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

NCT02180152 | Withdrawn

• 1 other identifier: Caminhadas2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Gestational Diabetes; Preeclampsia

Keywords

Perinatal outcomes

Outcome Measures

Primary Outcomes (1)

• Weight gain after postprandial walks in obese pregnant women.

  8 weeks

Study Arms (2)

Postprandial walk

EXPERIMENTAL

Behavioral: Postprandial walks

sedentary pregnant women

NO INTERVENTION

Interventions

Postprandial walks 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.

Postprandial walk

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Diabetes, Gestational; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Joao GB Alves, PhD

  Instituto de Medicina Integral Professor Fernando Figueira

  STUDY DIRECTOR

• Isabelle EA Pontes, Master

  Instituto de Medicina Integral Prof. Fernando Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

BR (1)