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Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial

Primary Purpose

Obesity, Gestational Diabetes, Preeclampsia

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Postprandial walks
Sponsored by
Professor Fernando Figueira Integral Medicine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Perinatal outcomes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 40 years;
  • Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan;
  • Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study;
  • Physically inactive - according to the International Physical Activity Questionnaire (IPAC);
  • Single pregnancy.

Exclusion Criteria:

  • Kidney disease or collagen;
  • Previous history of GDM;
  • Diabetes type 1 or type 2;
  • Hypertensive disorders related to pregnancy;
  • Hemodynamic instability;
  • Vaginal bleeding;
  • Visual, auditory or cognitive impairment.

Sites / Locations

  • Instituto de Medicina Integral Professor Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Postprandial walk

sedentary pregnant women

Arm Description

Outcomes

Primary Outcome Measures

Weight gain after postprandial walks in obese pregnant women.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2014
Last Updated
July 21, 2020
Sponsor
Professor Fernando Figueira Integral Medicine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02180152
Brief Title
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial
Official Title
Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Professor Fernando Figueira Integral Medicine Institute

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to verify if postprandial walks are effective in obese pregnant women, as regards to gestational weight gain and typical diseases of that period, as gestational diabetes and preeclampsia. Perinatal outcomes will be observed, such as macrosomia, shoulder dystocia and fetal death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gestational Diabetes, Preeclampsia
Keywords
Perinatal outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postprandial walk
Arm Type
Experimental
Arm Title
sedentary pregnant women
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Postprandial walks
Intervention Description
Obese pregnant women will be target to carry out walks lasting 10' after the main meals (breakfast, lunch and dinner), Monday to Friday, during 8 weeks. Adherence to the program will be determined by daily readings of pedometers previously provided to pregnant women; minimum of 1500 steps per day from Monday to Friday.
Primary Outcome Measure Information:
Title
Weight gain after postprandial walks in obese pregnant women.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 40 years; Gestational age ≤ 20 weeks, calculated from the last menstrual period and confirmed by the first ultrasound scan; Obesity - body mass index ( BMI ) ≥ 30 kg/m2, based on the weight before pregnancy, reported by pregnant women no more than 5 kg below measured at admission to the study; Physically inactive - according to the International Physical Activity Questionnaire (IPAC); Single pregnancy. Exclusion Criteria: Kidney disease or collagen; Previous history of GDM; Diabetes type 1 or type 2; Hypertensive disorders related to pregnancy; Hemodynamic instability; Vaginal bleeding; Visual, auditory or cognitive impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao GB Alves, PhD
Organizational Affiliation
Instituto de Medicina Integral Professor Fernando Figueira
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isabelle EA Pontes, Master
Organizational Affiliation
Instituto de Medicina Integral Prof. Fernando Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Medicina Integral Professor Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070-550
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.imip.org.br
Description
Click here for more informations about the Instituto de Medicina Integral Professor Fernando Figueira

Learn more about this trial

Postprandial Walking in Obese Pregnant Women and Perinatal Outcomes - a Multicenter Randomized Clinical Trial

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