Clinical trial NCT00419211: An Intervention Study to Increase Physical Activity and Maternal Well-being During Pregnancy
Official title: "Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pregnancy
Depression
Keywords: Pregnancy, Exercise, Depression
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Activity Level
timeFrame: post-intervention and 3 months after felivery
measure: Depressed Mood
timeFrame: post-intervention and 3 months following delivery
measure: Health related quality of life
timeFrame: post-intervention and 3 months following delivery
Secondary outcomes:
measure: state anxiety
timeFrame: post-intervention and 3 months following delivery
measure: sleep quality
timeFrame: post-intervention and 3 months following delivery
measure: fatigue levels
timeFrame: post-intervention and 3 months following delivery
measure: exercise stage of change
timeFrame: post-intervention and 3 months following delivery
measure: self-efficacy for exercise
timeFrame: post-intervention and 3 months following delivery
measure: social support for exercise
timeFrame: post-intervention and 3 months following delivery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Deborah Da Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: