NCT02697981

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

February 3, 2016

Last Update Submit

April 4, 2019

Conditions

Pregnancy

Keywords

sleeve gastrectomy

Outcome Measures

Primary Outcomes (3)

  • Nutrient intake

    24 hour dietary intake and a questionaires on eating habits.

    at inclusion (Time 1),will be compared to recommendation for each individual

  • Nutrient intake

    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

    24 hour dietary intake and a questionaires on eating habits.

    gestational week 30 (time 3), will be compared to recommendation for each individual

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: nutrition counseling

control group

NO INTERVENTION

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.

Interventions

nutrition counselingBEHAVIORAL

nutrition counseling and guidance.

Also known as: follow-up
intervention group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Mc

Haifa, Israel

Location

Related Publications (8)

  • 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.

    PMID: 22325676BACKGROUND

  • 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.

    PMID: 20820939BACKGROUND

  • 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.

    PMID: 26205215BACKGROUND

  • 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.

    PMID: 22644802BACKGROUND

  • 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.

    PMID: 21126923BACKGROUND

  • 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.

    PMID: 25078533BACKGROUND

  • 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.

    PMID: 25699300BACKGROUND

  • 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.

    PMID: 34999322DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

March 3, 2016

Study Start

May 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

IL(1)