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Clinical Trials/NCT01883479
NCT01883479CompletedNot Applicable

Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.

University of Minnesota1 site in 1 country450 target enrollmentStarted: December 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
450
Locations
1
Primary Endpoint
Depression

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Exercise

Experimental

Telephone-based intervention designed to increase exercise among postpartum women.

Intervention: Exercise (Behavioral)

Wellness/Support

Experimental

Telephone-based intervention designed to provide support to postpartum women.

Intervention: Wellness/Support (Behavioral)

Usual care

No Intervention

Participants receive usual care and will receive their choice of the interventions at 9 months.

Outcomes

Primary Outcomes

Depression

Time Frame: 6 months

Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I

Secondary Outcomes

  • Depressive Symptoms(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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