Depression Clinical Trial
Official title:
"Fit Pregnancy": A Transtheoretical-Model Based Intervention Designed To Increase Physical Activity and Maternal Well-Being During Pregnancy
NCT number | NCT00419211 |
Other study ID # | A06-B25-06A |
Secondary ID | |
Status | Completed |
Phase | Phase 0 |
First received | January 4, 2007 |
Last updated | May 23, 2012 |
Start date | January 2007 |
Verified date | May 2012 |
Source | McGill University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
To refine, implement and evaluate a motivationally-tailored exercise intervention for increasing physical activity and mental health during pregnancy and the postpartum.
Status | Completed |
Enrollment | 76 |
Est. completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University |
Canada,
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 |
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