The Effect of Exercise on Preventing PostPartum Depression
|ClinicalTrials.gov Identifier: NCT00961402|
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : July 29, 2016
Last Update Posted : September 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|PostPartum Depression||Behavioral: Wellness Control Behavioral: Exercise Intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of an Exercise Intervention for the Prevention of PostPartum Depression|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Wellness Control
Participants will receive health and wellness information and no exercise information.
Behavioral: Wellness Control
6-month wellness control
Experimental: Exercise Intervention
Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.
Behavioral: Exercise Intervention
6 month exercise intervention
- Structured Clinical Interview for DSM-IV Axis I Disorders [ Time Frame: 6 months ]This measure was used to determine if participants met the diagnostic criteria for postpartum depression. This is a yes/no diagnostic tool and our data indicate percentage who meet criteria for depression.
- 7-Day Physical Activity Recall Interview [ Time Frame: 6 months ]Physical activity during previous 7 days. This measure does not have a range given it is directly dependent upon number of minutes of physical activity per week. The intensity ranges from moderate (similar to a brisk walk), hard (similar to a jog), and very hard (similar to a run).
- Edinburgh Postnatal Depression Scale [ Time Frame: 6 Months ]This scale is a continuous measure of postpartum depression. Range is 0-30 and a score of 10 or above may be considered depressed. Higher scores indicate higher depression.
- PHQ-9 [ Time Frame: 6 Months ]Continuous measure of depression. Scoring is on a scale of 0-27 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961402
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Beth A Lewis, PhD||University of Minnesota - Clinical and Translational Science Institute|