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The Effect of Exercise on Preventing PostPartum Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00961402
First received: August 18, 2009
Last updated: August 3, 2016
Last verified: August 2016
Results First Received: November 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: PostPartum Depression
Interventions: Behavioral: Wellness Control
Behavioral: Exercise Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from January, 2010 through May, 2011 and follow-up assessments were completed by November, 2011. Participants were recruited via advertisements to the general public.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The major reason for why participants who consented but did not participate was that they failed to return our telephone calls after they had their baby or we were unable to obtain physician consent for them to participate.

Reporting Groups
  Description
Wellness Control

Participants will receive health and wellness information and no exercise information.

Exercise: 6-month exercise intervention vs. wellness control

Exercise

Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.

Exercise: 6-month exercise intervention vs. wellness control


Participant Flow:   Overall Study
    Wellness Control   Exercise
STARTED   64   66 
Randomized   64   66 
COMPLETED   63   61 
NOT COMPLETED   1   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Wellness Control

Participants will receive health and wellness information and no exercise information.

Exercise: 6-month exercise intervention vs. wellness control

Exercise

Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.

Exercise: 6-month exercise intervention vs. wellness control

Total Total of all reporting groups

Baseline Measures
   Wellness Control   Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   66   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.39  (4.63)   31.69  (5.27)   31.54  (4.95) 
Gender, Customized 
[Units: Participants]
     
Females   64   66   130 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   61   64   125 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   2   2 
Asian   4   1   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   6   9 
White   55   55   110 
More than one race   2   2   4 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   64   66   130 
Perceived Stress Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 24.73  (6.98)   23.21  (7.94)   23.96  (7.50) 
[1] This scale measures the participant's perception of stress. This is a 14 item scale ranging from 0-56, with higher scores indicating higher stress.
Patient Health Questionnaire (PHQ-9) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.56  (4.27)   5.42  (3.28)   5.99  (3.83) 
[1] This measure assess depressive symptoms. There are 9 items and scores range from 0-27 with higher scores indicating higher levels of depression.
Pittsburgh Sleep Quality Index [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 7.11  (3.08)   7.11  (2.61)   7.11  (2.84) 
[1] This measure assesses sleep problems. This 9-item measure ranges from 0-21 with higher scores indicating more sleep problems.


  Outcome Measures
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1.  Primary:   Structured Clinical Interview for DSM-IV Axis I Disorders   [ Time Frame: 6 months ]

2.  Secondary:   7-Day Physical Activity Recall Interview   [ Time Frame: 6 months ]

3.  Secondary:   Edinburgh Postnatal Depression Scale   [ Time Frame: 6 Months ]

4.  Secondary:   PHQ-9   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Beth Lewis
Organization: University of Minnesota
phone: 612-625-0756
e-mail: blewis@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00961402     History of Changes
Other Study ID Numbers: R21MH085176 ( US NIH Grant/Contract Award Number )
Study First Received: August 18, 2009
Results First Received: November 11, 2015
Last Updated: August 3, 2016
Health Authority: United States: Federal Government