PregnancyInterGOFITNCT01610323
Fitness Improvement in Obese, Pregnant Women: an Intervention Trial
A study testing Exercise intervention in people with Pregnancy and Obesity, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obesity, Physical Activity
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women 18 years or older
- single pregnancy
- delivery at Centre Hospitalier Universitaire de Québec
- pre-pregnancy BMI ≥30 kg/m2
Who cannot join
- multiple pregnancy
- diabetes or chronic hypertension prior to pregnancy
- uncontrolled thyroid problems
- exercise contraindications
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1V 4G2
About this study
Official title: Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)
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.
- Conditions
- Pregnancy, Obesity, Physical Activity
- Being tested
- Exercise intervention, Standard Care
- Keywords
- Pregnancy, Obesity, Physical activity, Cardiorespiratory fitness, Muscular Fitness, Weight gain, Fetal growth
- Medical subject headings
- Obesity, Motor Activity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Physical activity 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 CareOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Exercise intervention Receives: Other: Exercise intervention |
| Control group | Other | Standard care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly time spent at physical activity of moderate intensity and above
Accelerometry data (minutes per week spent over selected cutpoints)
Measured: At 36 weeks of gestation
Secondary outcomes (6)
Gestational weight gain
Weight in kg at 36 weeks - weight in kg at 14 weeks
Measured: At 36 weeks of gestation
Muscular fitness
Endurance and strength of lower and upper limbs as assessed by an isokinetic dynamometer.
Measured: At 28 wks of gestation
Cardiorespiratory fitness
O2 consumption (ml*kg-1*min-1) at the anaerobic threshold.
Measured: At 28 weeks of gestation
Energy Expenditure
According to the Pregnancy Physical Activity Questionnaire (PPAQ)
Measured: At 36 weeks of gestation
Neonatal anthropometry
Birth weight, length and skinfolds
Measured: At delivery
Fetal growth
Ultrasound and doppler
Measured: At 28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of the Stars
- Responsible party
- Sponsor
- Investigators
- Isabelle Marc, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Québec (CHUQ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610323
- Sponsor's protocol ID
- SC11-05-021-21
- Acronym
- InterGOFIT
- Status last verified
- Jul 2014
- First submitted
- 31 May 2012
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness Improvement in Obese, Pregnant Women: an Intervention Trial (InterGOFIT)
- ClinicalTrials.gov ID
- NCT01610323
- Acronym / sponsor ID
- InterGOFIT / SC11-05-021-21
- Conditions
- Pregnancy, Obesity, Physical Activity
- Keywords
- Pregnancy, Obesity, Physical activity, Cardiorespiratory fitness, Muscular Fitness, Weight gain, Fetal growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Foundation of the Stars
- Study start
- Oct 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise interventionExercise intervention |
| Control group | Other | Other: Standard CareStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- pregnant women 18 years or older
- single pregnancy
- delivery at Centre Hospitalier Universitaire de Québec
- pre-pregnancy BMI ≥30 kg/m2
Key exclusion criteria (4 listed)
- multiple pregnancy
- diabetes or chronic hypertension prior to pregnancy
- uncontrolled thyroid problems
- exercise contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionAlso: Physical activity interventionExercise 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 | Exercise group |
| Standard Care | Other | Control group |
Primary outcome
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)
6 secondary outcomes
Gestational weight gain
Time frame: At 36 weeks of gestation
Muscular fitness
Time frame: At 28 wks of gestation
Cardiorespiratory fitness
Time frame: At 28 weeks of gestation
Energy Expenditure
Time frame: At 36 weeks of gestation
Neonatal anthropometry
Time frame: At delivery
Fetal growth
Time frame: At 28 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Derived from this study: PubMed 26375471Bisson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Marc, MD, PhD principal investigator
Centre Hospitalier Universitaire de Québec (CHUQ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Pregnancy and Obesity, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly time spent at physical activity of moderate intensity and above (time frame: At 36 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01610323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.