Does Formula Advertising During Pregnancy Affect Breastfeeding

Initiation or Duration?

Cynthia R Howard MD, MPHAssociate Professor of Pediatrics

The University of Rochester School of Medicine and Dentistry

Pediatric Director of the Mother Baby Unit

The Rochester General Hospital

Antenatal Formula Advertising and the Effect on BreastfeedingAntenatal Formula Advertising and the Effect on Breastfeeding

Funded by a research grant from the Bureau of Funded by a research grant from the Bureau of Maternal and Child Health (MCJ 360752)Maternal and Child Health (MCJ 360752)

Conducted between 10/94 and 12/97Conducted between 10/94 and 12/97 Co investigatorsCo investigators

Fred M Howard MD, FAACOGFred M Howard MD, FAACOG Ruth Lawrence MD, FAAPRuth Lawrence MD, FAAP Elena Andresen, Ph.D.Elena Andresen, Ph.D. Michael Weitzman MD, FAAPMichael Weitzman MD, FAAP

Prenatal Formula AdvertisingPrenatal Formula Advertising

BackgroundBackground Prevalence DataPrevalence Data

Survey of expectant womenSurvey of expectant women Survey of Obstetrician GynecologistsSurvey of Obstetrician Gynecologists

Results of the RCTResults of the RCT

"A pair of substantial mammary glands has the "A pair of substantial mammary glands has the advantage over the two hemispheres of the most advantage over the two hemispheres of the most learned professor's brain in the art of learned professor's brain in the art of compounding a nutritious fluid for infants"compounding a nutritious fluid for infants"

Oliver Wendell HolmesOliver Wendell Holmes

Breast or Bottle

Healthy Children Goals

2010 Goals2010 Goals Initiation 75%Initiation 75% Duration to 5-6 months 50%; Duration to 5-6 months 50%;

12 months 25%12 months 25% 1998 Northeastern US1998 Northeastern US

Initiation 64%Initiation 64% Duration to 6 months 29%; 12 Duration to 6 months 29%; 12

months 16%months 16% Rochester data Rochester data

~20-30% of women breastfeed ~20-30% of women breastfeed for <= 1 monthfor <= 1 month

0%

25%

50%

75%

100%

0 6 12

20101998

Months

BackgroundBackground

Obstetricians have begun distributing formula Obstetricians have begun distributing formula company produced infant feeding education company produced infant feeding education materials and formula samples to their patients materials and formula samples to their patients during prenatal careduring prenatal care

Is this practice harmful?Is this practice harmful?

No studies of the effects of formula advertising to No studies of the effects of formula advertising to pregnant women on breastfeeding initiation or pregnant women on breastfeeding initiation or durationduration

Several existing studies of the effects of formula Several existing studies of the effects of formula samples and advertising on breastfeeding durationsamples and advertising on breastfeeding duration

Formula Discharge PacksFormula Discharge Packs

TheThe postpartumpostpartum distribution of distribution of commercialcommercial as as compared to compared to non-commercialnon-commercial discharge packs discharge packs shortens breastfeeding durationshortens breastfeeding duration RP of termination at 1 month 1.4 (1.0;2.1) RP of termination at 1 month 1.4 (1.0;2.1) RP of less than full breastfeeding at 1 month RP of less than full breastfeeding at 1 month

1.1(1.0;1.3) 1.1(1.0;1.3) RP of termination at 4 months 1.2 (1.0;1.5)RP of termination at 4 months 1.2 (1.0;1.5)

R. Perez-Escamilla et al. Infant feeding policies in maternity wards and their effect on breast-feeding success: An analytical overview. American Journal of Public Health 84 (1):89-97, 1994.

Prenatal Education About Infant FeedingPrenatal Education About Infant Feeding

Survey of 136 consecutive women interviewed Survey of 136 consecutive women interviewed during their peripartum hospitalizationduring their peripartum hospitalization 82% received infant feeding educational materials

during prenatal care 64% published by a formula company

64% reported the receipt of a free formula offer 90% of these offers were obtained from the woman’s

prenatal care provider

Howard, Howard, Weitzman Birth 21:1, March 1994

Survey of Obstetrician GynecologistSurvey of Obstetrician Gynecologist

Obstetricians in Monroe County New YorkObstetricians in Monroe County New York 78% response rate to mailed survey78% response rate to mailed survey 104 practicing obstetricians104 practicing obstetricians

Formula company produced infant feeding Formula company produced infant feeding literature (41%), pregnancy literature (57%) and literature (41%), pregnancy literature (57%) and free formula offers (61%) were commonly usedfree formula offers (61%) were commonly used

C. R. Howard, S. J. Schaffer, and R. A. Lawrence. Attitudes, practices, and recommendations by obstetricians about infant feeding. Birth 24 (4):240-246, 1997.

ObjectivesObjectives

To compare the effect of formula company-produced To compare the effect of formula company-produced materials about infant feeding to breastfeeding promotion materials about infant feeding to breastfeeding promotion materials without formula advertising on breastfeedingmaterials without formula advertising on breastfeeding InitiationInitiation DurationDuration Early termination (in- hospital and <= 2 weeks)Early termination (in- hospital and <= 2 weeks) Exclusive, full , and overall durationExclusive, full , and overall duration Attainment of breastfeeding goalsAttainment of breastfeeding goals

Examine the effect on ‘vulnerable’ groups of womenExamine the effect on ‘vulnerable’ groups of women

C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

Study Design/MethodsStudy Design/Methods

Randomized, investigator blinded clinical trialRandomized, investigator blinded clinical trial 547 women randomized at first prenatal visit to receive 547 women randomized at first prenatal visit to receive

infant formula company produced infant formula company produced (commercial)(commercial) or or specially designed specially designed (research)(research) infant feeding educational infant feeding educational materialsmaterials

Infant feeding method observed at deliveryInfant feeding method observed at delivery Prospective telephone follow-up (2, 6, 12 and 24 weeks) Prospective telephone follow-up (2, 6, 12 and 24 weeks)

of the mothers who chose to breastfeed their infantsof the mothers who chose to breastfeed their infants

C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

Study Design Study Design

Commercial MaterialsInfant Formula Co. Produced

277 Women

Research MaterialsBreastfeeding Promotion Materials

270 Women

Pregnancy LossesTransfer of Care; Twins

42 Commercial61 Research

Missed in Hospital4 Commercial

1 Research

Formula Feeding133 Women

72 Commercial61 Research

Missed in Hospital2 Research

Breastfeeding311 Women

163 Commercial148 Research

Hospital Interview444 Women

235 Commercial209 Research

Randomization547 Women

First Prenatal Visit

Study Design: Breastfeeding WomenStudy Design: Breastfeeding Women

2 Lost to Follow-up

4 Lost to Follow-up

2 Lost to Follow-up

3 Lost to Follow-up

Telephone Follow-up24 weeks

Telephone Follow-up12 weeks

Telephone Follow-up6 weeks

Telephone Follow-up2 weeks

Breastfeeding at Discharge265 Women

134 Commercial131 Research

Termination in Hospital14 Women

12 Commercial2 Research

Refusal to Participate15 Women

9 Commercial6 Research

Ineligible for Follow-up15 Women

8 Commercial7 Research

Participant Follow-upParticipant Follow-up

547 Randomized547 Randomized 71 lost due to miscarriage, 26 relocation, 3 71 lost due to miscarriage, 26 relocation, 3

randomization non-pregnant, 3 multiple gestationrandomization non-pregnant, 3 multiple gestation 444 Delivered 444 Delivered 311 Breastfeeding Women 311 Breastfeeding Women

2 missed, 15 ineligible, 15 refused f/u, 11 lost to f/u 2 missed, 15 ineligible, 15 refused f/u, 11 lost to f/u before 24 weeks postpartumbefore 24 weeks postpartum

Total Losses 26.7% (146 out of 547)Total Losses 26.7% (146 out of 547)

C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

Selected Characteristics of Study Participants (N=444)Selected Characteristics of Study Participants (N=444)

Factor Commercial Research p value White 95% 92% .36

Married 86% 82% .33

Insured 99% 97% .31

Primiparous 44% 45% .92

C/Section 24% 17% .10

Prev BF 39% 41% .62

Selected Characteristics of Study Participants (N=444)Selected Characteristics of Study Participants (N=444)

Factor Commercial Research p value Plan Work 60% 59% .75< 12 yrs ed 36% 33% .55

Age 29.9 29.9 .98Infant GA 39.6 39.6 .59Infant BW 3510 3519 .86

AnalysesAnalyses

The effect of the The effect of the CommercialCommercial (C) Vs. (C) Vs. ResearchResearch (R) pack (R) pack was tested on the relevant feeding outcomes.was tested on the relevant feeding outcomes.

Continuous outcomes (e.g. breastfeeding duration)Continuous outcomes (e.g. breastfeeding duration) Kaplan Meier and Cox proportional hazards analysesKaplan Meier and Cox proportional hazards analyses

Discrete Outcomes (e.g. initiation, in-hospital Discrete Outcomes (e.g. initiation, in-hospital termination)termination)

Chi square and logistic regression analysesChi square and logistic regression analyses

p values <=.05 considered statistically significantp values <=.05 considered statistically significant

Breastfeeding Initiation (n=444)

Formula Breast

Commercial 72 (31%) 163 (69%)

Research 61 (29%) 148 (71%)

RR (95% CI) 0.93 (0.61-1.43) p=.82

Termination of Breastfeeding Prior to Hospital Discharge (n=311)

Terminated Continued

Commercial 12 (7%) 151 (92%)

Research 2 (1%) 146 (99%)

RR (95% CI) 5.80 (1.25-54.01) p=0.02*

* Fisher’s exact two tailed test* Fisher’s exact two tailed test

Termination of Breastfeeding Prior to Hospital Discharge

SUBJECTS MODEL COVARIATES RR/OR (95% CI) P VALUE

IN MODEL

311 Unadjusted 5.80 1.25-54.01 .02

Adjusted Commercial Pack 10.28 1.30-81.18 .03

Plan to Work 1.06 0.80-1.41

Previously Breastfed 1.48 0.38-5.75

Not Married 1.37 0.20-9.15

Maternal Age 0.91 0.78-1.07

SES 0.99 0.96-1.02

Termination of Breastfeeding at or Before Two Weeks Postpartum (n=294)

Terminated Continued

Commercial 37 (24%) 118 (76%)

Research 21 (15%) 118 (85%)

RR (95% CI) 1.58 (0.97, 2.56) p=0.06Adjusted OR 1.91 (1.02, 3.55) p=0.04

Adjusted for age, return to work, breastfeeding experience, MS and SESAdjusted for age, return to work, breastfeeding experience, MS and SES

In-Hospital TerminationIn-Hospital Termination

Rate in Research group (control)Rate in Research group (control) 2/148 = 1.4%2/148 = 1.4%

Rate in Commercial group (treatment)Rate in Commercial group (treatment) 12/163 = 7.4%12/163 = 7.4%

Absolute Risk Increase = Tx - Control Absolute Risk Increase = Tx - Control 7.4% - 1.4%= 6.0%7.4% - 1.4%= 6.0%

In-Hospital TerminationIn-Hospital Termination

Number Needed to HarmNumber Needed to Harm 1.0/.06 = 16.71.0/.06 = 16.7

For every 17 women exposed to commercial For every 17 women exposed to commercial materials prenatally, 1 will quit breastfeeding materials prenatally, 1 will quit breastfeeding before hospital discharge due to the exposurebefore hospital discharge due to the exposure

Breastfeeding DurationBreastfeeding Duration

InitiationInitiationDay 0Day 0

1st liquid1st liquidor solid foodor solid foodDay 30Day 30

Daily Daily liquid or liquid or foodfoodDay 60Day 60

TerminateTerminateDay 90Day 90

ExclusiveExclusive30 days30 days FullFull

60 days60 daysOverallOverall90 days90 days

Mean Duration of Breastfeeding (n=294)Mean Duration of Breastfeeding (n=294)

Breastfeeding DurationDays (95% CI)

Group Exclusive Full Overall

Commercial 33 (27, 40) 49 (41, 57) 107 (95, 119)

Research 40 (32, 47) 59 (50, 69) 118 (106, 130)

p>.05p>.05

Vulnerable Women: Subgroup AnalysesVulnerable Women: Subgroup Analyses

Low educational attainment (<= 12 years)Low educational attainment (<= 12 years) Primiparous womenPrimiparous women Delivery by C-sectionDelivery by C-section Shorter or non-specific goals for breastfeedingShorter or non-specific goals for breastfeeding

less than 12 weeks or no specific goal (43% of less than 12 weeks or no specific goal (43% of participants)participants)

Overall Breastfeeding Duration According to Breastfeeding GoalOverall Breastfeeding Duration According to Breastfeeding Goal

0%10%20%30%40%50%60%70%80%90%

100%

0 1 2 3 4 5 6

C/high

R/high

C/low

R/low

MonthsMonths

Full Breastfeeding Duration According to Breastfeeding GoalFull Breastfeeding Duration According to Breastfeeding Goal

0%10%20%30%40%50%60%70%80%90%

100%

0 1 2 3 4 5 6

C/high

R/high

C/low

R/low

MonthsMonths

Exclusive Breastfeeding DurationAccording to Breastfeeding GoalExclusive Breastfeeding DurationAccording to Breastfeeding Goal

0%10%20%30%40%50%60%70%80%90%

100%

0 1 2 3 4 5 6

C/high

R/high

C/low

R/low

MonthsMonths

Mean Duration of Breastfeeding Among Women with Shorter Goals (n=128)Mean Duration of Breastfeeding Among Women with Shorter Goals (n=128)

Breastfeeding DurationDays (95% CI)

ShorterGoals

Exclusive Full Overall

Commercial 17 (11, 24) 24 (16, 32) 57 (42, 73)

Research 28 (19, 36) 44 (31, 56) 92 (74, 110)

All outcomes p<.05All outcomes p<.05

Attainment of Breastfeeding Goal(n=225)

Failed Attained

Commercial 52 (43%) 69 (57%)

Research 39 (37.5%) 65 (62.5%)

RR (95% CI) 0.80 (0.47,1.36) p=NS

LimitationsLimitations

Study populationStudy population InterventionIntervention

Breastfeeding supportive environmentBreastfeeding supportive environment hospital settinghospital setting follow-up follow-up

Formula advertising from other sourcesFormula advertising from other sources

ConclusionsConclusions

Obstetrical distribution of formula company Obstetrical distribution of formula company promotional materials does not significantly affect promotional materials does not significantly affect maternal choice of infant feeding methodmaternal choice of infant feeding method

The risk that women will terminate breastfeeding in the The risk that women will terminate breastfeeding in the early postpartum time period, however, is substantially early postpartum time period, however, is substantially increased.increased.

Women with uncertain personal breastfeeding goals or Women with uncertain personal breastfeeding goals or goals of less than 12 weeks are at risk for significantly goals of less than 12 weeks are at risk for significantly shortened breastfeeding durationshortened breastfeeding duration

C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

ConclusionsConclusions

Educational materials about infant feeding should Educational materials about infant feeding should unequivocally support breastfeeding as optimal unequivocally support breastfeeding as optimal nutrition for infants; formula promotion products should nutrition for infants; formula promotion products should be eliminated from prenatal settingsbe eliminated from prenatal settings

C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

ThanksThanks

Bureau of Maternal and Child Health Participating Obstetric Practices

Panorama Obstetrics and GynecologyPanorama Obstetrics and Gynecology Westridge Obstetrics and GynecologyWestridge Obstetrics and Gynecology Faculty Practice of Rochester General HospitalFaculty Practice of Rochester General Hospital

The Departments of Obstetrics & Gynecology and Pediatrics at Rochester General Hospital