Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial

Abstract

Background: Evidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child's weight and height will be investigated.Methods: This is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24 months of age will be further obtained from medical records.

Effectiveness of a minimally processed food-based nutritional counselling intervention on weight gain in overweight pregnant women: a randomized controlled trial

“…This was a two-armed parallel randomized controlled trial conducted among overweight, pregnant women receiving prenatal care in seven primary health units of Ribeirão Preto, São Paulo state, Brazil, described in detail in the publication of Sartorelli et al [24].…”

“…The original study protocol [24] predicted that nutritional counselling sessions would take place at predetermined gestation periods: with the first meeting being conducted up to the 19th gestational week (GW), the second meeting between the 20th and 26th GW, and the third meeting between the 27th and 33rd GW. However, due to the high rate of absenteeism observed in the prenatal consultations of the women included in the study, it was decided to make the intervention period more flexible, maintaining the three sessions between the first and second study evaluations.…”

Do Lifestyle Interventions in Pregnant Women with Overweight or Obesity Have an Effect on Neonatal Adiposity? A Systematic Review with Meta-Analysis

“…Evidence suggests that preconception maternal excessive body weight is associated with greater adiposity in children [17]. Recent studies have investigated the developmental origins of health and disease [18][19][20][21][22][23][24][25], with the adiposity of the newborn being a significant predictor of morbidity in the neonatal period and throughout life [26]. This review aimed to assess the effect of lifestyle interventions in pregnant women with overweight or obesity on neonatal adiposity.…”

Relação entre a qualidade da dieta e o perfil bioquímico em gestantes com sobrepeso

“…Trata-se de um estudo transversal que empregou os dados da linha de base de um ensaio clínico aleatorizado controlado, cujo objetivo foi avaliar a efetividade de uma intervenção nutricional, baseada no incentivo ao consumo de alimentos in natura e minimamente processados, e à prática de atividades físicas, na adequação do ganho de peso em gestantes adultas com sobrepeso As Unidades Básicas de Saúde foram selecionadas de acordo com a alta demanda de pré-natal e a infraestrutura mínima necessária para realizar o estudo (SARTORELLI et al, 2020).…”

“…Foi considerado um nível mínimo de significância de 5% (α = 0,05) e um poder de 90% (β = 0,1). No início, a amostra foi calculada considerandose uma perda de seguimento de 20%, entretanto, devido à pandemia, a perda de seguimento foi bastante superior (40%), exigindo o recálculo do tamanho amostral, que passou a ser de 350 gestantes (SARTORELLI et al, 2020). No presente estudo, a amostragem foi não probabilística do tipo conveniente (LUNA et al, 1998), sendo incluídas todas as gestantes que concluíram a primeira avaliação do ensaio clínico.…”