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Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression (HM2)

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: NCT01883479
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 29, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE April 24, 2013
First Posted Date  ICMJE June 21, 2013
Last Update Posted Date June 29, 2017
Study Start Date  ICMJE December 2012
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Depression [ Time Frame: 6 months ]
Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Depressive Symptoms [ Time Frame: 6 months ]
Depressive symptoms as assessed by the PHQ-9
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression
Official Title  ICMJE Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.
Brief Summary The purpose of this study is to examine the efficacy of the active interventions (exercise or wellness/support intervention) compared to usual care on the prevention of postpartum depression among women at risk for depression. The investigators will also examine the efficacy of an exercise intervention compared to a wellness/support intervention on postpartum depressive symptoms among women at risk for depression.
Detailed Description The purpose of this study is to examine the efficacy of exercise and wellness/support interventions for preventing postpartum depression. Specifically, 450 sedentary postpartum women (2-6 weeks postpartum) with a history of depression prior to pregnancy will be randomized to one of three groups each lasting six months: (1) telephone-based exercise intervention; (2) telephone-based wellness/support intervention; or (3) usual care. Participants will also complete a follow-up assessment session at 9 months. Participants will be recruited via online, email, and print advertisements. The investigators will obtain healthcare provider consent for each participant prior to randomization. The exercise intervention will consist of a theory-based telephone intervention shown to increase exercise among postpartum women in a previous study (Lewis et al., 2011). The wellness/support condition will be on the same schedule as the exercise intervention and will address several topics related to wellness. The usual care condition will receive their choice of the exercise or wellness/support condition upon completion of their final assessment. The primary dependent variable will be depression as measured by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and the Edinburgh Postnatal Depression Scale (EPDS). Exercise adherence will be assessed using the 7-Day Physical Activity Recall Interview and the ActiGraph (i.e., an accelerometer, an objective measure of exercise).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postpartum Depression
Intervention  ICMJE
  • Behavioral: Exercise
    Telephone-based intervention designed to increase exercise among postpartum women.
  • Behavioral: Wellness/Support
    Telephone-based intervention designed to provide support to postpartum women.
Study Arms  ICMJE
  • Experimental: Exercise
    Telephone-based intervention designed to increase exercise among postpartum women.
    Intervention: Behavioral: Exercise
  • Experimental: Wellness/Support
    Telephone-based intervention designed to provide support to postpartum women.
    Intervention: Behavioral: Wellness/Support
  • No Intervention: Usual care
    Participants receive usual care and will receive their choice of the interventions at 9 months.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
450
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy
  • Low active
  • Currently pregnant (who will wait to be randomized until postpartum) or less than six weeks postpartum
  • History of depression

Exclusion Criteria:

  • Less than 18 years of age
  • Pre-existing hypertension or diabetes
  • Currently exercising (defined as exercising more than 60 minutes per week)
  • Enrolled in another exercise or weight management study
  • Another member of the household participating in the study
  • Unable to exercise for 20 minutes continuously
  • Musculoskeletal problems such as arthritis, gout, osteoporosis, or back, hip or knee pain that may interfere with exercising
  • Exercise induced asthma
  • Any condition that would make exercise unsafe or unwise
  • Taking medication that interferes with heart rate response to exercise such as beta blockers
  • Hospitalization for a psychiatric disorder in the past six months
  • Current depressive episode (based on the SCID) and/or currently receiving antidepressant medication or psychotherapy for depression (participants who are depressed prior to randomization will be referred to their primary physician or psychiatrist)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883479
Other Study ID Numbers  ICMJE R01MH096748( U.S. NIH Grant/Contract )
R01MH096748 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Beth A Lewis, PhD University of Minnesota
PRS Account University of Minnesota
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP