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

Early Phase 1

Completed

• Conditions: Pregnancy; Depression
• Interventions: Behavioral: Exercise

• Registration Number: NCT00419211
• Lead Sponsor: McGill University

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-04
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-08
• Primary Completion: 2011-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Exercise	Tailored exercise program

Primary Outcome Measures

Name	Time	Method
Physical Activity Level	post-intervention and 3 months after felivery
Depressed Mood	post-intervention and 3 months following delivery
Health related quality of life	post-intervention and 3 months following delivery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada