PregnancyEarly Phase 1NCT00419211
An Intervention Study to Increase Physical Activity and Maternal Well-being During Pregnancy
A Early Phase 1 study testing Exercise in people with Pregnancy and Depression, run by McGill University at 1 site in Canada.
Trial summary
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Depression
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Dec 2011
- Phase
- Early Phase 1
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant
Who cannot join
- Regular participation in moderate intensity exercise for at least 30 minutes, 3 or more times a week at the time of study entry
- Contraindications for participating in exercise during pregnancy as outlined by the SOGC/CSEP clinical practice guidelines
- Inability to communicate in either English or French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.
Read the detailed description
Pregnancy appears to pose a further barrier to exercise, as women remain inactive or cease to exercise all together. Yet, regular physical activity during pregnancy in healthy women has been shown to be safe and positively associated with physical and psychological health benefits. To date interventions to promote physical activity have not targeted pregnant women. We are proposing to pilot the first study to evaluate a theory-derived intervention designed to promote physical activity during pregnancy. We anticipate that pregnant women assigned to the motivationally-tailored exercise intervention will show a significant increase in physical activity from baseline at the post-treatment follow-up (32 weeks gestation). We expect that the motivationally-tailored intervention will positively influence physical and mental health status during pregnancy.
- Conditions
- Pregnancy, Depression
- Being tested
- Exercise
- Keywords
- Pregnancy, Exercise, Depression
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Tailored exercise program
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Tailored exercise program Receives: Behavioral: Exercise |
| No Intervention | No intervention | Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Measured: post-intervention and 3 months after felivery
Depressed Mood
Measured: post-intervention and 3 months following delivery
Health related quality of life
Measured: post-intervention and 3 months following delivery
Secondary outcomes (6)
state anxiety
Measured: post-intervention and 3 months following delivery
sleep quality
Measured: post-intervention and 3 months following delivery
fatigue levels
Measured: post-intervention and 3 months following delivery
exercise stage of change
Measured: post-intervention and 3 months following delivery
self-efficacy for exercise
Measured: post-intervention and 3 months following delivery
social support for exercise
Measured: post-intervention and 3 months following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Da Costa, McGill University
- Investigators
- Deborah Da Costa, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419211
- Sponsor's protocol ID
- A06-B25-06A
- Status last verified
- May 2012
- First submitted
- 4 Jan 2007
- Last updated
- 25 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
- ClinicalTrials.gov ID
- NCT00419211
- Acronym / sponsor ID
- A06-B25-06A
- Conditions
- Pregnancy, Depression
- Keywords
- Pregnancy, Exercise, Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (actual)
- First posted
- 8 Jan 2007 (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.
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.
Detailed description
Pregnancy appears to pose a further barrier to exercise, as women remain inactive or cease to exercise all together. Yet, regular physical activity during pregnancy in healthy women has been shown to be safe and positively associated with physical and psychological health benefits. To date interventions to promote physical activity have not targeted pregnant women. We are proposing to pilot the first study to evaluate a theory-derived intervention designed to promote physical activity during pregnancy. We anticipate that pregnant women assigned to the motivationally-tailored exercise intervention will show a significant increase in physical activity from baseline at the post-treatment follow-up (32 weeks gestation). We expect that the motivationally-tailored intervention will positively influence physical and mental health status during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: ExerciseTailored exercise program |
| No Intervention | No intervention | –Usual care group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant
Key exclusion criteria (3 listed)
- Regular participation in moderate intensity exercise for at least 30 minutes, 3 or more times a week at the time of study entry
- Contraindications for participating in exercise during pregnancy as outlined by the SOGC/CSEP clinical practice guidelines
- Inability to communicate in either English or French.
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 |
|---|---|---|
| ExerciseTailored exercise program | Behavioural | Lifestyle counseling |
Primary outcome
Physical Activity Level
Time frame: post-intervention and 3 months after felivery
Depressed Mood
Time frame: post-intervention and 3 months following delivery
Health related quality of life
Time frame: post-intervention and 3 months following delivery
6 secondary outcomes
state anxiety
Time frame: post-intervention and 3 months following delivery
sleep quality
Time frame: post-intervention and 3 months following delivery
fatigue levels
Time frame: post-intervention and 3 months following delivery
exercise stage of change
Time frame: post-intervention and 3 months following delivery
self-efficacy for exercise
Time frame: post-intervention and 3 months following delivery
social support for exercise
Time frame: post-intervention and 3 months following delivery
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 25 May 2012.
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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.
Deborah Da Costa, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exercise in people with Pregnancy and Depression, run by McGill University 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 1 inclusion and 3 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 25 May 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical Activity Level (time frame: post-intervention and 3 months after felivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2012.