Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)
|ClinicalTrials.gov Identifier: NCT01610323|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : July 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Obesity Physical Activity||Other: Exercise intervention Other: Standard Care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
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
- Weekly time spent at physical activity of moderate intensity and above [ Time Frame: At 36 weeks of gestation ]Accelerometry data (minutes per week spent over selected cutpoints)
- Gestational weight gain [ Time Frame: At 36 weeks of gestation ]Weight in kg at 36 weeks - weight in kg at 14 weeks
- Muscular fitness [ Time Frame: At 28 wks of gestation ]Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.
- Cardiorespiratory fitness [ Time Frame: At 28 weeks of gestation ]O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.
- Energy Expenditure [ Time Frame: At 36 weeks of gestation ]According to the Pregnancy Physical Activity Questionnaire (PPAQ)
- Neonatal anthropometry [ Time Frame: At delivery ]Birth weight, length and skinfolds
- Fetal growth [ Time Frame: At 28 weeks of gestation ]Ultrasound and doppler
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610323
|Centre Hospitalier Universitaire de Québec|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Isabelle Marc, MD, PhD||Centre Hospitalier Universitaire de Québec (CHUQ)|