Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deborah Da Costa, McGill University
ClinicalTrials.gov Identifier:
NCT00419211
First received: January 4, 2007
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Pregnancy
Depression
Behavioral: Exercise
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Physical Activity Level [ Time Frame: post-intervention and 3 months after felivery ] [ Designated as safety issue: No ]
  • Depressed Mood [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • state anxiety [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • sleep quality [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • fatigue levels [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • exercise stage of change [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • self-efficacy for exercise [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]
  • social support for exercise [ Time Frame: post-intervention and 3 months following delivery ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: January 2007
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Tailored exercise program
Behavioral: Exercise
Tailored exercise program
No Intervention: No Intervention
Usual care group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419211

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

No publications provided

Responsible Party: Deborah Da Costa, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT00419211     History of Changes
Other Study ID Numbers: A06-B25-06A
Study First Received: January 4, 2007
Last Updated: May 23, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University:
Pregnancy, Exercise, Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014