The Effect of Exercise on Preventing PostPartum Depression

NCT00961402 | Completed Phase 2 Results

• 2 other identifiers: 0903S61462R21MH085176
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the feasibility and efficacy of an exercise intervention for the prevention of postpartum depression. If efficacious, our intervention could be disseminated in "real world settings" in an effort to prevent postpartum depression.

Conditions

PostPartum Depression

Keywords

Exercise; PostParum Depression

Outcome Measures

Primary Outcomes (1)

• Structured Clinical Interview for DSM-IV Axis I Disorders

  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.

  6 months

Secondary Outcomes (3)

• 7-Day Physical Activity Recall Interview

  6 months

• Edinburgh Postnatal Depression Scale

  6 Months

• PHQ-9

  6 Months

Study Arms (2)

Wellness Control

EXPERIMENTAL

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

Behavioral: Wellness Control

Exercise Intervention

EXPERIMENTAL

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

Behavioral: Exercise Intervention

Interventions

Wellness Control BEHAVIORAL

6-month wellness control

Wellness Control

Exercise Intervention BEHAVIORAL

6 month exercise intervention

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will recruit healthy, sedentary (defined as exercising 60 minutes or less per week) women who are at least 18 years of age and at least 28 weeks pregnant or less than one month postpartum (n=120). Participants will be required to obtain written consent from their healthcare provider to participate. This written consent will be obtained following delivery of the newborn. Participants will complete a telephone screening interview to assess eligibility. Current depressive episode will be assessed using the PHQ-9 (cut-off will be 10 or higher). As we have done in previous trials, we will have a protocol in place that deals with participants expressing suicidal ideation ranging from referring them to their healthcare provider and/or calling emergency assistance, depending on intent. To be included, participants must be willing to be randomly assigned to either of the two study arms. Additionally, participants will read and sign a consent form approved by the University of Minnesota and have all of their questions will be answered prior to participating.

You may not qualify if:

• No healthcare provider consent to participate
• Pre-existing hypertension or diabetes
• Current participation in exercise (defined as exercising 60 or more minutes per week)
• Currently enrolled in another exercise or weight management study
• Less than 18 years of age
• Another member of household participating in the study
• Unable to speak, comprehend, read, or write fluently in the English language
• Unable to walk for 30 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 and/or currently receiving antidepressant medication or psychotherapy for depression (those who are depressed and who are not in treatment will be referred to their physician or psychiatrist for follow-up care)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Lewis BA, Gjerdingen D, Schuver K, Avery M, Marcus BH. The effect of sleep pattern changes on postpartum depressive symptoms. BMC Womens Health. 2018 Jan 9;18(1):12. doi: 10.1186/s12905-017-0496-6.

  PMID: 29316912 DERIVED

• Lewis BA, Billing L, Schuver K, Gjerdingen D, Avery M, Marcus BH. The relationship between employment status and depression symptomatology among women at risk for postpartum depression. Womens Health (Lond). 2017 Apr;13(1):3-9. doi: 10.1177/1745505717708475. Epub 2017 May 7.

  PMID: 28480799 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Motor Activity

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Beth Lewis
• Organization: University of Minnesota

blewis@umn.edu

612-625-0756

Study Officials

• Beth A Lewis, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 18, 2019
• Results First Posted: July 29, 2016

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)