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

2019년 4월 4일 업데이트: 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).

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

설명

Inclusion Criteria:

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

Exclusion Criteria:

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • follow-up
간섭 없음: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Nutrient intake
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 5월 1일

기본 완료 (실제)

2018년 11월 1일

연구 완료 (실제)

2018년 11월 1일

연구 등록 날짜

최초 제출

2016년 2월 3일

QC 기준을 충족하는 최초 제출

2016년 2월 28일

처음 게시됨 (추정)

2016년 3월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 4월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 4월 4일

마지막으로 확인됨

2019년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 0309-15 - RBM

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

임신에 대한 임상 시험

nutrition counseling에 대한 임상 시험

3
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