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Randomized, Controlled Trial of a Prenatal and Postnatal Lactation

Consultant Intervention on Duration and Intensity of Breastfeeding up to


12 Months

Karen A. Bonuck, PhD*; Michelle Trombley, BA*; Katherine Freeman, DrPH*; and Diane McKee, MD‡

ABSTRACT. Objective. To determine whether an in- ABBREVIATIONS. WIC, Supplemental Nutrition Program for
dividualized, prenatal and postnatal, lactation consultant Women, Infants, and Children; OR, odds ratio; CI, confidence
intervention resulted in increased cumulative intensity interval; MILK, Moms Into Learning about Kids; LC, lactation
of breastfeeding up to 52 weeks. consultant; RA, research assistant.
Design. The randomized, nonblinded, controlled trial
recruited women from prenatal care. Baseline prenatal

T
interviews covered demographic data and breastfeeding he American Academy of Pediatrics recom-
experience, intention, and knowledge. Interviews at 1, 2, mends exclusive breastfeeding for 6 months
3, 4, 6, 8, 10, and 12 months after birth collected data on and continuation of partial breastfeeding for
weekly feeding patterns, infant illness, and infant health ⱖ12 months.1 The unique composition of breast
care use. milk has essential nutrients that are absorbed more
Setting. Two community health centers serving low- readily than cow’s milk or infant formula into the
income, primarily Hispanic and/or black women. infant’s bloodstream. Breast milk confers increased
Participants. The analytic sample included 304
immune function and is associated with the growth
women (intervention: n ⴝ 145; control: n ⴝ 159) with >1
postnatal interview. of human tissues, especially the brain.2 In the first 1
Intervention. Study lactation consultants attempted 2 year of life, in particular, breastfeeding is associ-
prenatal meetings, a postpartum hospital visit, and/or ated with significantly fewer cases of otitis media,3–7
home visits and telephone calls. Control subjects re- respiratory infections,7–12 and gastrointestinal ill-
ceived the standard of care. nesses.12–15
Outcome Measures. Cumulative breastfeeding inten- Healthy People 2010 set a goal that 75% of infants
sity at 13 and 52 weeks, based on self-reports of weekly be breastfed in the early postpartum period, with
feeding, on a 7-level scale. continued breastfeeding to 6 months for 50%.16
Results. The intervention group was more likely to Breastfeeding rates are generally higher among older
breastfeed through week 20 (53.0% vs 39.3%). Exclusive
breastfeeding rates were low and did not differ according
women, women of greater income and education,
to group. In multivariate analyses, control subjects had and women who are not black.17,18 From 1990 to 2001
lower breastfeeding intensity at 13 weeks (odds ratio there were dramatic increases in any breastfeeding to
[OR]: 1.90; 95% confidence interval [CI]: 1.13–3.20) and 52 69.5% (from 52%) in the hospital and 32.5% (from
weeks (OR: 2.50; 95% CI: 1.48 – 4.21). US-born control 18%) at 6 months. Exclusive breastfeeding during
subjects had lowest breastfeeding intensity at 13 weeks this period increased to 46.3% (from 43.5%) in the
(OR: 5.22; 95% CI: 2.43–11.22) and 52 weeks (OR: 5.25; hospital and 17.2% (from 10.4%) at 6 months. The
95% CI: 2.44 –11.29). There were no significant differ- greatest initiation gains were among women who
ences in breastfeeding intensity among the US-born in- were black, younger (⬍20 years of age), high school
tervention, foreign-born intervention, and foreign-born
educated or less, and receiving Supplemental Nutri-
control groups.
Conclusions. This “best-practices” intervention was tion Program for Women, Infants, and Children
effective in increasing breastfeeding duration and inten- (WIC) benefits. At 6 months, exclusivity was lower
sity. Breastfeeding promotion should focus on US-born among black versus white non-Hispanic and His-
women and exclusive breastfeeding. Pediatrics 2005;116: panic women (10.7% vs 18.7% and 16.2%, respec-
1413–1426; randomized, controlled trial, breastfeeding du- tively), younger women (10.3% for women ⬍20 years
ration, intensity of breastfeeding, exclusive breastfeeding, of age vs 22% for women ⬎35 years of age), and
lactation consultant. women lacking a college degree (24% for college vs
12.7% for high school).19 Recently published 2002
National Immunization Survey data found similar
From the Departments of *Epidemiology and Population Health and ‡Fam- results; Li et al18 recommended that strenuous public
ily and Community Medicine, Montefiore Medical Center/Albert Einstein
health efforts target non-Hispanic black women and
College of Medicine, Bronx, New York.
Accepted for publication May 5, 2005. socioeconomically disadvantaged groups.
doi:10.1542/peds.2005-0435 A US Preventive Services Task Force meta-analysis
No conflict of interest declared. found that combined education, counseling, and
Reprint requests to (K.A.B.) Department of Epidemiology and Population problem-solving were most effective for promoting
Health, Montefiore Medical Center/Albert Einstein College of Medicine,
111 E 210th St, Bronx, NY 10467. E-mail: kbonuck@montefiore.org
breastfeeding in the first 3 months, whereas ongoing
PEDIATRICS (ISSN 0031 4005). Copyright © 2005 by the American Acad- support through in-person visits or telephone con-
emy of Pediatrics. tacts increased duration to 6 months.20 Brief, small-

PEDIATRICS Vol. 116 No. 6 December 2005


Downloaded from www.aappublications.org/news at Indonesia:AAP Sponsored on November 16, 2020
1413
scale interventions and those without face-to-face plans to remain in the center and its affiliated hospital system for
interactions were generally ineffective, according to prenatal and infant care up to 12 months, ⱖ2 contact telephone
numbers, and gestation before 24 weeks (to allow sufficient time
a systematic review.21 Hands-on assistance with to deliver the 2-part prenatal intervention). Exclusion criteria in-
breastfeeding techniques, demand feeding, and post- cluded HIV-positive status,30 chronic therapy with medications
natal support are essential postpartum factors, ac- incompatible with breastfeeding, and pregestational diabetes mel-
cording to several reviews of controlled clinical tri- litus; diabetic prenatal patients were referred to a high-risk site for
care. Although they are not generally considered contraindica-
als.22–24 Women value being shown how to feed their tions,1 women with human T-cell leukemia virus-1, breast reduc-
infants, rather than being told how to, as found in tion surgery, or hepatitis B or C were excluded, given some
our previous work25 and by others.26 Support offered controversy that might have predisposed affected women and
by trained volunteers had no effect in a large, ran- their health care providers against breastfeeding.
domized, clinical trial of women intending to breast- All study materials were translated professionally into Spanish.
These translations were checked for cultural concordance with
feed,27 underscoring the value of offering postnatal local dialects by native Spanish-speaking study staff members.
support routinely, compared with on demand. The study was approved by the medial center’s institutional re-
Although the literature is replete with breastfeed- view board for the protection of human subjects.
ing-promotion intervention studies, few are good-
quality, randomized, controlled trials of best prac- Randomization and Referral for Intervention
tices. In preparing its meta-analysis, the US After consent, eligible women who agreed to participate were
Preventive Services Task Force systematically re- assigned randomly to the intervention or control group, with an
undisclosed blocking factor and stratification according to center.
viewed studies of counseling or behavioral interven- The project’s biostatistical office generated and maintained a list of
tions originating from clinicians’ practices. Eligible random codes for subjects, corresponding to the intervention and
studies included physician, nurse, lactation consul- control assignment groups. A page with the subject’s identifica-
tant (LC), or peer counselor interventions occurring tion number, treatment assignment, and administrative informa-
tion (eg, date assigned) was generated for each subject. Each page
in the clinic, hospital, or home or elsewhere. An was secured in a sealed envelope and labeled externally with the
exhaustive search of 1996 –2001 articles yielded just subject number, name of the study, and study contact information.
22 randomized, controlled trials, only 1 of which was Series of envelopes were given to the RA at the site, with instruc-
judged to be of good quality. Of these 22 studies, just tions to open the envelopes in sequence and to assign the women
7 included follow-up monitoring for ⱖ4 months, to the corresponding intervention or control group.
After intervention group participants completed the baseline
only 8 included both educational and supportive interview, the MILK RA referred them to the study LC. The RA
elements, and just 2 provided both prepartum and shared basic demographic and contact information but did not
postpartum interventions.28 discuss the breastfeeding intentions, knowledge, or attitudes as-
We conducted a randomized, nonblinded, con- sessed at the baseline interview. The LC then sought to arrange a
first meeting with the participant, either at the center during an
trolled trial of a breastfeeding-promotion interven- upcoming visit or at her home.
tion, compared with standard care, in community
health centers where women received their prenatal Trial Enrollment
and postpartum care. The intervention combined As shown in Fig 1 (MILK Trial enrollment flow chart), a total of
several best-practice interventions; it offered profes- 382 women (385 mother/infant dyads, with 3 sets of twins) were
sional, one-on-one, skills-based, prenatal and postna- assigned randomly in the study (intervention: n ⫽ 188; control: n
tal education and support routinely. Intention to ⫽ 194). Of these, 21 mother/infant dyads were excluded at contact
for postnatal follow-up monitoring (intervention: n ⫽ 15; control:
breastfeed at prenatal baseline was assessed in both n ⫽ 6). Exclusions included mothers of twins (a decision was made
groups. Weekly breastfeeding outcomes up to 12 after data collection was complete to exclude them from analyses;
months were assessed in both groups with a stan- intervention: n ⫽ 2; control: n ⫽ 1), women who chose to with-
dardized tool that measured 7 levels of breastfeed- draw from the study (intervention: n ⫽ 3; control: n ⫽ 2), and
women who miscarried or terminated their pregnancy (interven-
ing, ranging from exclusive to none. The study was tion: n ⫽ 8; control: n ⫽ 2) after baseline assessment. Among the
conducted in the Bronx, New York, the US county remaining eligible women, 30 from each group (17% of the inter-
with the highest poverty rate and lowest median vention group and 16% of the control group) were lost to all
household income. Nearly one half (48%) of the follow-up monitoring. The outcomes sample represents 79.6% of
Bronx population is Hispanic; just 15% of residents
identified themselves as non-Hispanic white in the
2000 US Census.29

METHODS
Recruitment and Eligibility
The Moms Into Learning about Kids (MILK) study was a ran-
domized, controlled trial of a multicomponent breastfeeding-pro-
motion intervention. Breastfeeding, infant health, and infant
health care utilization outcomes were tracked up to 12 months.
This article reports on breastfeeding outcomes. Prenatal care pa-
tients at 2 hospital-affiliated health centers in the Bronx, New
York, were recruited from August 2000 through November 2002.
At 1 site, a research assistant (RA) bilingual in English and Span-
ish recruited directly from the center’s mandatory prenatal class.
At the other center, social work staff members recruited interested Fig 1. Trial enrollment flow chart. *These 382 women included 3
participants and passed contact information onto another bilin- women pregnant with twins, ie, 385 mother/infant dyads. Subse-
gual MILK RA. quently, these 3 mothers (2 in the intervention group and 1 in the
Eligibility criteria included the following: English or Spanish control group) were deemed ineligible, which resulted in 6 exclu-
speaking, twin or singleton pregnancy, intent to keep the infant, sions from the analytic sample.

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all those assigned randomly and 83.5% of eligible women after floors of the hospital that served as the delivery site for both health
exclusions. Data were not collected for women who were ap- centers. LCs also telephoned intervention group women weekly as
proached but did not enroll. their expected delivery date neared. Initial hospital and home
Therefore, a total of 304 women (intervention: n ⫽ 145; control: visits provided hands-on instruction in latching on, proper posi-
n ⫽ 159) with ⱖ1 postnatal follow-up data point were included in tioning, and other techniques to avoid common breastfeeding
the final analysis (outcomes sample). The mean lengths of fol- complications, as well as pump use. After breastfeeding was es-
low-up periods for the outcomes sample were 41 weeks (SD: 16.3 tablished, topics included frequency of feeding, confidence, stool-
weeks) for the intervention group and 44 weeks (SD: 13.9 weeks) ing patterns, determining adequate intake, and maternal nutrition.
for the control group. At 13 weeks, follow-up data were available If later contacts were made, they tended to focus on expressing
for 90% of the outcomes sample intervention group and 92% of the and storing milk, fatigue, nursing in public, returning to school or
outcomes sample control group. Follow-up rates decreased but work, and supplementing. The LCs helped mothers garner sup-
remained comparable between the intervention and control port from their families, schools, workplaces, and health care
groups at 26 weeks (79% vs 87%), 39 weeks (70% vs 79%), 48 providers.
weeks (63% vs 67%), and 52 weeks (52% vs 59%). We compared Study LCs offered a nursing bra to women in the intervention
participants who were retained with those who were lost to fol- group, free of charge, to facilitate breastfeeding. Study LCs also
low-up monitoring at those times, both within and across treat- provided manual (Spring Express manual breast pump system;
ment groups in terms of age, education, foreign birth, race/eth- Medela, McHenry, IL) or minielectric (Medela) breast pumps to
nicity, marriage/partner status, Medicaid, parity, prior women, free of charge, in certain circumstances. Women who
breastfeeding experience, and infant feeding intention at baseline. were separated from their infants because of work, school, or
None of these differences was statistically significant (data not travel were given minielectric pumps. Women who were not
shown). separated from their infants for long periods but wanted the
freedom to go out for several hours were given a manual pump.
Data Collection The general policy of the study LCs was to discourage the use of
breast pumps in favor of nursing for women who were in contin-
Data collection consisted of 1 prenatal baseline interview cov-
ual proximity to their infants.
ering demographic data, previous breastfeeding experience, feed-
The 2 study LCs maintained detailed activity logs for the
ing intention, and breastfeeding knowledge and 8 telephone in-
women assigned to them. These logs recorded the dates and sites
terviews, at 1, 2, 3, 4, 6, 8, 10, and 12 months after birth, to assess
(eg, clinic, home, or hospital) of all attempted and actual contacts
infant feeding. The 1-month follow-up interview collected de-
and telephone calls, duration of contact (minutes), supplies deliv-
tailed data about the immediate postpartum experience, including
ered, and content of contact.
infant feeding in the hospital and during the first week, the
Control group women had no contact with the study LCs.
infant’s health, and health care use. Interviews at months 2, 3, 4, 6,
Control subjects received the health center standard of care. At
8, 10, and 12 were briefer and focused primarily on weekly feed-
one site, this included a mandatory prenatal care class, which did
ing, infant health care, and health care use.
not address infant feeding in any detail. At the other site, there
At the site where a MILK RA recruited directly from the pre-
was no routine prenatal education. Neither site followed an estab-
natal class, the RA attempted to complete the baseline interview
lished protocol for breastfeeding education or support or offered a
just after recruitment or at the next prenatal visit. At the site that
private lactation space. Participants enrolled in WIC had the op-
relied on social work referrals, interested participants were met at
portunity to visit with a breastfeeding coordinator at the WIC site,
their next prenatal visit. Participants were given gift cards for
although such use was not assessed specifically. Given the study
$20.00 after completion of the baseline interview, $40.00 after
population’s diversity, it would be difficult to characterize a com-
completion of follow-up interviews at 1, 2, 3, and 4 months, and
munity “standard” with respect to breastfeeding.
$55.00 after completion of the remaining interviews.

Blinding Assessment of Breastfeeding Outcomes


Breastfeeding was measured through maternal self-report. At
Neither the RA collecting breastfeeding outcome data nor the
each follow-up interview, participants reported breastfeeding sta-
study LCs providing the intervention were blinded with respect to
tus for each week since their last interview or since hospital
treatment group. However, the study protocol prohibited any
discharge (at the first follow-up interview). Breastfeeding status
discussion or sharing of feeding data between the study RAs and
was assessed with the Index of Breastfeeding Status, a measure
the study LCs.
that has been used by others.31–34 The Index of Breastfeeding
Status is a 7-level ordinal scale that measures the percentage of
Power Analysis breast milk an infant receives, compared with the total amount of
The power analysis was based on the following assumptions: feedings. These 7 levels are mutually exclusive (level 1, 100%
29% of mothers without the intervention would initiate breast- breast milk; level 2, ⱖ80% breast milk combined with ⬍20%
feeding, compared with twice that proportion in the intervention artificial milk or solids; level 3, 50 – 80% breast milk and the rest
group. With these assumptions, 52 women per group, or 104 artificial milk or solids [ie, 2–5 of every 10 feedings are not breast
women total at each center, were needed to detect a difference milk]; level 4, 50% breast milk and 50% artificial milk or solids;
with ␣ ⫽ .05 and ␤ ⫽ .20 (2-tailed test). level 5, 20 –50% breast milk and the rest artificial milk or solids
[5– 8 of every 10 feedings are not breast milk]; level 6, ⱕ20% breast
Description of the Intervention milk combined with ⬎80% artificial milk or solids; level 7, 100%
artificial milk or solids [includes weaned]). Exclusive breastfeed-
Prenatal ing is defined as level 1. Exclusive formula feeding is defined as
A study LC attempted 2 individual meetings with each inter- level 7. Analyses that report majority (ⱖ50%) breastfeeding in-
vention group woman prenatally and postpartum hospital and clude levels 1 to 4. When data are presented as 5 feeding levels for
home visits and was available for telephone consultation up to 12 ease of presentation, levels 2 and 3 are combined, as are levels 5
months. The initial prenatal meeting focused first on trust and and 6. For our study, exclusive breastfeeding was defined as no
rapport and then educational content. The LC assessed feeding artificial milk or solids. Intake of water, liquids other than artificial
intentions and discussed the benefits of breastfeeding. A flip-chart milk, and vitamin drops was not assessed. The next section de-
depicting the physiologic features of breastfeeding and color pam- scribes how these data were used to construct a measure of
phlets were reviewed. The second meeting addressed what to breastfeeding intensity.
expect after birth and specifics on how to initiate breastfeeding in
the hospital (eg, latch-on, positioning, importance of early initia- Statistical Analyses
tion, and demand feeding). Practice with a culturally appropriate
We compared participants who were assigned randomly and
lactation doll and nipple was offered.
included in the final analyses (outcomes sample) with participants
who were assigned and not included in the final analyses, both
Postnatal within and across treatment groups. The outcomes sample was
We sought to identify women in the hospital for LC visits composed of women with ⱖ1 postnatal follow-up data point.
through daily faxes regarding women on the labor and delivery Differences between women assigned to the intervention group

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ARTICLES 1415
and women assigned to the control group were tested for signif- according to treatment group and country of origin. Differences
icance with t tests (for maternal age), ␹2 tests for dichotomous according to treatment group and country of origin were analyzed
outcomes, and the Mantel-Haenszel test for trend for breastfeed- with analysis of variance, with Duncan multiple comparisons.
ing intention, a trichotomous ordinal variable. Descriptive statis- Lastly, both TOTAL13 and TOTAL52 were dichotomized at
tics are shown as mean (SD) or number (percentage). their medians. Logistic regression models were derived with the
All remaining data descriptions and analyses were based on the dichotomized intensity scores as outcomes and the set of signifi-
outcomes sample of 304 women. Unadjusted differences between cant covariates, the treatment group, and the interaction between
the intervention and control groups were tested for significance as treatment group and country of origin as independent factors.
described above. A comparison of baseline data from the 2 sites Odds ratios (ORs) and 95% confidence intervals (CIs) are pre-
found no significant differences for the 60 baseline variables as- sented.
sessed, except that foreign birth was somewhat collinear with All significance testing was based on 2-tailed tests, with P ⬍ .05
site.35 Therefore, with data for the 2 sites pooled, multivariate denoting significance. Analyses used an intention-to-treat model.
analyses controlled for foreign birth. Client tracking data were entered and maintained centrally by
We created a breastfeeding intensity score over 52 weeks by study staff members, in an administrative database. Baseline and
summing weekly scores (range of 1–7, with 7 being exclusive follow-up interviews were scanned with Teleform Elite 8.0 soft-
formula feeding). For subjects with missing values before a given ware (Cardiff Software, Bozeman, MT). Data were then trans-
week, we imputed the treatment group’s median value for that ferred to SAS software, version 8.2 (SAS Institute, Cary, NC), for
week. Similarly, for subjects with missing values later than a given analysis.
week, we imputed the treatment group’s subsequent weekly me-
dian values. The sum of weekly intensity scores was derived for
each subject through week 13 (TOTAL13) and through week 52 RESULTS
(TOTAL52), with minimum to maximum ranges of 13 to 91 and 52
to 364, respectively. Baseline Characteristics
Bivariate associations between each total intensity score and
variables related to breastfeeding were assessed with Wilcoxon
Baseline characteristics are shown in Table 1.
rank sum tests for dichotomous variables and Spearman rank There were no significant differences between
correlations for continuous variables. These variables included women included in the final analysis of outcomes
Medicaid status, breastfeeding intention at baseline, logarithm of and those assigned randomly but not included in the
age, age squared (to assess for a nonlinear effect of age), education, final analysis, within or across treatment groups.
marital status, race/ethnicity, country of origin (US mainland
versus other), prior breastfeeding, and recruitment site. Variables Unless otherwise specified, all remaining results are
with associations yielding P values of ⬍.20 were used in initial reported for the outcomes sample.
multivariate models. Models were analyzed with and without (for The mean age of mothers was 25 years (SD: 6.23
ease of interpretation) transformations of scale for non-normally years), 61.5% had a high school degree, 51.5% were
distributed variables, with backward stepwise multiple regres-
sion. There were no interaction terms in initial models. With data married or living with a partner, and nearly 40%
from all subjects regardless of treatment group, covariates with were foreign born. The sample was primarily His-
associations of P ⬍ .05 were retained in subsequent multivariate panic (57%) and black (36%). The majority (57%) of
models, to assess the significance of the intervention. Initial mod- women were receiving Medicaid. Nearly two thirds
els were divided into those with (baseline parity of ⱖ1) and
without (entire sample) the prior breastfeeding variable. (63%) had other children, and 70% reported prior
We examined race/ethnicity and country of origin interactions breastfeeding experience. Breastfeeding intentions
with treatment group, given our prior findings36 and interest in were as follows: breast milk only, 30%; combined
determining whether specific subpopulations benefited differen- breast milk and formula, 49%; exclusive formula
tially from the intervention. This effect modification was signifi-
cant according to country of origin but not race/ethnicity. Unad-
feeding, 9%.
justed TOTAL13 and TOTAL52 scores are presented for both the Twenty-six women completed the Spanish-lan-
entire sample and subjects with baseline parity of ⱖ1, stratified guage version of the baseline instrument. Some

TABLE 1. Baseline Characteristics


Variable Values Percentage (No.)
Intervention Control Sample
Assigned* Outcomes† Assigned Outcomes Assigned Outcomes
(n ⫽ 188) (n ⫽ 145) (n ⫽ 194) (n ⫽ 159) (n ⫽ 382) (n ⫽ 304)
Age, y Mean ⫾ SD 25.68 ⫾ 6.38 25.48 ⫾ 6.39 24.84 ⫾ 5.86 24.99 ⫾ 6.09 25.25 ⫾ 6.13 25.22 ⫾ 6.23
High school Yes 58.5 (110) 58.6 (85) 63.4 (123) 64.2 (102) 61.0 (233) 61.5 (187)
Married/partner Yes 50.3 (94) 49.3 (71) 54.6 (106) 53.5 (85) 52.5 (200) 51.5 (156)
Foreign born Yes 44.1 (83) 44.1 (64) 34.5 (67) 35.2 (56) 39.3 (150) 39.5 (120)
Race/ethnic Black 35.6 (67) 35.9 (52) 38.7 (75) 36.5 (58) 37.2 (142) 36.2 (110)
Hispanic 54.8 (103) 56.6 (82) 55.2 (107) 56.6 (90) 55.0 (210) 56.6 (172)
Other 9.6 (18) 7.6 (11) 6.2 (12) 6.9 (11) 7.9 (30) 7.2 (22)
Medicaid Yes 53.7 (101) 52.4 (76) 58.2 (113) 61.0 (97) 56.0 (214) 56.9 (173)
Parity Other children 59.9 (109) 60.7 (85) 62.0 (116) 64.5 (98) 61.0 (225) 62.7 (183)
Breastfed before Yes 67.9 (74) 71.8 (61) 67.8 (80) 68.7 (68) 67.8 (154) 70.1 (129)
Intentions Only breast milk 33.0 (62) 28.9 (56) 32.4 (47) 28.3 (45) 30.9 (118) 30.3 (92)
Both 47.3 (89) 47.4 (92) 50.3 (73) 48.4 (77) 47.4 (181) 49.3 (150)
Only formula 8.5 (16) 10.3 (20) 7.6 (11) 9.4 (15) 9.4 (36) 8.6 (26)
Do not know 11.2 (21) 13.4 (26) 9.7 (14) 13.8 (22) 12.3 (47) 11.8 (36)
For each variable shown, both within-group differences and between-group differences among those assigned randomly versus those in
the outcomes data were tested for significance with ␹2 tests. None of these associations was significant at the .05 level.
* “Assigned” includes all women assigned randomly in the study.
† “Outcomes” includes mother/infant dyads included in the outcome data in the remaining tables. The following mother/infant dyads
were excluded from outcome analyses: women who lost the fetus (n ⫽ 9), lost custody/were separated from the infant (n ⫽ 1), changed
their minds (n ⫽ 5), or had twin births (n ⫽ 3) or for whom no breastfeeding outcome data were obtained (n ⫽ 60).

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women completed both English and Spanish ver- Intervention Dose and Median Breastfeeding Intensity
sions of study instruments throughout the study. Table 3 presents descriptive data on components
of intervention received, ie, “dose,” for the 145
Birth and Postpartum Experiences women in the intervention group outcomes sample
and their corresponding TOTAL13 scores. Overall,
Detailed data about the birth and immediate post-
81% (n ⫽ 117) received any intervention. Sixty-four
partum experience were obtained at the 1-month
percent had prenatal interventions, 63% had postna-
follow-up interview (Table 2). There were no signif-
tal interventions, and 47% had both prenatal and
icant differences between the groups in any of the
postnatal interventions. Approximately twice as
variables related to birth or infant morbidity, eg,
many women had a postnatal home visit (49%) or
delivery time, infant discharged with mother, birth
type, low birth weight, time in NICU, or maternal telephone call (55%), compared with a hospital visit
perception of newborn health problems. The health (25%). Study LCs spent a mean of 111 minutes in
centers’ affiliated hospital was the delivery site for prenatal contact among the 93 women with any pre-
85% of births. natal contact and a mean of 139 minutes in postnatal
At the 1-month follow-up interview, we also ob- contact among the 92 women with any postnatal
tained data about when women considered their contact. Mean dose times averaged across all 145
feeding choice, prenatal care providers, and hospital women (ie, intention to treat) are also shown.
practices pertaining to feeding and onset of breast- Unadjusted TOTAL13 scores are shown for partic-
feeding. Again, there were no significant differences ipants who received any of that intervention compo-
between groups. Two thirds (67%) of women had nent; women who received a hospital visit from the
first thought about their feeding choice by the end of LC might or might not have received home visits
the first trimester. However, less than one half (43%) and/or telephone calls. Scores were similar for
reported receiving advice about breastfeeding from women who received 2 prenatal contacts (TOTAL13:
their prenatal care providers. Eighty-four percent 60.0), according to the protocol, compared with
“roomed in” with their infants. Hospital staff mem- women who received either 1 or 2 prenatal contacts
bers asked 73% of women if they wanted to breast- (TOTAL13: 61.0). Women who received a home visit
feed immediately after the birth. Although more from the LC had a lower score (TOTAL13: 49.0),
women in the intervention group (62%) attempted to indicative of greater breastfeeding, than did women
breastfeed in the first 4 hours, compared with control who did not. However, these unadjusted data must
subjects (52%), this difference was not significant. be interpreted with caution.
There was no association between maternal percep- To facilitate breastfeeding, women in the interven-
tion of newborn illness and either breastfeeding tion group were offered nursing bras and breast
within the first 4 hours after birth or any subsequent pumps, free of charge. Nursing bras were given to
breastfeeding at 2, 4, or 13 weeks (data not shown). 52 women. A total of 64 breast pumps (52 minielec-

TABLE 2. Birth and Postpartum Experiences


Variable Values Percentage (No.) P*
Intervention Control Sample
Study hospital (n ⫽ 301; missing: n ⫽ 3) Yes 84.0 (121) 85.4 (134) 84.7 (255) .750
No 16.0 (23) 14.6 (23) 15.3 (46)
Delivery time (n ⫽ 257; missing: n ⫽ 47) Day 53.3 (65) 42.2 (57) 47.5 (122) .076
Night 46.7 (57) 57.8 (78) 52.5 (135)
Left hospital with mother (n ⫽ 301; missing: n ⫽ 3) Yes 86.1 (124) 86.6 (136) 86.4 (260) .862
No 13.9 (20) 13.4 (21) 13.6 (41)
Birth type (n ⫽ 301; missing: n ⫽ 3) Vaginal 81.3 (117) 77.7 (122) 79.4 (239) .448
Cesarean 18.8 (27) 22.3 (35) 20.6 (62)
Birth weight (n ⫽ 301; missing: n ⫽ 3) Low birth weight 8.3 (12) 7.6 (12) 8.0 (24) .825
Normal weight 91.7 (132) 92.4 (145) 92.0 (277)
NICU (n ⫽ 301; missing: n ⫽ 3) Yes 14.6 (21) 12.1 (19) 13.3 (40) .526
No 85.4 (123) 87.9 (138) 86.7 (261)
Newborn health problems (n ⫽ 301; missing: n ⫽ 3) Yes 25.0 (36) 24.8 (39) 24.9 (75) .975
No 75.0 (108) 75.2 (118) 75.1 (226)
Roomed in (n ⫽ 301; missing: n ⫽ 3) Yes 83.3 (120) 84.1 (132) 83.7 (52) .862
No 16.7 (24) 15.9 (25) 16.3 (49)
First breastfeeding attempt (n ⫽ 263; missing: n ⫽ 41) 0–4 h 61.7 (82) 52.3 (68) 57.0 (150) .126
⬎4 h 38.2 (51) 47.7 (62) 43.0 (113)
Advised on breastfeeding by prenatal care provider Yes 43.1 (62) 43.3 (68) 43.2 (130) .964
(n ⫽ 301; missing: n ⫽ 3) No 56.9 (82) 56.7 (89) 56.8 (171)
Asked if wanted to nurse in delivery room by Yes 72.9 (97) 73.9 (116) 73.4 (213) .855
hospital staff (n ⫽ 290; missing: n ⫽ 14) No 27.1 (36) 26.1 (41) 26.6 (77)
When first considered how to feed infant (n ⫽ 299; Before pregnancy 21.7 (31) 18.6 (29) 20.1 (60) .956
missing: n ⫽ 5) First trimester 48.3 (69) 46.2 (72) 47.2 (141)
Later 30.1 (43) 35.3 (55) 32.8 (98)
* For each variable shown, both within-group differences and between-group differences for the assigned group versus the outcomes
sample were tested for significance with ␹2 tests. None of these associations was significant at the .05 level.

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ARTICLES 1417
TABLE 3. Intervention “Dose” and Breastfeeding Intensity at 13 Weeks
Intervention Subjects Receiving Dose* Dose Among All Median 13-wk
Intervention Subjects Breastfeeding Intensity
Percentage Dose Received, min, (n ⫽ 145), min, Scores† by Dose
(No.) Mean ⫾ SD Mean ⫾ SD Received
Prenatal
Any 64.1 (93) 110.70 ⫾ 25.82 65.1 ⫾ 57.53 61.0
2 prenatal visits 53.1 (77) 58.0 ⫾ 60.93 60.0
Postnatal
Any 63.4 (92) 138.92 ⫾ 74.96 78.2 ⫾ 87.00 54.5
Hospital visits 24.8 (36) 76.69 ⫾ 39.07 17.1 ⫾ 36.63 58.5
Home visits 49.0 (71) 73.31 ⫾ 32.51 32.4 ⫾ 42.17 49.0
Telephone calls 55.2 (80) 60.19 ⫾ 34.36 28.4 ⫾ 38.12 53.0
Prenatal and postnatal
Any 80.7 (117) 197.23 ⫾ 105.20 143.2 ⫾ 122.38 60.0
Both 46.9 (68) 78.2 ⫾ 87.00 58.5
* Data are based on the 145 intervention group women in the outcomes sample. Nineteen percent (n ⫽ 28) of intervention group women
in the outcomes sample did not have any contact with the LC.
† Higher values indicate greater intensity of formula feeding, and lower values indicate greater intensity of breastfeeding. The range of
intensity scores at 13 weeks was 13 to 91.

tric pumps and 12 manual pumps) were given out. A significantly more likely to breastfeed at each week
few women required the use of a supplemental nurs- up to and including week 20 (53.0% vs 39.3%; P ⬍
ing system (n ⫽ 3) to induce lactation (data not .028), with the exception of week 18. At 21 weeks (⬃5
shown). months), 51.7% of the intervention group was still
breastfeeding. At the end of 12 months, 18% of the
Weekly Breastfeeding Outcomes intervention group and 15% of the control group
Any Breastfeeding continued to breastfeed.
Figure 2 presents data on any breastfeeding and
ⱖ50% breastfeeding, according to treatment group,
for selected weekly intervals up to 52 weeks. At 2 Breastfeeding of ⱖ50%
weeks, nearly 90% of the intervention group was Significantly more women in the intervention
breastfeeding, compared with 65% of the control group gave ⱖ50% breast milk feedings in the first 1
group. The steepest decline in breastfeeding oc- week after birth (69% vs 47%; P ⬍ .001). More than
curred between 2 and 6 weeks, when rates decreased one half of the intervention group gave their infants
by 15% and 10% in the intervention and control ⱖ50% breast milk through the first 6 weeks after
groups, respectively. The intervention group was birth. Group differences remained significant for

Fig 2. Any and ⱖ50% breastfeeding, according to treatment group. Breastfeeding of ⱖ50% was significant up to and including week 9
(P ⬍ .03). Any breastfeeding was significant up to and including week 20 (P ⬍ .028), except for week 18.

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each week up to and including week 9 (45.8% vs and the subsample (OR: 4.47; 95% CI: 2.13–9.36),
33.1%; P ⬍ .030). compared with 13 weeks for both the entire sample
(OR: 1.90; 95% CI: 1.13–3.20) and the subsample (OR:
Breastfeeding Intensity in Weeks 1 to 52 3.71; 95% CI: 1.81–7.59). As noted above, estimates
Figure 3 presents descriptive, unadjusted, weekly for covariates were essentially unchanged from the
feeding data for the intervention group (Fig 3A) and model excluding the interaction between treatment
the control group (Fig 3B). Data are shown for 5 group and country of origin.
levels of breastfeeding intensity, reduced from 7, ie, With respect to other significant covariates,
exclusive breastfeeding, more breast milk than for- women intending to formula feed exclusively at
mula, equal breast milk and formula, less breast milk baseline had significantly greater risk of low breast-
than formula, or exclusive formula feeding. Exclu- feeding at 13 weeks in the entire sample (OR: 10.51;
sive breastfeeding rates, which peaked at 2 weeks 95% CI: 2.97–37.15), compared with women intend-
(intervention: 20%; control: 19%), decreased at 6 ing exclusive breastfeeding, with similar results in
weeks (intervention; 15%; control: 16%), and contin- the other 3 models. Intent to combine formula and
ued to decline at 13 weeks (intervention: 9%; control: breastfeeding was not associated significantly with
11%), 26 weeks (intervention: 5%; control: 8%), and risk of low breastfeeding in 3 of the 4 models.
52 weeks (intervention: 6%; control: 5%), were not Women who were undecided about their feeding
significantly different at any of the 52 weeks ob- choice had a greater risk of low breastfeeding at 13
served (data not shown). and 52 weeks in the entire sample but not in the
Table 4 presents unadjusted TOTAL13 and TO- subsample with parity of ⱖ1. Older age, both dichot-
TAL52 scores stratified according to treatment group omized at 24 years and as a continuous variable, was
and country of origin. Separate scores are shown for associated with reduced risk of low breastfeeding.
participants according to parity (total sample vs par- Black women had significantly reduced risk of low
ity of ⱖ1 at baseline) to permit inclusion of the vari- breastfeeding at 13 weeks (OR: 0.44; 95% CI: 0.24 –
able for prior breastfeeding. US-born control subjects 0.79) and 52 weeks (OR: 0.37; 95% CI: 0.20 – 0.67),
had significantly higher scores than did the foreign- compared with a Hispanic reference group. Among
born control, foreign-born intervention, or US-born women with other children, not having breastfed a
intervention groups (P ⬍ .05). No other treatment previous child was significant at 52 weeks (OR: 2.91;
groups, according to country of origin, differed sig- 95% CI: 1.24 – 6.83) but not 13 weeks.
nificantly from one another. Higher 52-week scores
for all groups indicated the progression to greater DISCUSSION
formula feeding. We performed a randomized, controlled trial of an
We performed multiple logistic regression analysis individualized, LC, prenatal and postnatal, breast-
of the dichotomized median breastfeeding intensity feeding-promotion intervention modeled on best
scores, stratified according to week and parity. Re- practices found in the literature. At 3 and 12 months,
sults shown in Table 5 include the interaction be- control subjects receiving standard care in urban pri-
tween treatment group and country of origin. Effects mary care health centers had 90% and 150% in-
of the remaining covariates were essentially un- creased risk of low breastfeeding, respectively, com-
changed in a logistic regression model excluding this pared with the intervention group. The intervention
interaction. Thus, Table 5 presents only the treatment group achieved the Healthy People 2000 goal of 50%
group effect from that model. ORs adjusted for sig- continued breastfeeding up to 5 or 6 months37 but
nificant covariates, 95% CIs, and estimated R2 values did not sustain this level at 6 months, which is the
are presented for the 4 models. The OR indicates the Healthy People 2010 goal.16 By comparison, the con-
“risk” of low versus high levels of breastfeeding, trol subjects’ 6-month breastfeeding rate of 33%
compared with the reference category. matched national survey data from one source exact-
The intervention’s effect was modified signifi- ly19 and approximated the rate from another national
cantly by country of origin in multivariate analysis. data source (36%).38 Unfortunately, we observed
US-born control subjects had significantly greater similar rates of exclusive breastfeeding in the 2
risk of low breastfeeding at 13 weeks in both the groups, which suggests that the intervention was not
entire sample (OR: 5.22; 95% CI: 2.43–11.22) and the effective in helping women to breastfeed exclusively.
subsample (OR: 7.66; 95% CI: 2.75–21.36), compared Exclusive breastfeeding, which peaked at 20% at 2
with the foreign-born women in the intervention weeks in our study, was proposed as a Healthy
group. Similar results were found at 52 weeks. People 2010 goal in the mid-course review.39
Among the foreign-born women, there was no sig- Our most striking finding was the strength with
nificant difference between the intervention group which country of origin modified the effect of treat-
and the control group, neither of which differed from ment group. Our previous work on feeding inten-
US-born women in the intervention group. There- tions36 and other work on breastfeeding initiation40
fore, the intervention reduced the risk of low breast- and ever breastfeeding41 found that foreign-born
feeding among US-born women to the levels found women in the United States are predisposed to
in foreign-born women. breastfeed, compared with their native-born counter-
In analyses without the interaction term, control parts. In this study, US-born women were 5 to 8
subjects had greater risk of low breastfeeding levels, times as likely to have low breastfeeding intensity,
across the 4 models. ORs were greater at 52 weeks for depending on observation period and parity, com-
both the entire sample (OR: 2.50; 95% CI: 1.48 – 4.21) pared with the foreign-born control, foreign-born in-

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Fig 3. Feeding mixture in weeks 1 to 26 for the intervention group (A) and the control group (B).

tervention, and US-born intervention groups. In fact, identified themselves as Hispanic. Presumably, this
the mean breastfeeding intensity scores for the latter finding is related to demographic distributions in the
3 groups did not differ significantly from one an- study’s locale, ie, New York City. New York City
other. Therefore, our intervention was highly effec- experienced a 41% increase in the West Indian pop-
tive in raising the breastfeeding level of US-born ulation between 1990 and 2000, nearly all of whom
women to that of foreign-born women, whose scores identify themselves as black. West Indians repre-
did not differ according to treatment group. sented 25% of the black population of New York City
In contrast to the aforementioned results, race/ in 2000.42 Compared with the United States, West
ethnicity did not modify the effect of treatment Indian nations have considerably higher rates of any
group significantly. That is, the intervention was no and exclusive breastfeeding and longer duration of
more effective among one racial/ethnic group than breastfeeding.43–47 Presumably, in areas with high
another. Furthermore, in sharp contrast to recent concentrations of immigrant groups from countries
national studies,18,19 black women were 50% to 60% where breastfeeding is the standard, there is likely to
more likely to have a high intensity of breastfeeding, be both greater acceptance of breastfeeding and in-
compared with a reference group of women who formal support.

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TABLE 4. Unadjusted Breastfeeding Intensity Scores at 13 and 52 Weeks, According to Treatment
Group and Country of Origin
Intensity Score, Median (No.)
Intervention Control
US Born* Foreign Born* US Born* Foreign Born*
13 wk (range: 13–91)
All 61 (81) 51 (64) 88 (103) 53 (56)
Baseline parity of ⱖ1 49 (48) 43 (37) 87 (63) 51 (36)
52 wk (range: 52–364)
All 309 (81) 301 (64) 360 (103) 304 (56)
Baseline parity of ⱖ1 299 (48) 267 (37) 360 (63) 277 (36)
Median weekly intensity scores ranged from 1 (all breast milk) to 7 (all formula feeding). Higher scores
indicate greater formula feeding, whereas lower scores indicate greater breastfeeding. US born
denotes the US mainland and Hawaii. Given linguistic and cultural differences, participants born in
Puerto Rico were considered foreign born, although Puerto Rico is a US territory.
* The US-born control group differed significantly from all other groups at 13 and 52 weeks, both for
the entire sample and for the subsample with baseline parity of ⱖ1 (P ⬍ .05, analysis of variance,
Duncan’s multiple-comparisons test). No other groups differed significantly from one another.

In findings similar to ours, Celi et al40 found that breastfeeding intensity. These outcome measures,
foreign-born women were more likely to initiate which represent cumulative rather than prevalent
breastfeeding than US-born women (OR: 3.2; 95% CI: feeding patterns, contrast with how data on breast-
2.0 –5.2), in multivariate analyses controlling for feeding generally are collected and presented. Com-
race/ethnicity. In addition, they found no material pared with the intervention group, control subjects
difference in initiation rates among US-born white, had increased odds of low breastfeeding of 90% at 13
black, and Hispanic women.40 Those data and ours weeks and 150% at 52 weeks. Although intervention
differ from analyses of the National Survey of Family contacts were concentrated in the early postpartum
Growth, which found that black women were 60% period, cumulative data show how effects persisted
less likely to have ever breastfed than were nonblack over the long term.
women, even after controlling for country of origin. In our study, differences in breastfeeding out-
Foreign-born women were 75% more likely than US- comes cannot be attributed to differences in the birth
born women to have ever breastfed in that study.41 and immediate postpartum experiences, which were
The studies cited above were based on observa- nearly identical for the 2 groups. Essentially the same
tional data. They are unable to predict who would large proportions of women in the 2 groups had their
derive the most benefit from an intensive interven- infants at the centers’ affiliated hospital, thus reduc-
tion, such as the one tested in this study. Our find- ing the risk of bias associated with hospital practice.
ings with regard to country of origin and race/eth- In addition, this facilitated LC access to participants,
nicity are valuable for targeting future interventions. because we were notified about births at that hospi-
National data consistently place non-Hispanic black tal. Immediate postpartum experiences were similar,
women at greatest risk for not initiating or limiting in terms of women being asked if they wanted to
breastfeeding.18,19,41 We posit that race/ethnicity breastfeed in the delivery room and breastfeeding in
may matter less than cultural background in deter- the first 4 hours after birth.
mining who would benefit most from future inter- A particular strength of our study is the collection
ventions. of detailed weekly feeding data up to 52 weeks.
Our findings with regard to baseline feeding in- Surveys, particularly those based on large, popula-
tentions underscore the importance of prenatal coun- tion-based samples, tend to assess only partial or
seling to increase knowledge about the benefits of exclusive breastfeeding. Without a full assessment of
breastfeeding (and risks of not doing so) and to breastfeeding practices, it is difficult to tailor inter-
identify and to overcome perceived barriers to ventions. In addition, limited outcomes assessments
breastfeeding. Compared with women who intended (eg, at 6, 12, and 16 weeks) can obscure and/or
to breastfeed their new infants exclusively, women distort true differences. For instance, our finding that
who intended only formula feeding were 10 to 14 the intervention group reached the Healthy People
times more likely, depending on observation period 2000 goal of continued breastfeeding to 5 or 6 months
and parity, to have low breastfeeding intensity. Con- would have been obscured had we collected data
cerns about pain and breastfeeding in public and an only at week 26 and not week 20 and week 21 (⬃5
unsupportive work environment can be potential months). Conversely, reporting a significant differ-
barriers to breastfeeding, particularly among low- ence in ⱖ50% breast milk at week 26 (⬃4 months)
income women.48,49 Individualized counseling, such would have been a distortion, given the lack of sig-
as that provided by the study LCs, can help women nificance in intervening weeks 10 to 14 and from
strategize about how best to address these potential week 17 up to week 52.
barriers. Our intervention was innovative, in that it com-
Data on breastfeeding duration and amount were bined multiple skills-based and supportive compo-
used to derive both short-term (13 weeks, ie, 3 nents, with early prenatal education and support and
months) and long-term (52 weeks) measures of immediate hospital and home availability. The US

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ARTICLES 1421
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TABLE 5. Odds of Low Versus High Breastfeeding at 13 and 52 Weeks
Variable Values OR (95% CI)

TRIAL OFDownloaded
13 wk 52 wk

LACTATION
All (n ⫽ 304) Baseline Parity of ⱖ1 All (n ⫽ 304) Baseline Parity of ⱖ1
(n ⫽ 184) (n ⫽ 184)
Intent at baseline Undecided 3.04* (1.22–7.58) 2.52 (0.66–9.64) 3.02* (1.21–7.56) 3.30 (0.81–13.48)
Formula 10.51* (2.97–37.15) 14.20* (2.50–80.73) 10.05* (3.04–33.20) 11.08* (2.19–56.14)
Combined 1.57 (0.85–2.87) 1.21 (0.55–2.70) 2.22* (1.19–4.15) 2.36 (1.00–5.56)
Breast milk 1.00 1.00 1.00 1.00
Logarithm of age† Years 0.92* (0.88–0.96) 0.91* (0.86–0.98)
Age ⬍24 y 0.95 (0.90–1.01) 3.15* (1.83–5.42)
⬎24 y 1.00 1.00
Race/ethnicity Black 0.44* (0.24–0.79) 0.37* (0.20–0.67)
Other 1.75 (0.60–5.13) 1.40 (0.48–4.10)
Hispanic 1.00 1.00
Treatment group/country of origin‡ Control/US born 5.22* (2.43–11.22) 7.66* (2.75–21.36) 5.25* (2.44–11.29) 8.05* (2.84–22.78)
Control/foreign born 0.90 (0.40–2.04) 1.37 (0.42–4.48) 1.06 (0.47–2.40) 1.40 (0.43–4.56)
Intervention/US born 1.67 (0.78–3.53) 1.22 (0.41–3.67) 1.15 (0.54–2.45) 0.91 (0.30–2.74)

CONSULTANT INTERVENTION
Intervention/foreign born 1.00 1.00 1.00 1.00
Medicaid No 1.05 (0.61–1.82) 0.71 (0.41–1.23)
Yes 1.00 1.00
Breastfed before No 1.79 (0.79–4.04) 2.91* (1.24–6.83)
Yes NA 1.00 NA 1.00
Model r2 0.24 0.28 0.25 0.32
Treatment group§ Control 1.90* (1.13–3.20) 3.71* (1.81–7.59) 2.50* (1.48–4.21) 4.47* (2.13–9.36)
Intervention 1.00 1.00 1.00 1.00
Breastfeeding intensity scores were dichotomized at the median. ORs indicate the risk of low breastfeeding, compared with the reference category.
* P ⬍ .05.
† For ease of interpretation, we present the effect for age, although the model was analyzed with the logarithm of age.
‡ US born denotes the US mainland and Hawaii. Although Puerto Rico is a US territory, women born in Puerto Rico were classified as foreign born, given cultural and linguistic differences.
§ These treatment group ORs and 95% CIs were derived from an alternative logistic regression model that used the same set of significant covariates except that treatment group was used in place
of the treatment group-country of origin interaction terms. ORs and 95% CIs for covariates in the alternative logistic regression model were essentially unchanged from those shown.

from www.aappublications.org/news at Indonesia:AAP Sponsored on November 16, 2020


Preventive Services Task Force meta-analysis found duration and intensity in this hard-to-reach, socio-
that educational programs had the greatest effect of economically disadvantaged population.
any single intervention on both initiation (mean dif- In a prospective study, some loss to follow-up is
ference: 0.23%; 95% CI: 0.12– 0.34) and short-term inevitable. Given the nature of our population and
duration (mean difference: 0.39%; 95% CI: 0.27– 0.50). the length of planned follow-up monitoring (52
In-person and/or telephone support increased short- weeks), we view our retention rates as a relative
term duration (mean difference: 0.11%; 95% CI: 0.03– success. Among the 304 women in our outcomes
0.19) and long-term duration (mean difference: sample, infant feeding data were obtained for 91% at
0.08%; 95% CI: 0.02– 0.16). Notably, the number of 3 months, 83% at 6 months, 75% at 9 months, 65% at
subjects included in the meta-analysis of combined 11 months, and 56% at 12 months. Missing data
effects of education and support for initiation (n ⫽ implications were minimized by several factors.
170), short-term duration of up to 3 months (n ⫽ First, feeding patterns are most labile in the first 6
163), and long-term duration of 4 to 6 months (n ⫽ months, and feeding data were available for 83% of
168) was smaller than our outcomes sample of 304.28 participants through that time. Second, given the
Another strength of our intervention was the per- trend toward increased formula feeding over time,
sonalized continuity of care that our LCs provided our imputation of the treatment group’s median
across the prenatal and postnatal periods. Our LCs weekly value for missing weeks is statistically con-
reported that taking the time to develop a rapport servative. Third, the potential for bias was reduced
with each woman contributed to their effectiveness. by the fact that participants lost to follow-up moni-
Prenatal LC sessions lasted 1 to 2 hours, exceeding toring at 2, 3, 4, 6, 8, 10, and 12 months did not differ
the 15 to 30 minutes estimated at the study’s incep- from those retained at those months, with respect to
tion. This time investment during the prenatal period major covariates.
is credited with the women trusting and accepting This was a labor-intensive intervention. Accord-
LC support and advice in the postpartum period.25 ingly, we sought to develop a general estimate of the
Postnatally, women who received a home visit from average cost per woman for this level of intervention,
the LC had lower TOTAL13 scores (ie, greater breast- assuming that the LC was a health center employee
feeding intensity) than did those who did not, which and not a consultant. This estimate, which was based
suggests that home visits made an important contri- on an intention-to-treat model and included costs for
travel, supplies, and labor (wage, indirect, and fringe
bution to the intervention’s success. However, as
costs), in 2003 was $266 per woman throughout the
noted earlier, these unadjusted data must be inter-
prenatal and postnatal periods. Additional informa-
preted with caution. Although results are suggestive,
tion on the calculation of this estimate was reported
additional analyses beyond the scope of this report
elsewhere.35
are needed to understand more completely the ef-
Potential recall bias in maternal self-reports of
fects of various components of the intervention, con- breastfeeding might have resulted in nondiffer-
trolling for covariates such as prenatal feeding inten- ential misclassification or over-reporting of breast-
tions and parity. feeding. Nondifferential misclassification would
A caveat to our work, and a question for future bias results toward the null hypothesis. Over-report-
research, is what impact, if any, pumped milk and ing of breastfeeding, particularly in the intervention
breast pumps have on breastfeeding. As noted ear- group, might occur if women provided socially de-
lier, although study LCs generally discouraged sirable answers, particularly if they developed a
breast pump use unless the mother was separated strong relationship with the LC. Interestingly, in exit
from her infant, breast pumps were provided free of interviews conducted for this study, some control
charge to intervention group women under certain group women stated that the postpartum interviews
circumstances. We did not collect data on the source made them more conscious of how they fed their
of the infant’s breast milk. However, anecdotal data infant. One woman in the control group stated spe-
from women in both groups suggested strong inter- cifically that she kept breastfeeding to 3 or 4 months
est in the use of breast pumps as a means of avoiding because she knew the interviewer would ask.25 Un-
inconvenience or the embarrassment of nursing in der-reporting of breastfeeding is unlikely, given
public. Particularly for younger mothers (eg, ⬍18 similar feeding intentions at baseline. Mothers can
years of age), breast pump use might have contrib- reliably recall breastfeeding duration over many
uted to increased breastfeeding duration and inten- years,50,51 particularly for infants, with no difference
sity. in accuracy of recall according to educational level,
This trial was based on an intention-to-treat parity, or number of children.52 No published work
model. This model preserves the balance of random- validates maternal self-reports of varying levels of
ization, is statistically conservative (biases toward breastfeeding intensity. Population-based studies re-
the null hypothesis), and simulates nonresearch sit- port either duration according to limited intensity
uations. Reflecting the vulnerable population served (exclusive versus nonexclusive) or duration (without
by the health centers, nearly 20% of the intervention any intensity) and do not validate maternal self-
outcomes sample did not receive the intervention, reports.
36% did not have a prenatal contact, and 37% did not Related to this, some women found the Index of
have a postnatal contact. Less than one half (47%) Breastfeeding Status, which asks for estimates of
had both prenatal and postnatal contacts. However, breast milk given to their infant, to be confusing.
we still found significant differences in breastfeeding Research staff members first asked whether the in-

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1423
fant received more breast milk than formula and counselor resulted in lower but not statistically sig-
then tried to quantify the amount by asking how nificant differences in duration. 56 In a similar pop-
many feedings of 10 this would correspond to for a ulation, a more intensive intervention of prenatal
given week. One alternative would be to ask how home visits (n ⫽ 3), daily hospital visits, and post-
times per day or week, in the past 7 days, the infant partum home visits (n ⫽ 9) resulted in significantly
was fed each item from a list (eg, breast milk, for- higher exclusive breastfeeding at 3 months (20.6% vs
mula, 100% juice, sweet drinks, or infant cereal). This 1.4% of controls).57 Thus considerable effort will be
approach, used in the Food and Drug Administra- required to reach the proposed Healthy People 2010
tion 1993–1994 Infant Feeding Practices Study53 and goal of 60% exclusive breastfeeding at 3 months.
its successor, which is currently underway in the In the future, interventions must target exclus-
field, may provide a better estimate of the proportion ivity, beginning in the prenatal period. Breastfeeding
of all intake from breast milk. The disadvantage is intensity ratios (breast milk/all liquid nutrition)
that this level of detail is likely to be unreliable over over the first 6 months are associated strongly with
longer recall periods, such as those used in our breastfeeding duration.58 In other work, prenatal in-
study. tent to combine breast milk and formula resulted in
A limitation of our intervention was that study shorter planned and actual duration,59 whereas in
LCs functioned as outside research consultants. our study a prenatal intention other than exclusive
Therefore, it was incumbent on them to schedule the breastfeeding was associated significantly with low
prenatal intervention sessions at the clinic when breastfeeding intensity at 3 and 12 months. Further-
women were there for prenatal visits. With this vul- more, protective effects are dose-responsive.12,15,60,61
nerable sample, for which there is an estimated Minimal breastfeeding may not be protective.12 A
missed appointment rate of 40% for prenatal care meta-analysis of hospitalizations for treatment of
visits, scheduling these sessions was difficult. Fur- lower respiratory tract disease found a summary
thermore, the LCs did not have a routine presence or relative risk of 0.28 (95% CI: 0.14 – 0.54) conferred
dedicated office space and were not part of the wom- by exclusive breastfeeding for ⬎4 months.62 There
en’s health care team. This impeded our ability to may be a threshold effect for certain outcomes, be-
make prenatal contacts and might have diminished cause 3 vs 6 months of exclusive breastfeeding were
the potency of the intervention. equivalent in several measures (not hospitalization)
Another limitation of the intervention was the low in a large cohort.63 However, the most recent state-
postpartum hospital contact rate (25%). Some ments from the American Academy of Pediatrics
women, when telephoned at the hospital, declined a and the World Health Organization define the opti-
LC visit at that time but were later seen at home mal duration of exclusive breastfeeding as 6
(home contact rate: 49%). This is consistent with our months.1,14
observation that some women preferred to initiate Goals and interventions targeted toward sustained
breastfeeding in the privacy of their homes, rather exclusive breastfeeding are more relevant than those
than in the busy hospital setting. Other women de- focused solely on any breastfeeding. The primary
clined a visit altogether, either because they were message of the National Breastfeeding Awareness
formula feeding exclusively or because they stated Campaign, a multimedia effort launched in 2004, is
that they did not need LC assistance. Delays in that exclusive breastfeeding for 6 months reduces an
timely notification of the birth and LC scheduling infant’s risk of ear infections, gastrointestinal ill-
problems also contributed to this low hospital con- nesses, and respiratory illnesses and may prevent
tact rate. obesity.64 Our findings support the focus of and need
A trial similar to ours, a randomized, nonblinded, for such a nationwide effort. In addition, individual-
clinical, controlled trial of prenatal and postnatal LC ized continuity of care provided by interventions
support (including the hospital) among low-income such as ours are indicated to achieve the pending
women, found significant differences in breastfeed- Healthy People 2010 goals of 25% exclusive breast-
ing duration until 2 months of age (37% for the feeding at 3 and 6 months, as proposed at the last
intervention group, compared with 9% for the con- interim review (Rosie Li, MD, PhD, written commu-
trol group).54 In contrast, treatment group differ- nication, March 4, 2005).
ences persisted up to 20 weeks in our study (53% for Our study LCs had the proper skills and profes-
the intervention group, compared with 39% for the sional orientation to deliver the intervention. How-
control group). Furthermore, the potential for bias ever, they were hampered by their consultant status.
was significant in that trial, because the study LC A routine clinic and hospital presence (ie, “round-
assessed breastfeeding outcomes. ing”) would most likely increase prenatal and post-
Recently published findings from randomized tri- natal contact rates, particularly for hard-to-reach
als of combined prenatal and postnatal interventions populations. The intervention’s effectiveness would
show differences in outcomes according to the inten- likely increase with prenatal care provider encour-
sity of the intervention. A randomized, controlled agement; mothers receiving such encouragement are
trial of prenatal provider counseling, combined with less likely to discontinue feeding ⱖ50% breast milk
(primarily) phone availability of an LC postpartum, at 3 months.65 We think that routinely offered, indi-
had no effect on any breastfeeding or exclusive vidualized, breastfeeding education and support,
breastfeeding (Netherlands).55 In a low-income US with clinician encouragement, in the prenatal period
Latina population, prenatal (n ⫽ 1), daily perinatal, and continued support throughout the postpartum
and postpartum home visits (n ⫽ 3) from a peer period up to 12 months will result in a higher inten-

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ACKNOWLEDGMENTS 27. Graffy J, Taylor J, Williams A, Eldridge S. Randomised controlled trial
of support from volunteer counselors for mothers considering breast
This study was supported by grants from the United States
feeding. BMJ. 2004;328:26
Department of Agriculture, the Maternal and Child Health Bu-
28. Guise JM, Palda V, Westhoff C, et al. The effectiveness of primary-care
reau, and the Agency for Healthcare Quality and Research.
based interventions to promote breastfeeding: systematic evidence re-
view and meta-analysis for the US Preventive Services Task Force. Ann
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Keeping the United States in the Race

“What if we were really having a national discussion about what is most


important to the country today and on the minds of most parents? I have no doubt
that it would be a loud, noisy dinner-table conversation about why so many U.S.
manufacturers are moving abroad—not just to find lower wages, but to find
smarter workers, better infrastructure and cheaper health care. It would be about
why in Germany, 36 percent of undergrads receive degrees in science and engi-
neering; in China, 59 percent; in Japan, 66 percent; and in America, only 32 percent.
It would be about why Japanese on bullet trains can get access to the Internet with
cellphones, and Americans get their cell phone service interrupted five minutes
from home. It would be about why U.S. 12th graders recently performed below the
international average for 21 countries in math and science, and it would be about
why, in recent years, U.S. industry appears to have spent more on lawsuits than on
R&D. Yes, we’d be talking about why the world is racing us to the top, not the
bottom, and why we are quietly falling behind.”

Friedman TL. New York Times. October 14, 2005

Noted by JFL, MD

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Randomized, Controlled Trial of a Prenatal and Postnatal Lactation Consultant
Intervention on Duration and Intensity of Breastfeeding up to 12 Months
Karen A. Bonuck, Michelle Trombley, Katherine Freeman and Diane McKee
Pediatrics 2005;116;1413
DOI: 10.1542/peds.2005-0435

Updated Information & including high resolution figures, can be found at:
Services http://pediatrics.aappublications.org/content/116/6/1413
References This article cites 42 articles, 15 of which you can access for free at:
http://pediatrics.aappublications.org/content/116/6/1413#BIBL
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Randomized, Controlled Trial of a Prenatal and Postnatal Lactation Consultant
Intervention on Duration and Intensity of Breastfeeding up to 12 Months
Karen A. Bonuck, Michelle Trombley, Katherine Freeman and Diane McKee
Pediatrics 2005;116;1413
DOI: 10.1542/peds.2005-0435

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/116/6/1413

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since 1948. Pediatrics is owned, published, and trademarked by
the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 2005
by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

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