Fitness Improvement in Obese, Pregnant Women: an Intervention Trial

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Pregnancy, Obesity, Physical Activity

Intervention / Treatment
-----------------
* Other: Exercise intervention
* Other: Standard Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>Exercise intervention | Other: Exercise intervention<br>* 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.<br>* Other names: Physical activity intervention;|
| Other: Control group<br>Standard care | Other: Standard Care<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Obesity, Physical activity, Cardiorespiratory fitness, Muscular Fitness, Weight gain, Fetal growth