Healthy Expectations - a Program for Pregnant Women Experiencing Depressive Symptoms

NCT02474862 | Completed DMC

• 1 other identifier: R01NR014540-01A1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP) in comparison to a Postpartum Prep Program (PPP) comparison group for pregnant women experiencing depressive symptoms. In addition to assessing changes in depressive symptoms, the investigators will examine other key maternal outcomes (maternal functioning, pain, anxiety, stress, fatigue), as well as infant outcomes including birth record data (gestation, weight, Apgar scores, etc) and careful, in-person assessment of infant neurobiological functioning at 30 days postpartum.

Conditions

Depressive Symptoms; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Depression symptom severity

  The Quick Inventory of Depression Symptoms (QIDS) is the primary outcome measure and will be used to assess depression symptom severity.

  Change from baseline in depression severity at week 10

Secondary Outcomes (14)

• Physical activity level

  Change from baseline in physical activity level at week 10

• Anxiety

  Change from baseline in anxiety level at week 10

• Perceived stress

  Change from baseline in perceived stress at week 10

• Health status - Inflammatory Biomarker 1

  Change from baseline in health status at week 10

• Health status - Inflammatory Biomarker 2

  Change from baseline in health status at week 10

Study Arms (2)

Prenatal Walking Program

EXPERIMENTAL

The Prenatal Walking Program (PWP) is a gentle walking intervention tailored for pregnant women. The PWP intervention consists of 3 components: 1) biweekly session with a study interventionist; 2) the use of activity monitors to increase motivation and self-monitoring; 3) incentives to promote intervention adherence.

Behavioral: Prenatal Walking Program

Postpartum Prep Program

ACTIVE COMPARATOR

In the Postpartum Prep Program control condition (PPP) participants will attend individually education sessions matched in number and duration to the sessions in PWP. PPP involves providing health information particularly relevant to expectant mothers, including both maternal and newborn wellbeing.

Behavioral: Postpartum Prep Program

Interventions

Prenatal Walking Program BEHAVIORAL

PWP is a gentle walking intervention tailored for pregnant women.

Prenatal Walking Program

Postpartum Prep Program BEHAVIORAL

PPP participants will attend individually education sessions matched in number and duration to the sessions in PWP. PPP involves providing health information particularly relevant to expectant mothers, including both maternal and newborn well being.

Postpartum Prep Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 18 or over
• weeks gestation with a healthy singleton pregnancy
• English-speaking
• cleared by prenatal provider for moderate intensity exercise
• experiencing moderate depressive symptom elevations at time of enrollment (QIDS-C; 8-20); (6) physically inactive or low-active at time of enrollment (mean \< 90 minutes/week of moderate intensity exercise, over the last 3 months).

You may not qualify if:

• recently started pharmacologic or psychosocial treatment for depressive symptoms within the past 4 weeks, or recently changed dose or treatment regimen in the past 4 weeks
• current/recent acute suicidal symptoms
• current substance use disorder
• psychotic symptoms or cognitive impairment
• current eating disorder
• current or lifetime bipolar disorder, schizophrenia, or schizoaffective disorder.
• Finally, while the following will not exclude participants from enrollment in the study, women meeting these two criteria will be excluded from participating in the blood draw component examining inflammatory markers:
• current significant physical or neurological illness, ie., acute or chronic infectious, inflammatory or immune disorders
• regular use of aspirin or non-steroidal anti-inflammatory drugs.

Sponsors & Collaborators

• Butler Hospital: lead
• Brown University: collaborator
• Women and Infants Hospital of Rhode Island: collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Cynthia Battle, PhD

  Butler Hospitl/Brown Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 18, 2015
• Study Start: March 24, 2015
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)