A randomized breast-feeding promotion intervention did not reduce child obesity in Belarus.

The evidence that breast-feeding protects against obesity is based on observational studies, with potential for confounding and selection bias. This article summarizes a previously published study in which we assessed whether an intervention designed to promote exclusive and prolonged breast-feeding affects children's height, weight, adiposity, and blood pressure (BP) at age 6.5 y. The Promotion of Breastfeeding Intervention Trial (PROBIT) is a cluster-randomized trial of a breast-feeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative. A total of 17,046 healthy breast-fed infants were enrolled from 31 Belarussian maternity hospitals and affiliated clinics, of whom 13,889 (81.5%) were followed up at 6.5 y with duplicate measurements of height, weight, waist circumference, triceps and subscapular skinfold thicknesses, systolic and diastolic BP. Analysis was based on intention to treat, with statistical adjustment for clustering within hospitals/clinics to permit inferences at the individual level. The experimental intervention led to a large increase in exclusive breast-feeding at 3 mo (43.3% vs. 6.4%, P < 0.001) and a significantly higher prevalence of any breast-feeding throughout infancy. No significant intervention effects were observed on height, BMI, adiposity measures, or BP. The breast-feeding promotion intervention resulted in substantial increases in the duration and exclusivity of breast-feeding yet did not reduce measures of adiposity at age 6.5 y. Previous reports of protective effects against obesity may reflect uncontrolled bias caused by confounding and selection.

Breastfeeding and child cognitive development: new evidence from a large randomized trial.

CONTEXT: The evidence that breastfeeding improves cognitive development is based almost entirely on observational studies and is thus prone to confounding by subtle behavioral differences in the breastfeeding mother's behavior or her interaction with the infant. OBJECTIVE: To assess whether prolonged and exclusive breastfeeding improves children's cognitive ability at age 6.5 years. DESIGN: Cluster-randomized trial, with enrollment from June 17, 1996, to December 31, 1997, and follow-up from December 21, 2002, to April 27, 2005. SETTING: Thirty-one Belarussian maternity hospitals and their affiliated polyclinics. PARTICIPANTS: A total of 17,046 healthy breastfeeding infants were enrolled, of whom 13,889 (81.5%) were followed up at age 6.5 years. INTERVENTION: Breastfeeding promotion intervention modeled on the Baby-Friendly Hospital Initiative by the World Health Organization and UNICEF. MAIN OUTCOME MEASURES: Subtest and IQ scores on the Wechsler Abbreviated Scales of Intelligence, and teacher evaluations of academic performance in reading, writing, mathematics, and other subjects. RESULTS: The experimental intervention led to a large increase in exclusive breastfeeding at age 3 months (43.3% for the experimental group vs 6.4% for the control group; P < .001) and a significantly higher prevalence of any breastfeeding at all ages up to and including 12 months. The experimental group had higher means on all of the Wechsler Abbreviated Scales of Intelligence measures, with cluster-adjusted mean differences (95% confidence intervals) of +7.5 (+0.8 to +14.3) for verbal IQ, +2.9 (-3.3 to +9.1) for performance IQ, and +5.9 (-1.0 to +12.8) for full-scale IQ. Teachers' academic ratings were significantly higher in the experimental group for both reading and writing. CONCLUSION: These results, based on the largest randomized trial ever conducted in the area of human lactation, provide strong evidence that prolonged and exclusive breastfeeding improves children's cognitive development. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN37687716.

Effects of prolonged and exclusive breastfeeding on child behavior and maternal adjustment: evidence from a large, randomized trial.

OBJECTIVE: The objective of this study was to assess the long-term effects of breastfeeding on child behavior and maternal adjustment. METHODS: We followed up children who were in the Promotion of Breastfeeding Intervention Trial, a cluster-randomized trial of a breastfeeding promotion intervention based on the World Health Organization/United Nations Children's Fund Baby-Friendly Hospital Initiative. A total of 17,046 healthy, breastfeeding mother-infant pairs were enrolled from 31 Belarussian maternity hospitals and affiliated polyclinics; 13,889 (81.5%) were followed up at 6.5 years. Mothers and teachers completed the Strengths and Difficulties Questionnaire and supplemental questions bearing on internalizing and externalizing behavioral problems. Mothers also responded to questions concerning their relationships to their partner and child and their breastfeeding of subsequently born children. RESULTS: The experimental intervention led to a large increase in exclusive breastfeeding at 3 months (43.3% vs 6.4%) and a significantly higher prevalence of any breastfeeding at all ages up to and including 12 months. No significant treatment effects were observed on either the mother or the teacher Strengths and Difficulties Questionnaire ratings of total difficulties, emotional symptoms, conduct problems, hyperactivity, peer problems, or prosocial behavior or on the supplemental behavioral questions. We found no evidence of treatment effects on the parent's marriage or on the mother's satisfaction with her relationships with her partner or child, but the experimental intervention significantly increased the duration of any breastfeeding, and mothers in the experimental group were nearly twice as likely to breastfeed exclusively the next-born child for at least 3 months. CONCLUSIONS: On the basis of the largest randomized trial ever conducted in the area of human lactation, we found no evidence of risks or benefits of prolonged and exclusive breastfeeding for child and maternal behavior. Breastfeeding promotion does, however, favorably affect breastfeeding of the subsequent child.

Effects of prolonged and exclusive breastfeeding on child height, weight, adiposity, and blood pressure at age 6.5 y: evidence from a large randomized trial.

BACKGROUND: The evidence that breastfeeding protects against obesity and a variety of chronic diseases comes almost entirely from observational studies, which have a potential for bias due to confounding, selection bias, and selective publication. OBJECTIVE: We assessed whether an intervention designed to promote exclusive and prolonged breastfeeding affects children's height, weight, adiposity, and blood pressure at age 6.5 y. DESIGN: The Promotion of Breastfeeding Intervention Trial (PROBIT) is a cluster-randomized trial of a breastfeeding promotion intervention based on the WHO/UNICEF Baby-Friendly Hospital Initiative. A total of 17,046 healthy breastfed infants were enrolled from 31 Belarussian maternity hospitals and their affiliated clinics; of those infants, 13,889 (81.5%) were followed up at 6.5 y with duplicate measurements of anthropometric variables and blood pressure. Analysis was based on intention to treat, with statistical adjustment for clustering within hospitals or clinics to permit inferences at the individual level. RESULTS: The experimental intervention led to a much greater prevalence of exclusive breastfeeding at 3 mo in the experimental than in the control group (43.3% and 6.4%, respectively; P < 0.001) and a higher prevalence of any breastfeeding throughout infancy. No significant intervention effects were observed on height, body mass index, waist or hip circumference, triceps or subscapular skinfold thickness, or systolic or diastolic blood pressure. CONCLUSIONS: The breastfeeding promotion intervention resulted in substantial increases in the duration and exclusivity of breastfeeding, yet it did not reduce the measures of adiposity, increase stature, or reduce blood pressure at age 6.5 y in the experimental group. Previously reported beneficial effects on these outcomes may be the result of uncontrolled confounding and selection bias.

Effect of prolonged and exclusive breast feeding on risk of allergy and asthma: cluster randomised trial.

OBJECTIVE: To assess whether exclusive and prolonged breast feeding reduces the risk of childhood asthma and allergy by age 6.5 years. DESIGN: Cluster randomised trial. SETTING: 31 Belarussian maternity hospitals and their affiliated polyclinics. PARTICIPANTS: A total of 17,046 mother-infant pairs were enrolled, of whom 13,889 (81.5%) were followed up at age 6.5 years. INTERVENTION: Breastfeeding promotion intervention modelled on the WHO/UNICEF baby friendly hospital initiative. MAIN OUTCOME MEASURES: International study of asthma and allergies in childhood (ISAAC) questionnaire and skin prick tests of five inhalant antigens. RESULTS: The experimental intervention led to a large increase in exclusive breast feeding at 3 months (44.3% v 6.4%; P<0.001) and a significantly higher prevalence of any breast feeding at all ages up to and including 12 months. The experimental group had no reduction in risks of allergic symptoms and diagnoses or positive skin prick tests. In fact, after exclusion of six sites (three experimental and three control) with suspiciously high rates of positive skin prick tests, risks were significantly increased in the experimental group for four of the five antigens. CONCLUSIONS: These results do not support a protective effect of prolonged and exclusive breast feeding on asthma or allergy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37687716 [controlled-trials.com].

Feeding effects on growth during infancy.

OBJECTIVE: To examine the effects of formula, other milks, other liquids, cereals, and other solid foods on growth during infancy. STUDY DESIGN: Observational cohort study nested within a large (n=17,046), cluster-randomized trial. We compared growth [weight-for-age, length-for-age, and weight-for-length z scores (WAZ, LAZ, WLZ) and head circumference (HC)] during the intervals 1 to 3, 3 to 6, 6 to 9, and 9 to 12 months, using hierarchical multivariate regression to control for size at the beginning of each interval, maternal education, geographic region, and urban versus rural location. RESULTS: Mixed BF and formula/other milk were associated with significantly higher (versus breast milk only) LAZ at 1 to 3 months (+0.038 and +0.047, respectively). In the 3- to 6-month interval, mixed BF and formula/other milk led to significantly higher WAZ (+0.125 and +0.139) and LAZ (+0.081 and +0.075), whereas cereal intake was associated with large and highly significant reductions in both measures (-0.293 and -0.240) and in HC (-0.291 cm). Mixed BF and formula/other milk continued to have positive albeit smaller associations with WAZ and LAZ in the 6- to 9-month and 9- to 12-month intervals. CONCLUSIONS: Our results confirm the growth-accelerating effects of formula and other milks (versus breast milk) on weight and length gain throughout infancy, with a dose-response gradient and largest associations observed at 3 to 6 months.

Infant growth and health outcomes associated with 3 compared with 6 mo of exclusive breastfeeding.

BACKGROUND: Opinions and recommendations about the optimal duration of exclusive breastfeeding have been strongly divided, but few published studies have provided direct evidence on the relative risks and benefits of different breastfeeding durations in recipient infants. OBJECTIVE: We examined the effects on infant growth and health of 3 compared with 6 mo of exclusive breastfeeding. DESIGN: We conducted an observational cohort study nested within a large randomized trial in Belarus by comparing 2862 infants exclusively breastfed for 3 mo (with continued mixed breastfeeding through >/= 6 mo) with 621 infants who were exclusively breastfed for >/= 6 mo. Regression to the mean, within-cluster correlation, and cluster- and individual-level confounding variables were accounted for by using multilevel regression analyses. RESULTS: From 3 to 6 mo, weight gain was slightly greater in the 3-mo group [difference: 29 g/mo (95% CI: 13, 45 g/mo)], as was length gain [difference: 1.1 mm (0.5, 1.6 mm)], but the 6-mo group had a faster length gain from 9 to 12 mo [difference: 0.9 mm/mo (0.3, 1.5 mm/mo)] and a larger head circumference at 12 mo [difference: 0.19 cm (0.07, 0.31 cm)]. A significant reduction in the incidence density of gastrointestinal infection was observed during the period from 3 to 6 mo in the 6-mo group [adjusted incidence density ratio: 0.35 (0.13, 0.96)], but no significant differences in risk of respiratory infectious outcomes or atopic eczema were apparent. CONCLUSIONS: Exclusive breastfeeding for 6 mo is associated with a lower risk of gastrointestinal infection and no demonstrable adverse health effects in the first year of life.

Breastfeeding and infant growth: biology or bias?

BACKGROUND: Available evidence suggests that prolonged and exclusive breastfeeding is associated with lower infant weight and length by 6 to 12 months of age. This evidence, however, is based on observational studies, which are unable to separate the effects of feeding mode per se from selection bias, reverse causality, and the confounding effects of maternal attitudinal factors. DESIGN/METHODS: A cluster-randomized trial in the Republic of Belarus of a breastfeeding promotion intervention modeled on the World Health Organization (WHO)/UNICEF Baby-Friendly Hospital Initiative versus control (then current) infant feeding practices. Healthy, full-term, singleton breastfed infants (n = 17 046) weighing > or =2500 g were enrolled soon after birth and followed up at 1, 2, 3, 6, 9, and 12 months old for measurements of weight, length, and head circumference. Data were analyzed according to intention-to-treat, while accounting for within-cluster correlation. To assess the potential for bias in observational studies of breastfeeding, we also analyzed our data as if we had conducted an observational study by ignoring treatment, combining the 2 randomized groups, and comparing 1378 infants weaned in the first month and those breastfed for the full 12 months of follow-up with either > or =3 months (n = 1271) or > or =6 months (n = 251) of exclusive breastfeeding. RESULTS: Infants from the experimental sites were significantly more likely to be breastfed (to any degree) at 3, 6, 9, and 12 months and were far more likely to be exclusively breastfed at 3 months (43.3% vs 6.4%). Mean birth weight was nearly identical in the 2 groups (3448 g, experimental; 3446 g, control). Mean weight was significantly higher in the experimental group by 1 month of age (4341 vs 4280 g). The difference increased through 3 months (6153 g vs 6047 g), declined slowly thereafter, and disappeared by 12 months (10564 g vs 10571 g). Analysis by z scores confirmed that infants in both groups gained more weight than the WHO/Centers for Disease Control and Prevention reference, with no evidence of undernutrition in the control group. Length followed a similar pattern. In the observational analyses, infants weaned in the first month were slightly lighter and shorter at birth and their weight-for-age and length-for-age z scores declined by 1 month, but they caught up to both experimental and the other observational groups by 6 months and were heavier and longer by 12 months. Among infants in the 2 prolonged and exclusive breastfeeding groups, weight-for-age z scores fell slightly between 3 and 12 months; length-for-age fell below the reference by 6 months with catch-up to the reference by 12 months. Head circumference showed no significant differences at any age between the 2 trial groups or among the observational groups. CONCLUSIONS: Our data, the first in humans based on a randomized experiment, suggest that prolonged and exclusive breastfeeding may actually accelerate weight and length gain in the first few months, with no detectable deficit by 12 months old. These results add support to current WHO and UNICEF feeding recommendations. Our observational analysis showing faster weight and length gains with early weaning and slower gains with prolonged and exclusive breastfeeding may reflect unmeasured confounding differences or a true biological effect of formula feeding.