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CompletedNCT00419211Updated May 25, 2012

An Intervention Study to Increase Physical Activity and Maternal Well-being During Pregnancy

An Early Phase 1 interventional study of Exercise in Pregnancy and Depression, sponsored by McGill University. Completed at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-25.

Sponsored by McGill University · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnancy
  • Depression

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Keywords

  • Pregnancy, Exercise, Depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 76 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pregnant

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Lifestyle counseling

    Tailored exercise program

    Behavioral: Exercise

  • No intervention
    No Intervention

    Usual care group

Interventions

  • BehavioralExercise

    Tailored exercise program

06

What researchers measure

Primary outcomes

  1. Physical Activity Level

    Time frame: post-intervention and 3 months after felivery

  2. Depressed Mood

    Time frame: post-intervention and 3 months following delivery

  3. Health related quality of life

    Time frame: post-intervention and 3 months following delivery

Secondary outcomes

  1. state anxiety

    Time frame: post-intervention and 3 months following delivery

  2. sleep quality

    Time frame: post-intervention and 3 months following delivery

  3. fatigue levels

    Time frame: post-intervention and 3 months following delivery

  4. exercise stage of change

    Time frame: post-intervention and 3 months following delivery

  5. self-efficacy for exercise

    Time frame: post-intervention and 3 months following delivery

  6. social support for exercise

    Time frame: post-intervention and 3 months following delivery

07

Study locations

1 site
  • McGill University Health Centre
    Montreal, Quebec H3A 1A1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00419211
Lead sponsor
McGill University
Responsible party
Deborah Da Costa (Associate Professor, McGill University) — Principal investigator
First posted
Jan 8, 2007
Start date
Jan 2007
Primary completion
Dec 2011
Last update
May 25, 2012

Study contacts

Deborah Da Costa, PhD
principal investigator · McGill University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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