- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697981
Effect of Personalized Nutrition Counseling in Pregnant Women After Bariatric Surgery on Nutritional Status and Habits
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).
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Rambam MC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnancy
- Bariatric surgery
- Laparoscopic sleeve gastrectomy
- control group - healthy pregnant women
Exclusion Criteria:
- multiple pregnancy
- chronic diseases
- post 15 weeks pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
Other Names:
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutrient intake
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Barker DJP. Sir Richard Doll Lecture. Developmental origins of chronic disease. Public Health. 2012 Mar;126(3):185-189. doi: 10.1016/j.puhe.2011.11.014. Epub 2012 Feb 10.
- Bebber FE, Rizzolli J, Casagrande DS, Rodrigues MT, Padoin AV, Mottin CC, Repetto G. Pregnancy after bariatric surgery: 39 pregnancies follow-up in a multidisciplinary team. Obes Surg. 2011 Oct;21(10):1546-51. doi: 10.1007/s11695-010-0263-3.
- Verger EO, Aron-Wisnewsky J, Dao MC, Kayser BD, Oppert JM, Bouillot JL, Torcivia A, Clement K. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up. Obes Surg. 2016 Apr;26(4):785-96. doi: 10.1007/s11695-015-1803-7.
- Guelinckx I, Devlieger R, Donceel P, Bel S, Pauwels S, Bogaerts A, Thijs I, Schurmans K, Deschilder P, Vansant G. Lifestyle after bariatric surgery: a multicenter, prospective cohort study in pregnant women. Obes Surg. 2012 Sep;22(9):1456-64. doi: 10.1007/s11695-012-0675-3.
- Kafri N, Valfer R, Nativ O, Shiloni E, Hazzan D. Health behavior, food tolerance, and satisfaction after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2011 Jan-Feb;7(1):82-8. doi: 10.1016/j.soard.2010.09.016. Epub 2010 Oct 31.
- Stein J, Stier C, Raab H, Weiner R. Review article: The nutritional and pharmacological consequences of obesity surgery. Aliment Pharmacol Ther. 2014 Sep;40(6):582-609. doi: 10.1111/apt.12872. Epub 2014 Jul 30.
- Kaiser LL, Campbell CG; Academy Positions Committee Workgroup. Practice paper of the Academy of Nutrition and Dietetics abstract: nutrition and lifestyle for a healthy pregnancy outcome. J Acad Nutr Diet. 2014 Sep;114(9):1447. doi: 10.1016/j.jand.2014.07.001.
- Araki S, Shani Levi C, Abutbul Vered S, Solt I, Rozen GS. Pregnancy after bariatric surgery: Effects of personalized nutrition counseling on pregnancy outcomes. Clin Nutr. 2022 Feb;41(2):288-297. doi: 10.1016/j.clnu.2021.11.035. Epub 2021 Dec 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0309-15 - RBM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy
-
Far Eastern Memorial HospitalCompletedCornual PregnancyTaiwan
-
Peking Union Medical College HospitalPeking Union Medical CollegeUnknownPregnancy | Pregnancy Related | Infant | Pregnancy Disease | Risk FactorChina
-
Ufuk UniversityNot yet recruitingPregnancy Complications | Pregnancy Loss | Pregnancy Preterm
-
Hadassah Medical OrganizationCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedProlonged PregnancyFrance
-
University Hospital, ToursCompleted
-
Technische Universität DresdenWithdrawnPregnancy Trimester, Second | Pregnancy Trimester, First | Pregnancy Trimester, ThirdGermany
-
Turku University HospitalUniversity of TurkuCompleted
-
Universitair Ziekenhuis BrusselMerck Serono International SAUnknownPregnancy | Pregnancy LossBelgium
-
Hopital Antoine BeclereUnknown
Clinical Trials on nutrition counseling
-
University of Alabama at BirminghamCompletedHead and Neck Cancer | Laryngeal Cancer | Pharyngeal CancerUnited States
-
University of CalgaryCompleted
-
University of Alabama at BirminghamAmerican Institute for Cancer ResearchCompletedHead and Neck Cancer | Laryngeal Cancer | Pharyngeal CancerUnited States
-
University of Alabama, TuscaloosaAcademy of Nutrition and DieteticsRecruitingBrain InjuriesUnited States
-
Harokopio UniversityState Scholarships Foundation, Athens, GreeceCompletedRheumatoid ArthritisGreece
-
Persephone BiosciencesKroger HealthRecruitingImpact of Dietary Chages Directed by Medical Nutrition Therapy on Gut Microbiome CompositionUnited States
-
Taipei Medical UniversityCompletedCerebrovascular DiseaseTaiwan
-
Ege UniversityCompletedMalnutrition | Stroke, Acute | Old Age; DebilityTurkey
-
Wageningen UniversityCompleted
-
Orotta College of Medicine and Health SciencesCompletedPregnancy Nutritional DiseaseEritrea