The Effect of Exercise on Preventing PostPartum Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|