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Completed

NCT Number: NCT01610323

Fitness Improvement in Obese, Pregnant Women: an Intervention Trial

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.

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Key information

Conditions

Pregnancy Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

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 names: Physical activity intervention

Standard care

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Foundation of the Stars

Registry information

Official study title

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

Acronym: InterGOFIT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2012
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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