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

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

Detailed Description
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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.

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

Conditions
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Pregnancy, Depression

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Tailored exercise program | Behavioral: Exercise<br>* Tailored exercise program<br>|
| No Intervention: No Intervention<br>Usual care group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Exercise, Depression