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

This study is currently recruiting participants.
Verified May 2012 by Centre Hospitalier Universitaire de Québec, CHU de Québec
Sponsor:
Collaborator:
Fondation des étoiles
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01610323
First received: May 31, 2012
Last updated: June 1, 2012
Last verified: May 2012
  Purpose

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 Intervention
Pregnancy
Obesity
Physical Activity
Other: Exercise intervention
Other: Usual activities

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Weekly time spent at physical activity of moderate intensity and above [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]
    Accelerometry data (minutes per week spent over selected cutpoints)


Secondary Outcome Measures:
  • Gestational weight gain [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]
    Weight in kg at 36 weeks - weight in kg at 14 weeks

  • Muscular fitness [ Time Frame: At 28 wks of gestation ] [ Designated as safety issue: No ]
    Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.

  • Cardiorespiratory fitness [ Time Frame: At 28 weeks of gestation ] [ Designated as safety issue: No ]
    O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.

  • Energy Expenditure [ Time Frame: At 36 weeks of gestation ] [ Designated as safety issue: No ]
    According to the Pregnancy Physical Activity Questionnaire (PPAQ)

  • Neonatal anthropometry [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Birth weight, length and skinfolds

  • Fetal growth [ Time Frame: At 28 weeks of gestation ] [ Designated as safety issue: No ]
    Ultrasound and doppler


Estimated Enrollment: 44
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise group 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
No Intervention: Control group Other: Usual activities
Control group

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01610323

Contacts
Contact: Michèle Bisson, BSc 418-656-4141 ext 46008 michele.bisson@crchuq.ulaval.ca
Contact: Isabelle Marc, MD, Ph.D 418-656-4141 ext 46350 isabelle.marc@crchul.ulaval.ca

Locations
Canada
Centre Hospitalier Universitaire de Québec Recruiting
Quebec, Canada, G1V 4G2
Contact: Michèle Bisson    418-656-4141 ext 46008      
Principal Investigator: Isabelle Marc, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Fondation des étoiles
Investigators
Principal Investigator: Isabelle Marc, MD, PhD Centre Hospitalier Universitaire de Québec (CHUQ)
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01610323     History of Changes
Other Study ID Numbers: SC11-05-021-21
Study First Received: May 31, 2012
Last Updated: June 1, 2012
Health Authority: Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Pregnancy
Obesity
Physical activity
Cardiorespiratory fitness
Muscular Fitness
Weight gain
Fetal growth

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014