CClinicalTrials.gg
CompletedNCT01610323InterGOFITUpdated Jul 28, 2014

Fitness Improvement in Obese, Pregnant Women: an Intervention Trial

An interventional study of Exercise intervention and Standard Care in Pregnancy, Obesity and Physical Activity, sponsored by CHU de Quebec-Universite Laval. Completed at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-28.

Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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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Conditions studied

  • Pregnancy
  • Obesity
  • Physical Activity

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Keywords

  • Pregnancy
  • Obesity
  • Physical activity
  • Cardiorespiratory fitness
  • Muscular Fitness
  • Weight gain
  • Fetal growth
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • multiple pregnancy
  • diabetes or chronic hypertension prior to pregnancy
  • uncontrolled thyroid problems
  • exercise contraindications
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Exercise group

    Exercise intervention

    Other: Exercise intervention

  • Other
    Control group

    Standard care

    Other: Standard Care

Interventions

  • OtherExercise 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.

    Also known as: Physical activity intervention

  • OtherStandard Care
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What researchers measure

Primary outcomes

  1. Weekly time spent at physical activity of moderate intensity and above

    Accelerometry data (minutes per week spent over selected cutpoints)

    Time frame: At 36 weeks of gestation

Secondary outcomes

  1. Gestational weight gain

    Weight in kg at 36 weeks - weight in kg at 14 weeks

    Time frame: At 36 weeks of gestation

  2. Muscular fitness

    Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.

    Time frame: At 28 wks of gestation

  3. Cardiorespiratory fitness

    O2 consumption (ml\*kg-1\*min-1) at the anaerobic threshold.

    Time frame: At 28 weeks of gestation

  4. Energy Expenditure

    According to the Pregnancy Physical Activity Questionnaire (PPAQ)

    Time frame: At 36 weeks of gestation

  5. Neonatal anthropometry

    Birth weight, length and skinfolds

    Time frame: At delivery

  6. Fetal growth

    Ultrasound and doppler

    Time frame: At 28 weeks of gestation

07

Study locations

1 site
  • Centre Hospitalier Universitaire de Québec
    Quebec, G1V 4G2, Canada
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References and documents

Publications

  • 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. PubMed 26375471 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01610323
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
Foundation of the Stars
Responsible party
Sponsor
First posted
Jun 4, 2012
Start date
Oct 2011
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Jul 28, 2014

Study contacts

Isabelle Marc, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Québec (CHUQ)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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