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Completed

NCT Number: NCT00419211

An Intervention Study 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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Tailored exercise program

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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

"Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy

Important dates

Study start
2007
Primary completion
2011
First posted
Jan 8, 2007
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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