NCT01610323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

May 31, 2012

Last Update Submit

July 25, 2014

Conditions

PregnancyObesityPhysical Activity

Keywords

PregnancyObesityPhysical activityCardiorespiratory fitnessMuscular FitnessWeight gainFetal growth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Gestational weight gain

    At 36 weeks of gestation

  • Muscular fitness

    At 28 wks of gestation

  • Cardiorespiratory fitness

    At 28 weeks of gestation

  • Energy Expenditure

    At 36 weeks of gestation

  • Neonatal anthropometry

    At delivery

  • +1 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise intervention

Other: Exercise intervention

Control group

OTHER

Standard care

Other: Standard Care

Interventions

Exercise interventionOTHER

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
Exercise group
Standard CareOTHER
Control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women 18 years or older
  • single pregnancy
  • delivery at Centre Hospitalier Universitaire de Québec
  • pre-pregnancy BMI ≥30 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26375471DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityWeight Gain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Isabelle Marc, MD, PhD

    Centre Hospitalier Universitaire de Québec (CHUQ)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

CA(1)