Fitness Improvement in Obese, Pregnant Women: an Intervention Trial

Obesity Clinical Trial

— InterGOFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610323
• Other study ID #: SC11-05-021-21
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: July 25, 2014
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Physical Activity
• Pregnancy

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.
• Standard Care

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec	Fondation des étoiles

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly time spent at physical activity of moderate intensity and above	Accelerometry data (minutes per week spent over selected cutpoints)	At 36 weeks of gestation	No
Secondary	Gestational weight gain	Weight in kg at 36 weeks - weight in kg at 14 weeks	At 36 weeks of gestation	No
Secondary	Muscular fitness	Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.	At 28 wks of gestation	No
Secondary	Cardiorespiratory fitness	O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.	At 28 weeks of gestation	No
Secondary	Energy Expenditure	According to the Pregnancy Physical Activity Questionnaire (PPAQ)	At 36 weeks of gestation	No
Secondary	Neonatal anthropometry	Birth weight, length and skinfolds	At delivery	No
Secondary	Fetal growth	Ultrasound and doppler	At 28 weeks of gestation	No