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.
Other: Exercise intervention
Other: Standard Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)|
- Weekly time spent at physical activity of moderate intensity and above [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]Accelerometry data (minutes per week spent over selected cutpoints)
- Gestational weight gain [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]Weight in kg at 36 weeks - weight in kg at 14 weeks
- Muscular fitness [ Time Frame: At 28 wks of gestation ] [ Designated as safety issue: No ]Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.
- Cardiorespiratory fitness [ Time Frame: At 28 weeks of gestation ] [ Designated as safety issue: No ]O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.
- Energy Expenditure [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]According to the Pregnancy Physical Activity Questionnaire (PPAQ)
- Neonatal anthropometry [ Time Frame: At delivery ] [ Designated as safety issue: No ]Birth weight, length and skinfolds
- Fetal growth [ Time Frame: At 28 weeks of gestation ] [ Designated as safety issue: No ]Ultrasound and doppler
|Study Start Date:||October 2011|
|Study Completion Date:||July 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Exercise group
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 Name: Physical activity intervention
|Other: Standard Care|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610323
|Centre Hospitalier Universitaire de Québec|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Isabelle Marc, MD, PhD||Centre Hospitalier Universitaire de Québec (CHUQ)|