Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression
HM2
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 29, 2017
June 1, 2017
4.4 years
April 24, 2013
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Depression
Depression assessed by the The Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-I
6 months
Secondary Outcomes (1)
Depressive Symptoms
6 months
Study Arms (3)
Exercise
EXPERIMENTALTelephone-based intervention designed to increase exercise among postpartum women.
Wellness/Support
EXPERIMENTALTelephone-based intervention designed to provide support to postpartum women.
Usual care
NO INTERVENTIONParticipants receive usual care and will receive their choice of the interventions at 9 months.
Interventions
Telephone-based intervention designed to increase exercise among postpartum women.
Telephone-based intervention designed to provide support to postpartum women.
Eligibility Criteria
You may qualify if:
- Generally healthy
- Low active
- Currently pregnant (who will wait to be randomized until postpartum) or less than six weeks postpartum
- History of depression
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Lewis BA, Schuver K, Dunsiger S, Samson L, Frayeh AL, Terrell CA, Ciccolo JT, Fischer J, Avery MD. Randomized trial examining the effect of exercise and wellness interventions on preventing postpartum depression and perceived stress. BMC Pregnancy Childbirth. 2021 Nov 22;21(1):785. doi: 10.1186/s12884-021-04257-8.
PMID: 34802425DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beth A Lewis, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2013
First Posted
June 21, 2013
Study Start
December 1, 2012
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 29, 2017
Record last verified: 2017-06