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

May 23, 2012 updated by: Deborah Da Costa, McGill University

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

76

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical Activity Level
Time Frame: post-intervention and 3 months after felivery
post-intervention and 3 months after felivery
Depressed Mood
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
Health related quality of life
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
state anxiety
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
sleep quality
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
fatigue levels
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
exercise stage of change
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
self-efficacy for exercise
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery
social support for exercise
Time Frame: post-intervention and 3 months following delivery
post-intervention and 3 months following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Deborah Da Costa, PhD, McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

May 25, 2012

Last Update Submitted That Met QC Criteria

May 23, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A06-B25-06A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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