Clinical trial NCT01610323: Fitness Improvement in Obese, Pregnant Women: an Intervention Trial
Official title: Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Obesity
Physical Activity
Keywords: Pregnancy
Obesity
Physical activity
Cardiorespiratory fitness
Muscular Fitness
Weight gain
Fetal growth
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Foundation of the Stars
First posted: 2012-06-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Weekly time spent at physical activity of moderate intensity and above
timeFrame: At 36 weeks of gestation
Secondary outcomes:
measure: Gestational weight gain
timeFrame: At 36 weeks of gestation
measure: Muscular fitness
timeFrame: At 28 wks of gestation
measure: Cardiorespiratory fitness
timeFrame: At 28 weeks of gestation
measure: Energy Expenditure
timeFrame: At 36 weeks of gestation
measure: Neonatal anthropometry
timeFrame: At delivery
measure: Fetal growth
timeFrame: At 28 weeks of gestation
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
Study officials:
affiliation: Centre Hospitalier Universitaire de Québec (CHUQ)
name: Isabelle Marc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.