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Effects of Promoting Long-term, Exclusive Breastfeeding on Adolescent Adiposity, Blood Pressure, and Growth Trajectories: A Secondary Analysis of a Randomized Clinical Trial.
Martin, RM, Kramer, MS, Patel, R, Rifas-Shiman, SL, Thompson, J, Yang, S, Vilchuck, K, Bogdanovich, N, Hameza, M, Tilling, K, et al
JAMA pediatrics. 2017;(7):e170698
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Abstract
IMPORTANCE Evidence that breastfeeding reduces child obesity risk and lowers blood pressure (BP) is based on potentially confounded observational studies. OBJECTIVE To investigate the effects of a breastfeeding promotion intervention on adiposity and BP at age 16 years and on longitudinal growth trajectories from birth. DESIGN, SETTING, AND PARTICIPANTS Cluster-randomized Promotion of Breastfeeding Intervention Trial. Belarusian maternity hospitals and affiliated polyclinics (the clusters) were allocated into intervention (n = 16) or control arms (n = 15) in 1996 and 1997. The trial participants were 17 046 breastfeeding mother-infant pairs; of these, 13 557 children (79.5%) were followed up at 16 years of age between September 2012 and July 2015. INTERVENTIONS Breastfeeding promotion, modeled on the Baby-Friendly Hospital Initiative. MAIN OUTCOMES AND MEASURES Body mass index (BMI, calculated as weight in kilograms divided by height in meters squared); fat and fat-free mass indices and percentage of body fat from bioimpedance; waist circumference; overweight and obesity; height; BP; and longitudinal growth trajectories. The primary analysis was modified intention-to-treat (without imputation for losses to follow-up) accounting for within-clinic clustering. RESULTS We examined 13 557 children at a median age of 16.2 years (48.5% were girls). The intervention substantially increased breastfeeding duration and exclusivity compared with the control arm (exclusively breastfed: 45% vs 6% at 3 months, respectively). Mean differences at 16 years between intervention and control groups were 0.21 (95% CI, 0.06-0.36) for BMI; 0.21 kg/m2 (95% CI, -0.03 to 0.44) for fat mass index; 0.00 kg/m2 (95% CI, -0.21 to 0.22) for fat-free mass index; 0.71% (95% CI, -0.32 to 1.74) for percentage body fat; -0.73 cm (-2.48 to 1.02) for waist circumference; 0.05 cm (95% CI, -0.85 to 0.94) for height; -0.54 mm Hg (95% CI, -2.40 to 1.31) for systolic BP; and 0.71 mm Hg (95% CI, -0.68 to 2.10) for diastolic BP. The odds ratio for overweight/obesity (BMI ≥85th percentile vs <85th percentile) was 1.14 (95% CI, 1.02-1.28) and the odds ratio for obesity (BMI ≥95th percentile vs <95th percentile) was 1.09 (95% CI, 0.92-1.29). The intervention resulted in a more rapid rate of gain in postinfancy height (1 to 2.8 years), weight (2.8 to 14.5 years), and BMI (2.8 to 8.5 years) compared with the control arm. The intervention had little effect on BMI z score changes after 8.5 years. CONCLUSIONS AND RELEVANCE A randomized intervention that increased the duration and exclusivity of breastfeeding was not associated with lowered adolescent obesity risk or BP. On the contrary, the prevalence of overweight/obesity was higher in the intervention arm. All mothers initiated breastfeeding, so findings may not apply to comparisons of the effects of breastfeeding vs formula feeding. TRIAL REGISTRATION isrctn.org: ISRCTN37687716; and clinicaltrials.gov: NCT01561612.
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Effects of prenatal multiple micronutrient supplementation on growth and cognition through 2 y of age in rural Bangladesh: the JiVitA-3 Trial.
Christian, P, Kim, J, Mehra, S, Shaikh, S, Ali, H, Shamim, AA, Wu, L, Klemm, R, Labrique, AB, West, KP
The American journal of clinical nutrition. 2016;(4):1175-1182
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Abstract
BACKGROUND Childhood undernutrition may have prenatal origins, and the impact of prenatal interventions on postnatal growth is not well known. OBJECTIVE We assessed the effects of prenatal multiple micronutrient (MM) supplementation on child growth and cognitive development. DESIGN In a cluster-randomized controlled trial in rural Bangladesh, prenatal MM supplementation compared with iron-folic acid (IFA) supplementation was examined for its impact on growth assessed longitudinally from birth up to 24 mo of age (n = 8529) and, in a subsample (n = 734), on cognitive function at 24 mo of age by use of the Bayley scales of infant and toddler development-third edition test. RESULTS Prevalence of stunting at birth [length for age z score (LAZ): <-2] was 31.9% in the MM and 35.7% in the IFA groups (P < 0.001); however, LAZ increased during the first 3-4 mo in both groups. With the use of a linear random-effects model, prenatal MM-exposed children sustained a higher mean predicted LAZ of ∼0.10 at 1 and 3 mo and 0.06 at 6 mo of age compared with children in the IFA group. Supplementation reduced the prevalence of stunting at 1 (RR: 0.95; 95% CI: 0.92, 0.98) and 3 (RR: 0.91; 95% CI: 0.88, 0.94) mo of age. Differences between groups were absent by 6, 12, and 24 mo of age, when nearly 50% of children had stunted growth. Ponderal and linear growth velocities were somewhat slower from 3 to 12 mo of age in the MM group than in the IFA group, but not from 12 to 24 mo of age. There was no difference between groups on composite scores of cognition, language, and motor performance at 24 mo of age. CONCLUSIONS In this Bangladeshi trial, maternal pre- and postnatal MM supplementation resulted in improvements in LAZ and reduction in stunting through 3 mo of age, but not thereafter and had no impact on cognitive and motor function at 2 y. This trial was registered at clinicaltrials.gov as NCT000860470.
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Effect of zinc and multivitamin supplementation on the growth of Tanzanian children aged 6-84 wk: a randomized, placebo-controlled, double-blind trial.
Locks, LM, Manji, KP, McDonald, CM, Kupka, R, Kisenge, R, Aboud, S, Wang, M, Fawzi, WW, Duggan, CP
The American journal of clinical nutrition. 2016;(3):910-8
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BACKGROUND Poor child growth increases risks of mortality and morbidity. Micronutrient supplements have the potential to improve child growth. OBJECTIVE We assessed the effect of daily zinc, multivitamin (vitamins C, E, and B-complex), and zinc and multivitamin (Zn+MV) supplementation on growth in infants in Tanzania. DESIGN In this randomized, 2 × 2 factorial, double-blind trial, 2400 infants were randomly assigned to receive zinc, multivitamins, Zn+MVs, or a placebo at 6 wk of age and were followed up for 18 mo with monthly growth measurements. Mixed-effects models with restricted cubic splines for the mean change in anthropometric z scores were fit for each group. Likelihood ratio tests were used to compare the effect of supplements on growth trajectories. Cox proportional hazards models were used to compare incidences of stunting, wasting, and underweight. RESULTS Children in all groups experienced growth faltering. At 19 mo of age, prevalences of stunting, wasting, and underweight were 19.8%, 6.0%, and 10.8%, respectively. Changes in weight-for-age z scores (WAZs) and weight-for-height z scores (WHZs) were significantly different across the 4 groups (P < 0.001 for both). The mean ± SE decline in the WAZ from baseline to the end of follow-up in the Zn+MV group was significantly less than in the placebo group (-0.36 ± 0.04 compared with -0.50 ± 0.04; P = 0.020), whereas the decline in the WHZ was significantly greater in the zinc-only group than in the placebo group (-0.57 ± 0.07 compared with -0.35 ± 0.07; P = 0.021). Supplements did not have a significant effect on mean change in the height-for-age z score or on rates of stunting, wasting, or underweight. CONCLUSIONS Although there were small but significant improvements in the WAZ in the Zn+MV group, daily zinc supplementation alone, multivitamin supplementation alone, and the combined Zn+MV did not reduce the incidences of underweight, stunting, or wasting in Tanzanian infants. Alternative approaches to prevent growth faltering should be pursued. This trial was registered at clinicaltrials.gov as NCT00421668.
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Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial.
Yousafzai, AK, Rasheed, MA, Rizvi, A, Armstrong, R, Bhutta, ZA
Lancet (London, England). 2014;(9950):1282-93
Abstract
BACKGROUND Stimulation and nutrition delivered through health programmes at a large scale could potentially benefit more than 200 million young children worldwide who are not meeting their developmental potential. We investigated the feasibility and effectiveness of the integration of interventions to enhance child development and growth outcomes in the Lady Health Worker (LHW) programme in Sindh, Pakistan. METHODS We implemented a community-based cluster-randomised effectiveness trial through the LHW programme in rural Sindh, Pakistan, with a 2 × 2 factorial design. We randomly allocated 80 clusters (LHW catchments) of children to receive routine health and nutrition services (controls; n=368), nutrition education and multiple micronutrient powders (enhanced nutrition; n=364), responsive stimulation (responsive stimulation; n=383), or a combination of both enriched interventions (n=374). The allocation ratio was 1:20 (ie, 20 clusters per intervention group). The data collection team were masked to the allocated intervention. All children born in the study area between April, 2009, and March, 2010, were eligible for enrolment if they were up to 2·5 months old without signs of severe impairments. Interventions were delivered by LHWs to families with children up to 24 months of age in routine monthly group sessions and home visits. The primary endpoints were child development at 12 and 24 months of age (assessed with the Bayley Scales of Infant and Toddler Development, Third Edition) and growth at 24 months of age. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT007159636. FINDINGS 1489 mother-infant dyads were enrolled into the study, of whom 1411 (93%) were followed up until the children were 24 months old. Children who received responsive stimulation had significantly higher development scores on the cognitive, language, and motor scales at 12 and 24 months of age, and on the social-emotional scale at 12 months of age, than did those who did not receive the intervention. Children who received enhanced nutrition had significantly higher development scores on the cognitive, language, and social-emotional scales at 12 months of age than those who did not receive this intervention, but at 24 months of age only the language scores remained significantly higher. We did not record any additive benefits when responsive stimulation was combined with nutrition interventions. Responsive stimulation effect sizes (Cohen's d) were 0·6 for cognition, 0·7 for language, and 0·5 for motor development at 24 months of age; these effect sizes were slightly smaller for the combined intervention group and were low to moderate for the enhanced nutrition intervention alone. Children exposed to enhanced nutrition had significantly better height-for-age Z scores at 6 months (p<0·0001) and 18 months (p=0·02) than did children not exposed to enhanced nutrition. Longitudinal analysis showed a small benefit to linear growth from enrolment to 24 months (p=0·026) in the children who received the enhanced nutrition intervention. INTERPRETATION The responsive stimulation intervention can be delivered effectively by LHWs and positively affects development outcomes. The absence of a major effect of the enhanced nutrition intervention on growth shows the need for further analysis of mediating variables (eg, household food security status) that will help to optimise future nutrition implementation design. FUNDING UNICEF.
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Effect of a nutritional supplement on growth in short and lean prepubertal children: a prospective, randomized, double-blind, placebo-controlled study.
Lebenthal, Y, Yackobovitch-Gavan, M, Lazar, L, Shalitin, S, Tenenbaum, A, Shamir, R, Phillip, M
The Journal of pediatrics. 2014;(6):1190-1193.e1
Abstract
OBJECTIVE To determine the effect of nutritional supplementation on height, weight, and body mass index (BMI) in short and lean prepubertal children. STUDY DESIGN A prospective, randomized, double-blinded, placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy, lean, short, prepubertal children 3-9-years-old. Anthropometry measurements were measured at 6 months. RESULTS Two hundred participants (149 boys) entered the study and 171 (85.5%) completed the intervention period. Baseline characteristics including age, sex, height-SDS, weight-SDS, BMI-SDS, and dietary caloric and protein intakes were similar in the formula and placebo groups. 'Good' consumers (intake of ≥50% of the recommended dose) in the formula group significantly improved height-SDS (P < .001) and weight-SDS (P = .005) with no change in BMI-SDS compared with 'poor' consumers and the placebo group. In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS (r = 0.44, P < .001) and weight-SDS (r = 0.35, P = .002); no significant correlations were found in the placebo group. No serious adverse events were reported during the study. CONCLUSIONS Nutritional intervention with the formula was found to be a feasible, effective, and safe approach for promoting the physical growth of short and lean prepubertal children.
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Growth of healthy term infants fed an extensively hydrolyzed casein-based or free amino acid-based infant formula: a randomized, double-blind, controlled trial.
Borschel, MW, Ziegler, EE, Wedig, RT, Oliver, JS
Clinical pediatrics. 2013;(10):910-7
Abstract
A masked, randomized, parallel growth study was conducted in infants fed an amino acid-based formula (AF) or an extensively hydrolyzed casein-based formula (HF). Infants were enrolled between 0 and 9 days and studied to 112 days of age. Growth, formula intake, stool patterns, and serum albumin concentrations were assessed. There were no significant differences between groups in weight, length, or head circumference, gains in weight or length, or study formula intake. The number of stools parents rated as being formed, and the mean daily number of stools were greater in the HF than in the AF group at 14 and 28 days of age. Mean serum albumin concentrations were not significantly different between groups and were within the normal range. This study demonstrates that AF supports normal growth of infants comparable to that of infants fed HF during the critical first 4 months of life.
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Early growth and postprandial appetite regulatory hormone responses.
Perälä, MM, Kajantie, E, Valsta, LM, Holst, JJ, Leiviskä, J, Eriksson, JG
The British journal of nutrition. 2013;(9):1591-600
Abstract
Strong epidemiological evidence suggests that slow prenatal or postnatal growth is associated with an increased risk of CVD and other metabolic diseases. However, little is known whether early growth affects postprandial metabolism and, especially, the appetite regulatory hormone system. Therefore, we investigated the impact of early growth on postprandial appetite regulatory hormone responses to two high-protein and two high-fat content meals. Healthy, 65-75-year-old volunteers from the Helsinki Birth Cohort Study were recruited; twelve with a slow increase in BMI during the first year of life (SGI group) and twelve controls. Subjects ate a test meal (whey meal, casein meal, SFA meal and PUFA meal) once in a random order. Plasma glucose, insulin, TAG, NEFA, ghrelin, peptide tyrosine-tyrosine (PYY), glucose-dependent insulinotropic peptide, glucagon-like peptide-1 and a satiety profile were measured in the fasting state and for 4 h after each test meal. Compared with the controls, the SGI group had about 1·5-fold higher insulin responses after the whey meal (P= 0·037), casein meal (P= 0·023) and PUFA meal (P= 0·002). TAG responses were 34-69 % higher for the SGI group, but only the PUFA-meal responses differed significantly between the groups. The PYY response of the SGI group was 44 % higher after the whey meal (P= 0·046) and 115 % higher after the casein meal (P= 0·025) compared with the controls. No other statistically significant differences were seen between the groups. In conclusion, early growth may have a role in programming appetite regulatory hormone secretion in later life. Slow early growth is also associated with higher postprandial insulin and TAG responses but not with incretin levels.
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Effects of a multi-micronutrient-fortified beverage, with and without sugar, on growth and cognition in South African schoolchildren: a randomised, double-blind, controlled intervention.
Taljaard, C, Covic, NM, van Graan, AE, Kruger, HS, Smuts, CM, Baumgartner, J, Kvalsvig, JD, Wright, HH, van Stuijvenberg, ME, Jerling, JC
The British journal of nutrition. 2013;(12):2271-84
Abstract
Little is known about the effects of combined micronutrient and sugar consumption on growth and cognition. In the present study, we investigated the effects of micronutrients and sugar, alone and in combination, in a beverage on growth and cognition in schoolchildren. In a 2 × 2 factorial design, children (n 414, 6-11 years) were randomly allocated to consume beverages containing (1) micronutrients with sugar, (2) micronutrients with a non-nutritive sweetener, (3) no micronutrients with sugar or (4) no micronutrients with a non-nutritive sweetener for 8.5 months. Growth was assessed and cognition was tested using the Kaufman Assessment Battery for Children version II (KABC-II) subtests and the Hopkins Verbal Learning Test (HVLT). Micronutrients decreased the OR for Fe deficiency at the endpoint (OR 0.19; 95% CI 0.07, 0.53). Micronutrients increased KABC Atlantis (intervention effect: 0.76; 95% CI 0.10, 1.42) and HVLT Discrimination Index (1.00; 95% CI 0.01, 2.00) scores. Sugar increased KABC Atlantis (0.71; 95% CI 0.05, 1.37) and Rover (0.72; 95% CI 0.08, 1.35) scores and HVLT Recall 3 (0.94; 95% CI 0.15, 1.72). Significant micronutrient × sugar interaction effects on the Atlantis, Number recall, Rover and Discrimination Index scores indicated that micronutrients and sugar in combination attenuated the beneficial effects of micronutrients or sugar alone. Micronutrients or sugar alone had a lowering effect on weight-for-age z-scores relative to controls (micronutrients - 0.08; 95% CI - 0.15, - 0.01; sugar - 0.07; 95% CI - 0.14, - 0.002), but in combination, this effect was attenuated. The beverages with micronutrients or added sugar alone had a beneficial effect on cognition, which was attenuated when provided in combination.
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Pregnancy and infant outcomes among HIV-infected women taking long-term ART with and without tenofovir in the DART trial.
Gibb, DM, Kizito, H, Russell, EC, Chidziva, E, Zalwango, E, Nalumenya, R, Spyer, M, Tumukunde, D, Nathoo, K, Munderi, P, et al
PLoS medicine. 2012;(5):e1001217
Abstract
BACKGROUND Few data have described long-term outcomes for infants born to HIV-infected African women taking antiretroviral therapy (ART) in pregnancy. This is particularly true for World Health Organization (WHO)-recommended tenofovir-containing first-line regimens, which are increasingly used and known to cause renal and bone toxicities; concerns have been raised about potential toxicity in babies due to in utero tenofovir exposure. METHODS AND FINDINGS Pregnancy outcome and maternal/infant ART were collected in Ugandan/Zimbabwean HIV-infected women initiating ART during The Development of AntiRetroviral Therapy in Africa (DART) trial, which compared routine laboratory monitoring (CD4; toxicity) versus clinically driven monitoring. Women were followed 15 January 2003 to 28 September 2009. Infant feeding, clinical status, and biochemistry/haematology results were collected in a separate infant study. Effect of in utero ART exposure on infant growth was analysed using random effects models. 382 pregnancies occurred in 302/1,867 (16%) women (4.4/100 woman-years [95% CI 4.0-4.9]). 226/390 (58%) outcomes were live-births, 27 (7%) stillbirths (≥22 wk), and 137 (35%) terminations/miscarriages (<22 wk). Of 226 live-births, seven (3%) infants died <2 wk from perinatal causes and there were seven (3%) congenital abnormalities, with no effect of in utero tenofovir exposure (p>0.4). Of 219 surviving infants, 182 (83%) enrolled in the follow-up study; median (interquartile range [IQR]) age at last visit was 25 (12-38) months. From mothers' ART, 62/9/111 infants had no/20%-89%/≥90% in utero tenofovir exposure; most were also zidovudine/lamivudine exposed. All 172 infants tested were HIV-negative (ten untested). Only 73/182(40%) infants were breast-fed for median 94 (IQR 75-212) days. Overall, 14 infants died at median (IQR) age 9 (3-23) months, giving 5% 12-month mortality; six of 14 were HIV-uninfected; eight untested infants died of respiratory infection (three), sepsis (two), burns (one), measles (one), unknown (one). During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0.1). There was no evidence that in utero tenofovir affected growth after 2 years (p = 0.38). Attained height- and weight for age were similar to general (HIV-uninfected) Ugandan populations. Study limitations included relatively small size and lack of randomisation to maternal ART regimens. CONCLUSIONS Overall 1-year 5% infant mortality was similar to the 2%-4% post-neonatal mortality observed in this region. No increase in congenital, renal, or growth abnormalities was observed with in utero tenofovir exposure. Although some infants died untested, absence of recorded HIV infection with combination ART in pregnancy is encouraging. Detailed safety of tenofovir for pre-exposure prophylaxis will need confirmation from longer term follow-up of larger numbers of exposed children. TRIAL REGISTRATION www.controlled-trials.com ISRCTN13968779
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Use of lipid-based nutrient supplements by HIV-infected Malawian women during lactation has no effect on infant growth from 0 to 24 weeks.
Flax, VL, Bentley, ME, Chasela, CS, Kayira, D, Hudgens, MG, Knight, RJ, Soko, A, Jamieson, DJ, van der Horst, CM, Adair, LS
The Journal of nutrition. 2012;(7):1350-6
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Abstract
The Breastfeeding, Antiretrovirals, and Nutrition Study evaluated the effect of daily consumption of lipid-based nutrient supplements (LNS) by 2121 lactating, HIV-infected mothers on the growth of their exclusively breast-fed, HIV-uninfected infants from 0 to 24 wk. The study had a 2 × 3 factorial design. Malawian mothers with CD4(+) ≥250 cells/mm(3), hemoglobin ≥70 g/L, and BMI ≥17 kg/m(2) were randomized within 36 h of delivery to receive either no LNS or 140 g/d of LNS to meet lactation energy and protein needs, and mother-infant pairs were assigned to maternal antiretroviral drugs (ARV), infant ARV, or no ARV. Sex-stratified, longitudinal, random effects models were used to estimate the effect of the 6 study arms on infant weight, length, and BMI. Logistic regression models were used to calculate the odds of growth faltering [decline in weight-for-age Z-score (WAZ) or length-for-age Z-score (LAZ) >0.67] using the control arm as the reference. Although some differences between study arms emerged with increasing infant age in boys, there were no consistent effects of the maternal supplement across the 3 growth outcomes in longitudinal models. At the ages where differences were observed, the effects on weight and BMI were quite small (≤200 g and ≤0.4 kg/m(2)) and unlikely to be of clinical importance. Overall, 21 and 34% of infants faltered in WAZ and LAZ, respectively. Maternal supplementation did not reduce the odds of infant weight or length faltering from 0 to 24 wk in any arm. These results indicate that blanket supplementation of HIV-infected lactating women may have little impact on infant growth.