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Completed

NCT Number: NCT02474862

Healthy Expectations - a Program for Pregnant Women Experiencing Depressive Symptoms

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

Depressive symptoms are prevalent among pregnant women, and they are consistently linked with adverse outcomes for both women and infants, including higher rates of spontaneous abortion, preeclampsia, operative delivery, and postpartum depression. Additional risks to offspring include pre-term delivery, neonatal growth retardation, low birth weight, and delayed developmental milestones. In spite of these risks, the vast majority of affected women do not pursue any type of mental health treatment. Many women are reluctant to use antidepressants - or anything that could potentially harm the baby - prenatally. Because pregnant women have unique concerns regarding treatment acceptability, a critical need exists to develop interventions that are not only efficacious in reducing depressive symptoms, but are also viewed as acceptable by pregnant women.

Increased physical activity has numerous advantages as a strategy for improving mood during pregnancy, and prior research has shown that physical activity interventions can be effective in treating depressive symptoms in the general population. Physical activity interventions are also inexpensive, safe, and associated with a variety of positive health outcomes.

In spite of its potential as an acceptable and efficacious strategy for improving prenatal mood, few studies have evaluated physical activity as an intervention for pregnant women with depressive symptoms. Existing exercise programs that have been tested for reducing depressive symptoms in the general population are not likely to be appropriate or feasible for pregnant women. In light of this important gap, the investigators interdisciplinary team developed a gentle, 10-week, pedometer walking intervention tailored for pregnant women, the Prenatal Walking Program (PWP) and preliminarily evaluated PWP in an open trial, finding the intervention to be safe, feasible, and acceptable.

The current RCT will now evaluate PWP in comparison to a health education control comparison group tailored for perinatal women, called the Postpartum Prep Program (PPP). 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 and in-person assessment of infant neurobiological functioning. Further, the investigators will examine evidence for potential behavioral, psychological, and biological mechanisms of action that mediate a possible treatment effect. Up to 152 pregnant women reporting elevated depressive symptoms during the current pregnancy will be enrolled and randomized into one of two groups, PWP or PPP, and will participate in blinded follow-up evaluations at multiple time-points throughout pregnancy and postpartum.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women aged 18 or over
  • 12-27 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).

Exclusion criteria

  • 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.

Treatment and study plan

Prenatal Walking Program

Behavioral

PWP is a gentle walking intervention tailored for pregnant women.

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.

Primary outcomes

  1. Depression symptom severity

    Time frame: Change from baseline in depression severity at week 10

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

Secondary outcomes

  1. Physical activity level

    Time frame: Change from baseline in physical activity level at week 10

    Objective measurement using accelerometry and self-report

  2. Anxiety

    Time frame: Change from baseline in anxiety level at week 10

    State Anxiety Scale

  3. Perceived stress

    Time frame: Change from baseline in perceived stress at week 10

    Perceived Stress Scale -10

  4. Health status - Inflammatory Biomarker 1

    Time frame: Change from baseline in health status at week 10

    plasma interleukin-6 (IL-6)

  5. Health status - Inflammatory Biomarker 2

    Time frame: Change from baseline in health status at week 10

    plasma IL-1 beta (IL-1β)

  6. Health status - Inflammatory Biomarker 3

    Time frame: (CRP).Change from baseline in health status at week 10

    plasma tumor necrosis factor - alpha (TNF- α)

  7. Health status - Inflammatory Biomarker 4

    Time frame: Change from baseline in health status at week 10

    serum high sensitivity C-reactive protein (CRP).

  8. Physical functioning

    Time frame: Change from baseline in physical functioing at week 10

    Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Phys. Function 10a

  9. Physical Pain

    Time frame: Change from baseline in pain at week 10

    Patient Reported Outcomes Measurement Information System (PROMIS)- Pain Short Form v1.0

  10. Fatigue

    Time frame: Change from baseline in fatigue at week 10

    Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Fatigue 8a Participant Version

  11. Pregnancy discomfort

    Time frame: Change from baseline in pregnancy at week 10

    Maternal Physical Discomfort Scale

  12. Quality of life and satisfaction

    Time frame: Change from baseline in quality of life at week 10

    Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

  13. Attachment to fetus/infant

    Time frame: Change from baseline in attachment to the fetus at week 10

    Maternal Antenatal Attachment Scale

  14. Infant Outcome

    Time frame: 30-days postpartum

    This outcome will be based on a composite of measures relating to labor & delivery outcomes (e.g. gestational age) and infant neurobehavioral functioning (i.e., the Neonatal Intensive Care Unit Network Neurobehavioral Scale; NNNS).

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

RCT of a Tailored Walking Program to Reduce Stress Among Pregnant Women

Acronym: HE

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 18, 2015
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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