"Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- McGill University
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- Physical Activity Level
Study Overview
Brief Summary
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Physical Activity Level
Time Frame: post-intervention and 3 months after felivery
Depressed Mood
Time Frame: post-intervention and 3 months following delivery
Health related quality of life
Time Frame: post-intervention and 3 months following delivery
Secondary Outcomes
- state anxiety(post-intervention and 3 months following delivery)
- sleep quality(post-intervention and 3 months following delivery)
- fatigue levels(post-intervention and 3 months following delivery)
- exercise stage of change(post-intervention and 3 months following delivery)
- self-efficacy for exercise(post-intervention and 3 months following delivery)
- social support for exercise(post-intervention and 3 months following delivery)
Investigators
Deborah Da Costa
Associate Professor
McGill University