Oferta de alimentos ultraprocessados no primeiro ano de vida em crianças submetidas a três métodos de introdução alimentar : um ensaio clinico randomizado

Objetivo: Verificar a influência dos métodos de alimentação complementar com a exposição a alimentos ultraprocessados (AUP) no primeiro ano de vida. Métodos: Este ensaio clínico randomizado envolveu pares de mãe-lactentes, alocados em três grupos de introdução alimentar: método tardicional; Introdução estrita aos sólidos guiada pelo bebê (BLISS) ou método misto. A intervenção consistiu em uma sessão de aconselhamento sobre alimentação saudável aos 5,5 meses de idade da criança. Um questionário estruturado foi elaborado com base na classificação NOVA para definição de AUP e aplicado aos nove e doze meses por telefone. O efeito do método de alimentação complementar foi medido comparando as medianas e uma curva de sobrevida da oferta de AUP pela primeira vez no primeiro ano de vida entre os grupos. A regressão de Cox foi usada para estimar sua magnitude. Resultados: Um total de 139 pares foram elegíveis. A prevalência de lactentes expostos à AUP foi de 59,3% (n = 76/128). Em comparação com o PLW, o BLISS / método misto consumiu menos AUP (53,4% versus 71,4%). Ao comparar as medianas do tempo de início da introdução entre os grupos, observou-se que os grupos de abordagem guiada pelo bebê postergaram o uso desses alimentos em 15 dias em relação ao grupo tradicional (270 versus 285 dias). A intervenção para BLISS / método misto reduziu a ingestão de AUP no primeiro ano de vida (razão de risco 0,63; intervalo de confiança de 95% 0,40 - 0,99). Conclusão: O consumo de AUP foi alto independentemente do método. Nossos resultados indicam que os métodos de abordagem conduzida por bebês atrasaram a oferta de AUP em nossa amostra.Objective: To verify the influence of complementary feeding methods with the exposure to ultra-processed foods (UPF) in the first year of life. Methods: This randomized clinical trial involved pairs of mother-infants, allocated in three groups of food introduction: strict Parent-Led Weaning (PLW); strict Baby-Led Introduction to SolidS (BLISS) or mixed-method. The intervention consisted on a counseling session on healthy eating at the child’s 5.5 months of age. A structured questionnaire was created based on the NOVA classification for definition of UPF and applied at nine and twelve months by telephone. The effect of the complementary feeding method was measured by comparing the medians and a survival curve for UPF offer for the first time in the first year of life between groups. Cox regression was used to estimate its magnitude. Results: A total of 139 pairs were eligible. The prevalence of infants who were exposed to UPF was 59.3% (n = 76/128). Compared to the PLW, BLISS/mixed method consumed less UPF (53.4% versus 71.4%). By comparing the medians of the time of UPF initiation between groups, it was observed that baby-led approach groups postponed the use of these foods in 15 days in relation to the PLW group (270 versus 285 days). The intervention for BLISS/mixed-method reduced the intake of UPF in the first year of life (hazard ratio 0.63; 95% confidence interval 0.40 – 0.99). Conclusion: The UPF consumption was high regardless the method, our findings indicate that baby-led approach methods delayed the UPF offer in our sample

Can the complementary feeding method be a strategy to reduce the offer of ultra-processed foods?

Objective: To verify the prevalence of the offer of ultra-processed foods (UPFs), and to analyze their associated factors in the child's first year of life. Methods: Cross-sectional study with 119 mother-infant pairs. At 5.5 months of the child, the mothers received guidance on complementary feeding (CF) according to three methods: Parent-Led Weaning (PLW), Baby-Led Introduction to SolidS (BLISS), or mixed (a combination of PLW and BLISS). At nine and 12 months, the mothers answered a questionnaire about the offer of UPFs. The NOVA classification, which classifies foods according to the nature, extent, and purposes of the industrial processes to which they are subjected, was used to list the UPFs. Descriptive statistics and multivariate Poisson regression, following a multilevel hierarchical model according to the proximity to the outcome, were used to estimate the association between dependent and independent variables. Results: The prevalence of UPF consumption was 63% (n = 75) in the first year of life. Receiving guidance on healthy CF in the BLISS method showed to be a protective factor for offering UPFs (RR 0.72; CI95 0.52-0.99). Attending less than six prenatal consultations was a risk factor for the UPFs provision (RR 1.39; CI95 1.07-1.80). Conclusion: The prevalence of UPFs offered in the first year of life in this study can be considered high, and future interventions aimed at avoiding UPFs offered in this population should consider the CF method

Complementary feeding methods in the first year of life: a study protocol for a randomized clinical trial

Background: The traditional spoon-feeding approach to introduction of solid foods during the complementary feeding period is supported by consensus in the scientific literature. However, a method called Baby-Led Introduction to SolidS (BLISS) has been proposed as an alternative, allowing infants to self-feed with no adult interference. To date, there have been no trials in the Brazilian population to evaluate the effectiveness of BLISS in comparison to the traditional approach. Methods/design: To evaluate and compare three different complementary feeding methods. Data on 144 mother child pairs will be randomized into intervention groups by methods: (A) strict Parent-Led Weaning; (B) strict Baby Led Introduction to SolidS; and (C) a mixed method. Prospective participants from Porto Alegre, Brazil, and nearby cities will be recruited through the Internet. The interventions will be performed by nutritionists and speech therapists, at 5.5 months of age of the child, at a private nutrition office equipped with a test kitchen where meals will be prepared according to the randomized method. The pairs will be followed up at 7, 9, and 12 months of age. Data will be collected through questionnaires designed especially for this study, which will include a 24h child food recall, questionnaires on the child’s and parents’ eating behavior, oral habits, eating difficulties, and choking prevalence. At 12 months of age, children will undergo blood collection to measure hemoglobin, ferritin, and C reactive protein, saliva collection for analysis of genetic polymorphisms, and oral examination. Anthropometric parameters (child and maternal) will be measured at the baseline intervention, at a 9 month home visit, and at the end-of-study visit at the hospital. The primary outcome will be child growth and nutritional status z-scores at 12 months; secondary outcomes will include iron status, feeding behavior, acceptability of the methods, dietary variety, choking, eating behaviors, food preferences, acceptance of bitter and sweet flavors, suction, oral habits, oral hygiene behavior, dental caries, gingival health status, and functional constipation. Discussion: The trial intends to ascertain whether there are potential advantages to the BLISS complementary feeding method in this specific population, generating data to support families and healthcare providers

Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting

Increasing numbers of drugs are being developed for the treatment of multiple sclerosis (MS). Measurement of relevant outcomes is key for assessing the efficacy of new drugs in clinical trials and for monitoring responses to disease-modifying drugs in individual patients. Most outcomes used in trial and clinical settings reflect either clinical or neuroimaging aspects of MS (such as relapse and accrual of disability or the presence of visible inflammation and brain tissue loss, respectively). However, most measures employed in clinical trials to assess treatment effects are not used in routine practice. In clinical trials, the appropriate choice of outcome measures is crucial because the results determine whether a drug is considered effective and therefore worthy of further development; in the clinic, outcome measures can guide treatment decisions, such as choosing a first-line disease-modifying drug or escalating to second-line treatment. This Review discusses clinical, neuroimaging and composite outcome measures for MS, including patient-reported outcome measures, used in both trials and the clinical setting. Its aim is to help clinicians and researchers navigate through the multiple options encountered when choosing an outcome measure. Barriers and limitations that need to be overcome to translate trial outcome measures into the clinical setting are also discussed

Adesão a diferentes métodos de introdução da alimentação complementar aos 7 meses de vida : um ensaio clínico randomizado

Objective: To assess the adherence to three methods of food introduction for 7-month-old babies. Methods: This is a randomized clinical trial conducted with motherinfant pairs, submitted to the intervention with five and a half months of age and three different methods for food introduction according to randomization: Parent-Led Weaning (PLW), BabyLed Introduction to SolidS (BLISS), or mixed (specially developed for this study). Adherence to the method was assessed at the seventh month of age, via telephone call to the caregiver by a researcher blinded to the method. The analyses were performed using the Chi-Square test and data are presented in absolute numbers and percentages. Results: A total of 139 mother-infant pairs were evaluated; 46 of them were allocated to the PLW method; 47, to the BLISS; and 46, to the mixed. At seven months of age, 60 (43.2%) mothers reported that the infants were following the proposed feeding method. When analyzing each approach, the mixed method showed a higher likelihood of adherence (71.7%, n=33), followed by the PLW method (39.1%, n=18) and by the BLISS (19.2%, n=9) (p<0.001). Among the sample that did not follow the proposed method, those that had been randomized to the PLW and BLISS methods mostly migrated to the mixed method (92.9%; n=26 and 92.1%; n=35, respectively) (p<0.001). Conclusions: Complementary feeding in a mixed approach obtained greater adherence in 7-month-old babies.Objetivo: Avaliar a adesão a três métodos de introdução alimentar aos 7 meses de vida. Métodos: Ensaio clínico randomizado com pares mães-lactentes submetidos à intervenção aos 5 meses e meio de vida sobre três diferentes métodos de introdução alimentar, conforme randomização: tradicional, Baby-Led Introduction to SolidS (introdução de sólidos guiada pelo bebê, em português) ou misto (criado especialmente para este estudo). A adesão ao método foi avaliada aos 7 meses em ligação telefônica feita para o cuidador por pesquisador cego em relação ao método. As análises foram realizadas por teste do qui-quadrado e os dados apresentados em número absoluto e percentual. Resultados: Foram avaliados 139 pares mães-lactentes, 46 alocados no método tradicional, 47 no Baby-Led Introduction to SolidS e 46 no misto. Aos 7 meses, 60 (43,2%) mães relataram que seus lactentes seguiam o método alimentar proposto. Analisando-se cada abordagem, o método misto apresentou maior probabilidade de adesão (71,7%, n=33), seguido do tradicional (39,1%, n=18) e de introdução de sólidos guiada pelo bebê (19,2%, n=9) (p<0,001). Da amostra que não seguiu o método proposto, aqueles que haviam sido randomizados para os métodos tradicional e de introdução de sólidos guiada pelo bebê migraram majoritariamente para o misto (92,9%; n=26 e 92,1%; n=35, respectivamente) (p<0,001). Conclusões: A alimentação complementar em abordagem mista obteve maior adesão aos 7 meses de idade

Complementary feeding methods and introduction of ultra-processed foods : a randomized clinical trial

Introduction: Complementary feeding (CF) is defined as a period when foods, other than milk, are introduced to the infant’s diet. Unfortunately, frequent consumption of ultra-processed foods (UPF) has become highly prevalent early in an infant’s life. The aim was to verify the association of CF methods with the introduction of UPF in early childhood. Methods: This randomized clinical trial involved pairs of mother-infants, allocated in groups receiving different CF interventions: strict Parent-Led Weaning (PLW); strict Baby-Led Introduction to SolidS (BLISS), or mixedmethod. The intervention consisted of a counseling session on healthy eating at the child’s 5.5 months of age. A structured questionnaire was created based on the NOVA classification for the definition of UPF and applied at 9 and 12 months. The effect of the CF method intervention was measured by a survival curve for UPF offered for the first time in early childhood between groups. Cox regression was used to estimate its magnitude. The primary analysis was done in three groups (PLW, BLISS, and Mixed) and the secondary analysis was done in two groups (PLW, and BLISS + Mixed). Results: A total of 139 mother-infant pairs were eligible and 129 followed the study. The prevalence of infants who were exposed to UPF in early childhood was 58.9% (n = 76), being 71.4% in the PLW group, 53.3% in the BLISS group, and 52.4% in the Mixed group, without differences between them (p = 0.133). The PLW group intervention had a greater chance of exposure to ice cream or popsicles (p = 0.032) and sweet crackers (p = 0.009), compared with the other two CF groups. The Cox regression did not find significant differences between the three groups. However, the regression with two groups estimated a 38% reduction in the offer of UPF in the BLISS + Mixed group intervention (p = 0.049). Discussion: The CF intervention promoting greater infant autonomy (BLISS and Mixed) was associated with a reduction in the offer of UPF in early childhood. This knowledge may contribute to supporting strategies aimed at reducing UPF consumption by the young infant