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Effect of Personalized Nutrition Counseling in Pregnant Women After Bariatric Surgery on Nutritional Status and Habits

4 de abril de 2019 atualizado por: Rambam Health Care Campus

The Effect of Personalized Tailored Nutrition Counseling in Pregnant Women After Bariatric Surgery on Compliance and Nutritional Habits

Background: Nutrition challenges follow bariatric surgery can intensify during pregnancy and may have a crucial effect on fetus. To the best of the investigators knowledge, the effect of nutritional counseling on improvement of maternal diet quality and eating habits among post- bariatric pregnant women has not been evaluated.

Objective: study aims to expand the existing limited knowledge in respect to post bariatric pregnant women's eating habits and quality of food intake, and to investigate the impact of nutrition counseling on these factors.

Design: This is a controlled clinical trial comparing post Laparoscopic sleeve gastrectomy (LSG) pregnant women who received nutritional counseling with age-matched control healthy pregnant women. Counseling will focus on improving quality of food consumption, eating habits and behavioral changes in order to improve the mother and the fetus' nutritional status Nutritional data and eating behavior will be obtained using 24 hours recall dietary records and the Family Eating and Activity Habit Questionnaire (FEAHQ).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Introduction Pregnancy is a critical period that can determine health for years to come. Appropriate nutrition during pregnancy is key to improved survival and health status of offspring, and can prevent numerous disease states from infancy to adult life. In recent year, as obesity has become a rising problem, bariatric surgery is the only way for many women to increase the chances of fertility.

A possible adverse effect of this approach is high frequency of nutritional deficiencies reported among this population, which may be critical in cases of pregnancy.

The risk for sub-optimal nutritional status and consequently a potential risk of developing micro and macronutrients deficiencies in post bariatric pregnancies, are higher compared to non-surgical pregnant women, given the nutrition challenges brought about by the surgery such as food aversions, nausea, and vomiting beyond the increased nutritional requirements exist in healthy pregnancy. Furthermore, even without the existence of nutritional deficiencies, maternal diet quality has a critical effect on fetus. "Western" diet, high in fats and sugars, increased sympathetic nervous system activity and hyperactivity in rodent offspring that persisted into adulthood. However Investigation of diet quality during pregnancy among women with bariatric surgery has shown that 82% of women's diet quality needs improvement. Moreover, dietary modifications are mainly directed towards increased pollution safety rather than improving diet quality in order to improve the mother and the fetus' nutritional status.

To the best of the investigators knowledge, the effect of dietary counseling in post bariatric pregnant women has not been evaluated despite the findings about its importance and efficacy in studies on non-pregnant bariatric patient.

The aims of this study is to expand the existing limited knowledge in respect to post bariatric pregnant women's' eating habits and quality of food intake, and to investigate the impact of nutrition counseling on these factors, which to best of the investigators knowledge had never been published.

Intervention Patients from the intervention group will receive nutritional counseling from a specialist bariatric dietitian trained in pregnancy nutrition as well. The main goals are a healthy balanced diet including adequate daily servings from all food groups (dairy and egg, meat, vegetables, fruit, whole grain starches, and healthy fats), intake of essential nutrient during pregnancy such as iron and folic acid and limitation of high-sugar and fatty foods. In addition, the patients were advised concerning eating at scheduled times (e.g., 4-6 times daily), taking supplements, preference of water. Advice concerning healthy cooking methods will also be provided. Participants will be advised to avoid soft drinks, drinking during meals, grazing and emotional eating, as well as fast foods. Also the subject of lifestyle in general will be addressed, and participants will be encouraged to incorporate suitable physical activity on most days, refraining from alcohol, and smoking. As currently, no guidelines exist in the literature for nutrition or behavioral modifications for pregnancy after LSG, counseling is based on previously published literature for bariatric and healthy pregnancy nutrition separately.

Each participant will received 8 follow-up sessions for dietary counseling.

Tipo de estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Haifa, Israel
        • Rambam MC

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Pregnancy
  • Bariatric surgery
  • Laparoscopic sleeve gastrectomy
  • control group - healthy pregnant women

Exclusion Criteria:

  • multiple pregnancy
  • chronic diseases
  • post 15 weeks pregnancy.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: intervention group
Pregnant post bariatric surgery women will receive nutritional counseling from a specialist dietitian, to ensure a healthy balanced diet including adequate daily servings from all food groups, intake of essential nutrient during pregnancy such as iron and folic acid and limitation of high-sugar and fatty foods. Patients will also be advised concerning eating at scheduled times (e.g., 4-6 times daily), supplements, preference of water. Advice concerning healthy cooking methods will also be given, as well as advised to avoid soft drinks, drinking during meals, grazing and emotional eating, and fast foods. Subject of lifestyle in general - encouraged to incorporate suitable physical activity on most days, refraining from alcohol, and smoking. intervention: nutrition counseling
nutrition counseling and guidance.
Outros nomes:
  • follow-up
Sem intervenção: control group
The control group is comprised of healthy pregnant women, of similar age, smoking behavior and background. No treatment will be given, just follow-up data collection.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Nutrient intake
Prazo: at inclusion (Time 1),will be compared to recommendation for each individual
24 hour dietary intake and a questionaires on eating habits.
at inclusion (Time 1),will be compared to recommendation for each individual
Nutrient intake
Prazo: gestational week 20 (time 2), will be compared to recommendation for each individual
24 hour dietary intake and a questionaires on eating habits.
gestational week 20 (time 2), will be compared to recommendation for each individual
Nutrient intake
Prazo: gestational week 30 (time 3), will be compared to recommendation for each individual
24 hour dietary intake and a questionaires on eating habits.
gestational week 30 (time 3), will be compared to recommendation for each individual

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2018

Conclusão Primária (Real)

1 de novembro de 2018

Conclusão do estudo (Real)

1 de novembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

3 de fevereiro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de fevereiro de 2016

Primeira postagem (Estimativa)

3 de março de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de abril de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de abril de 2019

Última verificação

1 de abril de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 0309-15 - RBM

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em nutrition counseling

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