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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419211
• Other study ID #: A06-B25-06A
• Status: Completed
• Phase: Phase 0
• First received: January 4, 2007
• Last updated: May 23, 2012
• Start date: January 2007

Study information

• Verified date: May 2012
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Pregnancy

Intervention

Behavioral:
• Exercise
Tailored exercise program

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level		post-intervention and 3 months after felivery	No
Primary	Depressed Mood		post-intervention and 3 months following delivery	No
Primary	Health related quality of life		post-intervention and 3 months following delivery	No
Secondary	state anxiety		post-intervention and 3 months following delivery	No
Secondary	sleep quality		post-intervention and 3 months following delivery	No
Secondary	fatigue levels		post-intervention and 3 months following delivery	No
Secondary	exercise stage of change		post-intervention and 3 months following delivery	No
Secondary	self-efficacy for exercise		post-intervention and 3 months following delivery	No
Secondary	social support for exercise		post-intervention and 3 months following delivery	No