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Complementary feeding: a Global Network cluster randomized controlled trial.

ABSTRACT: Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.NCT01084109.

SUBMITTER: Krebs NF

PROVIDER: S-EPMC3032692 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Complementary feeding: a Global Network cluster randomized controlled trial.

Krebs Nancy F NF Hambidge K Michael KM Mazariegos Manolo M Westcott Jamie J Goco Norman N Wright Linda L LL Koso-Thomas Marion M Tshefu Antoinette A Bose Carl C Pasha Omrana O Goldenberg Robert R Chomba Elwyn E Carlo Waldemar W Kindem Mark M Das Abhik A Hartwell Ty T McClure Elizabeth E

BMC pediatrics 20110113

<h4>Background</h4>Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.<h4>Methods/design</h4>A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of ...[more]

PMID: 21232139

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Project description:BackgroundStarting complementary feeding (CF) with vegetables only may improve vegetable acceptance throughout childhood.ObjectivesWe aimed to test whether exposure to vegetables only during the first 4 wk of CF increases later vegetable acceptance compared with a control group receiving fruit and vegetables.MethodsIn this randomized, controlled, parallel-group study, 117 Auckland infants received either vegetables only (veg-only, n = 61) or a combination of fruit and vegetables (control, n = 56) for a duration of 4 wk, starting from the first day of CF at ∼4-6 mo of age. The primary outcome measure was intake of target vegetables (broccoli, spinach) provided by the study at 9 mo of age. Daily intake of vegetables (FFQs) at 9 mo was a supporting measure. Infants' iron status (serum ferritin, hemoglobin) was examined at all time points.ResultsThe veg-only infants consumed more broccoli and spinach than controls [mean difference (95% CI): 11.83 (0.82, 22.84) g, P = 0.036 and 10.19 (0.50, 19.87) g, P = 0.039, respectively]. Intake of pear was comparable among intervention groups (P = 0.35). At 9 mo, veg-only infants consumed target vegetables at a faster rate [mean difference (95% CI): broccoli, 3.37 (1.26, 5.47), P = 0.002; spinach, 4.12 (0.80, 7.45), P = 0.016] and showed greater acceptance for target vegetables [mean difference (95% CI): broccoli, 0.38 (0.07, 0.70), P = 0.019; spinach, 032 (0.04, 0.60), P = 0.024] than controls. The rate of eating and acceptance of pear was comparable among intervention groups (P = 0.42 and P = 0.98, respectively). Also, veg-only infants consumed more vegetables than controls [86.3 (52.5, 146.3) compared with 67.5 (37.5, 101.3) g, respectively, P = 0.042]. Introducing vegetables as the first food was not associated with 9-mo iron status.ConclusionsProviding vegetables as first foods increased vegetable intake at 9 mo of age and may be an effective strategy for improving child vegetable consumption and developing preferences for vegetables in infancy.

Project description:Background: Choline status has been associated with stunting among young children. Findings from this study showed that an egg intervention improved linear growth by a length-for-age z score of 0.63.Objective: We aimed to test the efficacy of eggs introduced early in complementary feeding on plasma concentrations of biomarkers in choline pathways, vitamins B-12 and A, and essential fatty acids.Design: A randomized controlled trial, the Lulun ("egg" in Kichwa) Project, was conducted in a rural indigenous population of Ecuador. Infants aged 6-9 mo were randomly assigned to treatment (1 egg/d for 6 mo; n = 80) and control (no intervention; n = 83) groups. Socioeconomic data, anthropometric measures, and blood samples were collected at baseline and endline. Household visits were made weekly for morbidity surveillance. We tested vitamin B-12 plasma concentrations by using chemiluminescent competitive immunoassay and plasma concentrations of choline, betaine, dimethylglycine, retinol, essential fatty acids, methionine, dimethylamine (DMA), trimethylamine, and trimethylamine-N-oxide (TMAO) with the use of liquid chromatography-tandem mass spectrometry.Results: Socioeconomic factors and biomarker concentrations were comparable at baseline. Of infants, 11.4% were vitamin B-12 deficient and 31.7% marginally deficient at baseline. In adjusted generalized linear regression modeling, the egg intervention increased plasma concentrations compared with control by the following effect sizes: choline, 0.35 (95% CI: 0.12, 0.57); betaine, 0.29 (95% CI: 0.01, 0.58); methionine, 0.31 (95% CI: 0.03, 0.60); docosahexaenoic acid, 0.43 (95% CI: 0.13, 0.73); DMA, 0.37 (95% CI: 0.37, 0.69); and TMAO, 0.33 (95% CI: 0.08, 0.58). No significant group differences were found for vitamin B-12, retinol, linoleic acid (LA), α-linolenic acid (ALA), or ratios of betaine to choline and LA to ALA.Conclusion: The findings supported our hypothesis that early introduction of eggs significantly improved choline and other markers in its methyl group metabolism pathway. This trial was registered at clinicaltrials.gov as NCT02446873.

Project description:BACKGROUND:What we eat as infants and children carries long-term consequences. Apart from breastfeeding, the composition of the complementary diet, i.e. the foods given to the infant during the transition from breast milk/infant formula to regular family foods affects the child's future health. A high intake of protein, a low intake of fruits, vegetables and fish and an unfavorable distribution between polyunsaturated and saturated fats are considered to be associate with health risks, e.g. obesity, type 2 diabetes and dyslipidemia later in life. METHODS:In a randomized, controlled study from 6 to 18?months of age we will compare the currently recommended, Swedish complementary diet to one based on Nordic foods, i.e. an increased intake of fruits, berries, vegetables, tubers, whole-grain and game, and a lower intake of sweets, dairy, meat and poultry, with lower protein content (30% decrease), a higher intake of vegetable fats and fish and a systematic introduction of fruits and greens. The main outcomes are body composition (fat and fat-free mass measured with deuterium), metabolic and inflammatory biomarkers (associated with the amount of body fat) in blood and urine, gut microbiota (thought to be the link between early diet, metabolism and diseases such as obesity and insulin resistance) and blood pressure. We will also measure the participants' energy and nutrient intake, eating behavior and temperament through validated questionnaires, acceptance of new and unfamiliar foods through video-taped test meals and assessment of cognitive development, which we believe can be influenced through an increased intake of fish and milk fats, notably milk fat globule membranes (MFGM). DISCUSSION:If the results are what we expect, i.e. improved body composition and a less obesogenic, diabetogenic and inflammatory metabolism and gut microbiota composition, a more sustainable nutrient intake for future health and an increased acceptance of healthy foods, they will have a profound impact on the dietary recommendations to infants in Sweden and elsewhere, their eating habits later in life and subsequently their long-term health. TRIAL REGISTRATION:NCT02634749 . Registration date 18 December 2015.

Project description:BackgroundAttaining the recommended level of complementary feeding practices remains a serious challenge in many developing countries. Complementary foods are usually untimely initiated, which has adverse consequences on the growth, development, and survival of infants. The focus of most studies conducted worldwide seemed to be on the effect of behavior change interventions on the adequacy of complementary diets; but not on the timing of initiations. Moreover, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged the family members are scarce. This study aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through women development army leaderson the time of initiation of complementary foods.MethodsWe conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia from February 2017 to March 2018. A total of 16 geographic clusters were selected. Trial participants in the intervention group received complementary feeding behavior change intervention for 9 months whereas those in the control group received only the usual health care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimated equation (GEE) regression and survival analyses were used to test differences in time of initiation of complementary food between the study groups.ResultsThe intervention significantly improved the likelihood of timely initiation of complementary food by 22 percentage points [RR: 2.6; 95% CI: 1.78-5.86], and reduced the risk of late initiations by 19 percentage points [RR: 2.8; 95% CI: 1.83-4.37]. The complementary food initiation survival curve for the control group after 6 months was constantly above the curve than for the intervention group. The median age at the introduction of complementary food for infants was 6 months in the intervention group, and 6.7 months in the control group and the difference was statistically significant (P-value < 0.001).ConclusionsComplementary feeding behavior change communication improved the rate of timely initiation of complementary foods and reduced the risk of late initiations.Trial registrationClinicalTrials.gov , NCT03488680 . Registered 5 April 2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03488680 .

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Complementary feeding: a Global Network cluster randomized controlled trial.

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Complementary feeding: a Global Network cluster randomized controlled trial.

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