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

NCT ID: NCT02180152

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Gestational Diabetes Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Postprandial walk

Group Type EXPERIMENTAL

Postprandial walks

Intervention Type BEHAVIORAL

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.

sedentary pregnant women

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Postprandial walks

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Professor Fernando Figueira Integral Medicine Institute

OTHER

Sponsor Role lead

Responsible Party

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João Guilherme Bezerra Alves

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joao GB Alves, PhD

Role: STUDY_DIRECTOR

Instituto de Medicina Integral Professor Fernando Figueira

Isabelle EA Pontes, Master

Role: PRINCIPAL_INVESTIGATOR

Instituto de Medicina Integral Prof. Fernando Figueira

Locations

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Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.imip.org.br

Click here for more informations about the Instituto de Medicina Integral Professor Fernando Figueira

Other Identifiers

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Caminhadas2014

Identifier Type: -

Identifier Source: org_study_id

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