Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)

Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)

In pregnancy, the adoption or pursuit of a sedentary lifestyle contributes to the development of co-morbid conditions such as hypertension, maternal and childhood obesity, gestational diabetes, pre-eclampsia, cesarean section and delivery of large-for-gestational-age infants (LGA).

The aim of this study is to test the hypothesis that obese, pregnant women following a supervised moderate intensity physical conditioning program during the 2nd trimester of pregnancy will maintain a higher level of physical activity up to the end of pregnancy, as compared to women in the control group. We will also conduct a pilot study on the feasibility to examine the effects of the intervention on maternal fitness and neonatal anthropometry.

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity; Pregnancy
• Intervention / Treatment: Other: Standard Care; Other: Exercise intervention

Detailed Description

Looking at the multiple needs of pregnant women with obesity, physical conditioning may offer a great opportunity to improve fitness and to decrease cardio-metabolic disturbances, to prevent excessive weight gain, to improve general health status, and to reduce health care utilization. Furthermore, beneficial effects of fitness on adverse maternal health outcomes related to obesity might decrease the development of long-term obesity and metabolic repercussions in the offspring.

The Society of Obstetricians and Gynaecologists of Canada (SOGC) recommends that all women without contraindication be encouraged to participate in aerobic and strength-conditioning exercises as part of a healthy lifestyle during pregnancy. Despite these recommendations, obese women are inactive during pregnancy and are currently still at high risk of poor physical fitness.

Thus, although exercise clearly improves maternal health status and thus potentially prevents adverse perinatal outcomes, obese pregnant women poorly adhere to experts' recommendations about the need for exercise during pregnancy. Therefore, this situation justifies the need to develop adapted strategies aimed at increasing the implementation of guideline recommendations in this population.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Centre Hospitalier Universitaire de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant women 18 years or older
• single pregnancy
• delivery at Centre Hospitalier Universitaire de Québec
• pre-pregnancy BMI ≥30 kg/m2

Exclusion Criteria:

• multiple pregnancy
• diabetes or chronic hypertension prior to pregnancy
• uncontrolled thyroid problems
• exercise contraindications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise group; Exercise intervention	Other: Exercise intervention; Exercise group: 12 weeks of moderate intensity physical training under individual supervision in a specialised conditioning center, with a goal of 3 1h-sessions/week (from 16 wks to 28 wks of gestation). Including aerobic and muscular training.; Other Names: Physical activity intervention
OTHER: Control group; Standard care	Other: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly time spent at physical activity of moderate intensity and above	Accelerometry data (minutes per week spent over selected cutpoints)	At 36 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain	Weight in kg at 36 weeks - weight in kg at 14 weeks	At 36 weeks of gestation
Muscular fitness	Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.	At 28 wks of gestation
Cardiorespiratory fitness	O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.	At 28 weeks of gestation
Energy Expenditure	According to the Pregnancy Physical Activity Questionnaire (PPAQ)	At 36 weeks of gestation
Neonatal anthropometry	Birth weight, length and skinfolds	At delivery
Fetal growth	Ultrasound and doppler	At 28 weeks of gestation

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Foundation of the Stars
• Investigators: Principal Investigator: Isabelle Marc, MD, PhD, Centre Hospitalier Universitaire de Quebec (CHUQ)

Publications and helpful links

General Publications

• Bisson M, Almeras N, Dufresne SS, Robitaille J, Rheaume C, Bujold E, Frenette J, Tremblay A, Marc I. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study. PLoS One. 2015 Sep 16;10(9):e0137742. doi: 10.1371/journal.pone.0137742. eCollection 2015.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (ESTIMATE): June 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Pregnancy; Physical activity; Cardiorespiratory fitness; Weight gain; Fetal growth; Muscular Fitness
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: SC11-05-021-21