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Trial record 6 of 264 for:    Postpartum Depression AND Postpartum Depression | "Depression" AND "Depression"

The Effect of Exercise on Preventing PostPartum Depression

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ClinicalTrials.gov Identifier: NCT00961402
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : July 29, 2016
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition PostPartum Depression
Interventions Behavioral: Wellness Control
Behavioral: Exercise Intervention
Enrollment 130

Recruitment Details 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 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.
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description

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

Exercise: 6-month exercise intervention vs. wellness control

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

Period Title: Overall Study
Started 64 66
Randomized 64 66
Completed 63 61
Not Completed 1 5
Arm/Group Title Wellness Control Exercise Total
Hide Arm/Group Description

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

Exercise: 6-month exercise intervention vs. wellness control

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 of all reporting groups
Overall Number of Baseline Participants 64 66 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 66 participants 130 participants
31.39  (4.63) 31.69  (5.27) 31.54  (4.95)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Females Number Analyzed 64 participants 66 participants 130 participants
64 66 130
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Hispanic or Latino
3
   4.7%
2
   3.0%
5
   3.8%
Not Hispanic or Latino
61
  95.3%
64
  97.0%
125
  96.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
American Indian or Alaska Native
0
   0.0%
2
   3.0%
2
   1.5%
Asian
4
   6.3%
1
   1.5%
5
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   4.7%
6
   9.1%
9
   6.9%
White
55
  85.9%
55
  83.3%
110
  84.6%
More than one race
2
   3.1%
2
   3.0%
4
   3.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 66 participants 130 participants
64 66 130
Perceived Stress Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 66 participants 130 participants
24.73  (6.98) 23.21  (7.94) 23.96  (7.50)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 66 participants 130 participants
6.56  (4.27) 5.42  (3.28) 5.99  (3.83)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 66 participants 130 participants
7.11  (3.08) 7.11  (2.61) 7.11  (2.84)
[1]
Measure Description: This measure assesses sleep problems. This 9-item measure ranges from 0-21 with higher scores indicating more sleep problems.
1.Primary Outcome
Title Structured Clinical Interview for DSM-IV Axis I Disorders
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description:

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

Exercise: 6-month exercise intervention vs. wellness control

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

Overall Number of Participants Analyzed 63 61
Measure Type: Number
Unit of Measure: percentage of participants
7.94 8.20
2.Secondary Outcome
Title 7-Day Physical Activity Recall Interview
Hide Description 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).
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description:

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

Exercise: 6-month exercise intervention vs. wellness control

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

Overall Number of Participants Analyzed 63 61
Mean (Standard Deviation)
Unit of Measure: Number of physical activity minutes
123.3  (111.4) 129.8  (87.5)
3.Secondary Outcome
Title Edinburgh Postnatal Depression Scale
Hide Description 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.
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description:

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

Exercise: 6-month exercise intervention vs. wellness control

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

Overall Number of Participants Analyzed 63 61
Mean (Standard Deviation)
Unit of Measure: Score on a scale
7.02  (4.64) 4.69  (3.89)
4.Secondary Outcome
Title PHQ-9
Hide Description 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
Time Frame 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description:

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

Exercise: 6-month exercise intervention vs. wellness control

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

Overall Number of Participants Analyzed 63 61
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.22  (4.59) 3.08  (3.04)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wellness Control Exercise
Hide Arm/Group Description

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

Exercise: 6-month exercise intervention vs. wellness control

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

All-Cause Mortality
Wellness Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wellness Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/66 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wellness Control Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/130 (0.00%)   0/130 (0.00%) 
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
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00961402     History of Changes
Other Study ID Numbers: R21MH085176 ( U.S. NIH Grant/Contract )
R21MH085176 ( U.S. NIH Grant/Contract )
First Submitted: August 18, 2009
First Posted: August 19, 2009
Results First Submitted: November 11, 2015
Results First Posted: July 29, 2016
Last Update Posted: September 15, 2016