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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00419211
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
Deborah Da Costa, McGill University

Brief Summary:
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.

Condition or disease Intervention/treatment Phase
Pregnancy Depression Behavioral: Exercise Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: "Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
Study Start Date : January 2007
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lifestyle counseling
Tailored exercise program
Behavioral: Exercise
Tailored exercise program
No Intervention: No Intervention
Usual care group

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00419211

Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University
Principal Investigator: Deborah Da Costa, PhD McGill University

Responsible Party: Deborah Da Costa, Associate Professor, McGill University Identifier: NCT00419211     History of Changes
Other Study ID Numbers: A06-B25-06A
First Posted: January 8, 2007    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Deborah Da Costa, McGill University:
Pregnancy, Exercise, Depression

Additional relevant MeSH terms:
Behavioral Symptoms