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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01610323
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : July 28, 2014
Foundation of the Stars
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Pregnancy Obesity Physical Activity Other: Exercise intervention Other: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

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 Name: Physical activity intervention

Control group
Standard care
Other: Standard Care

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Gestational weight gain [ Time Frame: At 36 weeks of gestation ]
    Weight in kg at 36 weeks - weight in kg at 14 weeks

  2. Muscular fitness [ Time Frame: At 28 wks of gestation ]
    Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.

  3. Cardiorespiratory fitness [ Time Frame: At 28 weeks of gestation ]
    O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.

  4. Energy Expenditure [ Time Frame: At 36 weeks of gestation ]
    According to the Pregnancy Physical Activity Questionnaire (PPAQ)

  5. Neonatal anthropometry [ Time Frame: At delivery ]
    Birth weight, length and skinfolds

  6. Fetal growth [ Time Frame: At 28 weeks of gestation ]
    Ultrasound and doppler

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01610323

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Centre Hospitalier Universitaire de Québec
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Foundation of the Stars
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Principal Investigator: Isabelle Marc, MD, PhD Centre Hospitalier Universitaire de Québec (CHUQ)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CHU de Quebec-Universite Laval Identifier: NCT01610323     History of Changes
Other Study ID Numbers: SC11-05-021-21
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by CHU de Quebec-Universite Laval:
Physical activity
Cardiorespiratory fitness
Muscular Fitness
Weight gain
Fetal growth