## Protocol Section
### Identification Module
**NCT ID:** NCT01883479

**Acronym:** HM2

**Brief Title:** Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression

**Official Title:** Effect of Exercise and Wellness Interventions on Preventing Postpartum Depression.

#### Organization Study ID Info
**ID:** R01MH096748
**Link:** https://reporter.nih.gov/quickSearch/R01MH096748
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Minnesota
#### Secondary ID Infos
**ID:** R01MH096748
**Link:** https://reporter.nih.gov/quickSearch/R01MH096748
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2017-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-06-29

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2013-06-21
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-24
**Study First Submit QC Date:** 2013-06-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Minnesota

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Postpartum Depression

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 450

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Exercise

**Label:** Exercise

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Telephone-based intervention designed to provide support to postpartum women.

**Intervention Names:**

- Behavioral: Wellness/Support

**Label:** Wellness/Support

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Label:** Usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exercise

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

**Name:** Exercise

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Wellness/Support

**Description:** Telephone-based intervention designed to provide support to postpartum women.

**Name:** Wellness/Support

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Depression

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Depressive symptoms as assessed by the PHQ-9

**Measure:** Depressive Symptoms

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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)

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Minneapolis

**Country:** United States

**Facility:** University of Minnesota

**State:** Minnesota

**Zip:** 55455

#### Overall Officials

**Official 1:**

**Affiliation:** University of Minnesota

**Name:** Beth A Lewis, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 34802425

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: HIGH

- As Found: Depression

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depression

- ID: M21076

- Name: Depression, Postpartum

- Relevance: HIGH

- As Found: Postpartum Depression

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019052

- Term: Depression, Postpartum

- ID: D000003863

- Term: Depression

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-24
