between WIC participants and non-WIC mothers in each year and in each demographic subgroup. In each demographic subgroup of WIC participants and non-WIC mothers, significant differences in rates of breastfeeding between 2002 and 2003 were also determined. An absolute value of z > 1.96 for a 2-tailed test (P < .05) was considered to be unlikely to have occurred by chance.15
Using a stepwise multiple logistic regression analysis,16 we identified significant predictors of breastfeeding in the hospital and at 6 months of age. Odds ratios (ORs) were calculated for 2002 and 2003. Because the ORs were similar, the results from 2003 are presented. Breastfeeding (yes, no) was the dependent variable; the independent variables included maternal age (<30 years,
30 years), maternal education (college, noncollege), WIC participation (not participating in WIC, WIC), parity (primiparous, multiparous), maternal employment (unemployed, employed), race (white, black, Hispanic), Hispanic origin (Hispanic, not Hispanic), and birth weight (normal, <2500 g). The 9 census regions of the United States were combined into 4 larger regions: New England (New England); North (Middle Atlantic, East North Central, West North Central); South (South Atlantic, East South Central, West South Central); and West (Mountain, Pacific). These regions were chosen because: (1) the census regions within each larger geographical region had similar breastfeeding rates, and (2) the combined region provided larger sample sizes for data analyses.
Using a backward elimination procedure, all of the significant variables were initially forced into the equation, but those that were not independently associated with the outcome variables were selectively removed, starting with the least-predictor variable until only the significant predictors were left. Various interaction effects were examined, and no 2-way interactions were detected. Logistic regression coefficients were calculated by using maximum likelihood estimation. The weight variable was included in the procedure. Adjusted ORs and 95% confidence intervals were calculated. The level of significance in all cases was P < .05.
| RESULTS |
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From 1978 to 2003, the disparities between WIC participants and non-WIC mothers for breastfeeding rates at 6 months of age steadily increased and exceeded 20% beginning in 1999 (Fig 2). Rates of breastfeeding at 6 months of age differed between WIC participants and non-WIC mothers by an average of 16.3 ± 3.1% (range: 10.322.4%). At each year, from 1978 to 2003, more than twice as many non-WIC mothers than WIC participants breastfed their 6-month-old infants.
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Prevalence of Breastfeeding by WIC Participation and Demographic Characteristics, 2002 vs 2003
The rates of in-hospital breastfeeding for WIC participants and non-WIC mothers were significantly (P < .05) different across each demographic subgroup in 2002 and 2003 (Table 2). For most demographic characteristics, the differences between WIC and non-WIC in-hospital breastfeeding rates were larger in 2003 than in 2002. For both years, the largest differences between WIC and non-WIC in-hospital breastfeeding rates were among women who were black, older in age, grade-school educated, working part time or not employed, and residing in the East South Central portion of the United States. WIC participants who lived in the East South Central region of the country had the lowest in-hospital breastfeeding rate of any category of WIC participants or non-WIC mothers.
Within each group of WIC participants and non-WIC mothers, differences in the initiation of breastfeeding between 2002 and 2003 across demographic characteristics were statistically significant (P < .05) and larger among WIC participants than non-WIC mothers. Among WIC participants, the largest decreases in the initiation of breastfeeding occurred among women who had a low birth weight infant and among women who were black, Hispanic, or Asian; younger in age (<20 years old); grade-school educated; primiparous; and living in the Middle Atlantic and Pacific regions of the country. Among non-WIC mothers, the largest decreases in the initiation of breastfeeding were found among women who were Hispanic, younger in age (<20 years old), high-school educated, primiparous, living in the Middle Atlantic region of the country, and among those who had a low birth weight infant.
The rates for the initiation of exclusive breastfeeding among WIC participants declined from 33.4% in 2002 to 31.5% in 2003. Among non-WIC mothers, rates of exclusive breastfeeding were 56.3% in 2002 and 54.7% in 2003.
In 2002 and 2003, for both WIC participants and non-WIC mothers, in-hospital breastfeeding was most common in the Western states and among women who were Asian, Hispanic, or white, had a normal birth weight infant, older in age, college educated, and primiparous. Initiation of breastfeeding was also more common among women who were employed part time or not working outside their home than among women who were employed full time.
The demographic factors that were significant and positive predictors of breastfeeding initiation included at least some college education, living in the Western regions of the United States, not participating in the WIC program, having an infant of normal birth weight, primipary, and not working outside the home (Table 4). Some of the ORs for the initiation of breastfeeding were large. The odds for breastfeeding in the hospital were more than 2 times higher for college-educated mothers than for those with less than a college education, and the odds for those living in the West were almost 2 times higher than for mothers living in the South or North. WIC participation status was also strongly associated with the likelihood of whether breastfeeding was initiated. The odds for breastfeeding initiation was 1.82 times greater for mothers who were not enrolled in the WIC program than for mothers who were WIC participants.
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For WIC participants, differences between 2002 and 2003 in rates of breastfeeding at 6 months of age were statistically significant (P < .05) among Hispanic mothers and those who had a high-school education, were employed part time, multiparous, and had a low birth weight infant. However, most differences were small and inconsistent. For WIC participants, small increases in rates of breastfeeding at 6 months of age from 2002 to 2003 were observed among women who were black or Asian, in the 20- to 24- and 30- to 34-year-old age groups, college educated, and residing in the East North Central portion of the United States.
For non-WIC mothers, differences between 2002 and 2003 in rates of breastfeeding at 6 months of age were not statistically significant. From 2002 to 2003, the largest decreases in the rates of breastfeeding at 6 months of age were observed among women who were Hispanic or Asian, in the 20- to 24-year-old age group, grade-school educated, employed full time, and living in the Middle Atlantic region of the country. In many demographic subgroups of non-WIC mothers, there were increases in breastfeeding rates at 6 months of age from 2002 to 2003. In 2002 and 2003, at 6 months of age, approximately twice as many non-WIC mothers than WIC participants were exclusively breastfeeding (22.7% vs 11.1% in 2002, 24.4% vs 10.3% in 2003, respectively).
In 2002 and 2003, for both WIC participants and non-WIC mothers, breastfeeding at 6 months of age was most common in the Mountain and Pacific regions of the country and among women who were Asian, Hispanic, or white; had a normal birth weight infant; older in age; college educated; and multiparous. Breastfeeding at 6 months of age was also more common among women who were employed part time or not working outside their home than among women who were employed full time. Employment status (full-time or part-time) had a larger effect on breastfeeding at 6 months of age than on the initiation of breastfeeding.
WIC status was the strongest determinant of continued breastfeeding to 6 months of age (Table 4). Mothers who were not enrolled in the WIC program were more than twice as likely to continue breastfeeding to 6 months of age than mothers who participated in the WIC program. A college education, not working outside the home, residing in the Western portion of the country, and normal birth weight were also strong, significant predictors of breastfeeding at 6 months of age.
| DISCUSSION |
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For the initiation of breastfeeding, the largest disparity between WIC participants and non-WIC mothers occurred during the decline of breastfeeding that was observed during the late 1980s, when the gap reached 29.%. Since the 1990s, the disparity between WIC and non-WIC rates for initiation to breastfeed was >20%. For breastfeeding rates at 6 months of age, the disparities between WIC participants and non-WIC mothers steadily increased; since 1999, the disparities were >20%. For most years, twice as many mothers who were not enrolled in the WIC program than WIC participants continued to breastfeed their infants to 6 months of age.
The recent documented decline in breastfeeding initiation rates from 2002 to 2003 needs additional study. The decline in the initiation of breastfeeding did not occur evenly throughout the population but was greater in more vulnerable groups, that is, those who have historically been less likely to breastfeed. The decline was greater among WIC participants and those with less education and with a low birth weight infant.
In 2003, for the initiation of breastfeeding, increasing level of education, residing in the Western states, and not participating in WIC program were the strongest determinants. Weaker but significant positive predictors of breastfeeding initiation included normal birth weight, not working outside the home, and having a single child in the family (primiparous).
For breastfeeding at 6 months of age, participation in the WIC program was the strongest negative determinant compared with other demographic characteristics. Other significant but positive predictors of breastfeeding at 6 months of age included a college education, not working outside the home, living in the Western states, and having a normal birth weight infant. A previous study reported that the ORs for breastfeeding at 6 months of age for non-WIC mothers were 1.41 in 1984 and 1.78 in 1989.7 In 2003, the OR for breastfeeding at 6 months of age for non-WIC mothers was 2.11. Thus, it seems that WIC participation status had a greater impact on breastfeeding duration in 2003 than it did in the past.
The results presented here have limitations,1821 including the inability to control for income status and low response rate. Although information concerning income status was not collected, eligibility to participate in the WIC program is primarily based on income; the WIC variable serves as a reasonable surrogate for socioeconomic status. To be sure, families in certain demographic groups had lower rates of completion. These groups were, therefore, oversampled. Despite the low response rate, the RMS rates for breastfeeding are comparable with other national government surveys.1113 In addition, the magnitude and long-term consistency of the disparity of breastfeeding rates between WIC participants and non-WIC mothers make it unlikely that the differences are the result of chance.
The present study should not be considered an evaluation of the effectiveness of the WIC program. The study was not a controlled clinical trial. Rather, it used national survey data to compare WIC participants with mothers who were not enrolled in the WIC program. The nonparticipant group included mothers and infants from families with incomes too high to be eligible for WIC and also mothers and infants from families who may have been eligible for WIC but decided not to enroll. Nevertheless, the consistent and large disparity between WIC and non-WIC breastfeeding rates is one that bears intensive study and development of an effective response.
One of the biggest challenges for the WIC program is to achieve, across all regions of the country, the Healthy People 2010 goals for breastfeeding: 75% breastfeeding in the early postpartum period and 50% at 6 months.5 In 2003, for most subgroups of non-WIC mothers, rates for breastfeeding initiation exceeded the Healthy People 2010 goal of 75%. This was not the case for WIC participants, for whom rates for the initiation of breastfeeding were <50% in several subgroups (women who were younger in age, black, grade-school educated, had a low birth weight infant, and resided in the Middle Atlantic, East North Central, East South Central, and West South Central regions of the United States).
In 2003, for some groups of non-WIC mothers, rates of breastfeeding at 6 months of age exceeded the Healthy People 2010 goal (women of Asian descent and those living in the Pacific region). For WIC participants, again, much lower rates for breastfeeding at 6 months were observed, <20% in many subgroups (women who were black, <20 years of age, high-school educated, working full time, had a low birth weight infant, primiparous, and living in the South Atlantic, East North Central, East South Central, and West South Central regions of the country).
Most mothers understand that breastfeeding is best for their infants and for themselves.22 However, for both non-WIC mothers and WIC participants, there can be challenges to the initiation and duration of breastfeeding, including lack of education and support from family, friends, and health professionals2325; lack of confidence26; embarrassment23; and returning to work or school shortly after giving birth.27 For mothers in WIC, whereas they usually acknowledge the health benefits of breastfeeding, they may face significant barriers that are difficult to overcome.28
The WIC program has taken important steps in recent years to promote breastfeeding, and with targeted efforts the rates of breastfeeding in some communities have increased.17,2933 Such programs typically have been limited in number and scope, and the potential positive impact at the national level has not been observed.
Although the WIC program is committed to promoting breastfeeding as the optimal method of infant feeding, some researchers have questioned the impact of providing free infant formula to those who would benefit most from breastfeeding.34 Because participation in the WIC program is voluntary, it may be that mothers who have already made the decision to use formula are more likely to enroll in the program. This is a subject that needs additional study. The WIC program faces a number of challenges in encouraging such mothers to switch to breastfeeding.
Over the past 25 years, the WIC program has grown considerably. In fiscal year 1974 when WIC became a permanent program, WIC served an average of 88000 women, infants, and children per month.35 In 2003, the WIC program served an average of 7.6 million women, infants, and children per month.35 Although WIC is not an entitlement program, the number of individuals served is limited by the amount of funds appropriated to the program. At its inception, major health and nutritional risks faced by the WIC-eligible population included a relatively high prevalence of underweight,36 high prevalence of childhood iron-deficiency anemia,37 diets with low intakes of nutrients,35 and less access to health care38 and health care insurance.39 Participation in the WIC program has been associated with a number of positive health measures including improved birth outcomes (longer pregnancies, fewer premature births, fewer infant deaths),40 improved diet and diet-related outcomes (decreased prevalence of anemia, positive effects on intake of key nutrients),4143 improved rates of childhood immunization,44 and improved cognitive development of children.44 It has been estimated that for every dollar spent on prenatal WIC participation, $1.77 to $3.13 is saved within the first 60 days after birth in Medicaid costs.4547
Since its inception, the ethnic composition of the WIC program also has changed substantially.35 Hispanics constituted 38% of the WIC caseload in 2002 vs 21% in 1988.35 Asians and Pacific Islanders have become a larger part of the WIC population in several states.35 Despite the improvements in health and nutrition, the rates of breastfeeding in the WIC program have not increased relative to those of nonparticipants. This is surprising, considering that many more Hispanics, Asians, and Pacific Islanders are participating in the WIC program, populations that historically have had relatively high breastfeeding rates.
Another issue is the relatively greater monetary value of the food package for a formula-fed infant vs a breastfed infant. In a recent evaluation by the Institute of Medicine (IOM) Committee to Review the WIC Food Packages, large differences were reported in the monetary value of food packages provided to mothers who exclusively breastfeed, partially breastfeed, or exclusively formula feed their infants.35 The market value of the current food package for mother/infant pairs who formula feed exclusively is $1380 for the first year postpartum compared with only $668 for mothers who decide to exclusively breastfeed for the first year. The market value of the food package provided to mothers who decide to partially breastfeed (both formula and breast milk) is $1669 for the first year. The IOM Committee recommended changes to more strongly promote breastfeeding, including decreasing the disparity in value in the mother/infant food packages and decreasing the amount of formula provided to partially breastfeeding mothers.
The Department of Agriculture has 18 months from the release of the IOM report to issue a response. This is an opportunity for policy makers to take a closer look at the food package recommendations and explore ways in which the offerings can more strongly promote breastfeeding. There is a financial benefit to the WIC program if more WIC mothers decide to breastfeed. Two studies have estimated a savings for federal public assistance programs of more than $400 per infant per year for the infant who is breastfed.48,49
The maintenance of infant health has been the hallmark of our society; it is one of our best investments and greatest achievements. The current study documents that although breastfeeding rates in WIC have increased through the years, the increases have tracked with increases in the general population and that breastfeeding rates among WIC participants have always lagged behind those of nonparticipants. Furthermore, the recent decrease in breastfeeding rates was largest among WIC participants. With more infants participating in the WIC program than ever before, change is needed. Now may be the best time to implement food package and program changes that make the incentives for breastfeeding greater among WIC participants.
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| FOOTNOTES |
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Address correspondence to Wenjun Zhou, MS, Ross Products Division, Abbott Laboratories, 625 Cleveland Ave, Columbus, OH 43215. E-mail: wenjun.zhou{at}abbott.com
The authors have indicated they have no financial relationships relevant to this article to disclose.
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