Providence, Rhode Island 02906


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. women aged 18 or over 2. 12-27 weeks gestation with a healthy singleton pregnancy 3. English-speaking 4. cleared by prenatal provider for moderate intensity exercise 5. 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: 1. 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 2. current/recent acute suicidal symptoms 3. current substance use disorder 4. psychotic symptoms or cognitive impairment 5. current eating disorder 6. 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: 7. current significant physical or neurological illness, ie., acute or chronic infectious, inflammatory or immune disorders 8. regular use of aspirin or non-steroidal anti-inflammatory drugs.


Study is Available At:


Original ID:

R01NR014540-01A1


NCT ID:

NCT02474862


Secondary ID:


Study Acronym:

HE


Brief Title:

Healthy Expectations - A Program for Pregnant Women Experiencing Depressive Symptoms


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Butler Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

152


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Cynthia Battle, PhD
Principal Investigator
Butler Hospitl/Brown Unversity
Primary Contact:Rita Rossi, MA
401-455-6303
rrossi@butler.org
Backup Contact:Brie Scott, BA
401-455-6303
bscott@butler.org

Study Dates

Start Date:March 2015
Completion Date:September 2020
Completion Type:Anticipated
Primary Completion Date:September 2020
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 29, 2019
First Received Date:June 11, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Infant Outcome
Time Frame:30-days postpartum
Safety Issues:False
Description: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).
Outcome Type:Secondary Outcome
Measure:Attachment to fetus/infant
Time Frame:Change from baseline in attachment to the fetus at week 10
Safety Issues:False
Description:Maternal Antenatal Attachment Scale
Outcome Type:Secondary Outcome
Measure:Quality of life and satisfaction
Time Frame:Change from baseline in quality of life at week 10
Safety Issues:False
Description:Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Outcome Type:Secondary Outcome
Measure:Pregnancy discomfort
Time Frame:Change from baseline in pregnancy at week 10
Safety Issues:False
Description:Maternal Physical Discomfort Scale
Outcome Type:Secondary Outcome
Measure:Fatigue
Time Frame:Change from baseline in fatigue at week 10
Safety Issues:False
Description:Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Fatigue 8a Participant Version
Outcome Type:Secondary Outcome
Measure:Physical Pain
Time Frame:Change from baseline in pain at week 10
Safety Issues:False
Description:Patient Reported Outcomes Measurement Information System (PROMIS)- Pain Short Form v1.0
Outcome Type:Secondary Outcome
Measure:Physical functioning
Time Frame:Change from baseline in physical functioing at week 10
Safety Issues:False
Description:Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Phys. Function 10a
Outcome Type:Secondary Outcome
Measure:Health status - Inflammatory Biomarker 4
Time Frame:Change from baseline in health status at week 10
Safety Issues:False
Description:serum high sensitivity C-reactive protein (CRP).
Outcome Type:Secondary Outcome
Measure:Health status - Inflammatory Biomarker 3
Time Frame:(CRP).Change from baseline in health status at week 10
Safety Issues:False
Description:plasma tumor necrosis factor - alpha (TNF- α)
Outcome Type:Secondary Outcome
Measure:Health status - Inflammatory Biomarker 2
Time Frame:Change from baseline in health status at week 10
Safety Issues:False
Description:plasma IL-1 beta (IL-1β)
Outcome Type:Secondary Outcome
Measure:Health status - Inflammatory Biomarker 1
Time Frame:Change from baseline in health status at week 10
Safety Issues:False
Description:plasma interleukin-6 (IL-6)
Outcome Type:Secondary Outcome
Measure:Perceived stress
Time Frame:Change from baseline in perceived stress at week 10
Safety Issues:False
Description:Perceived Stress Scale -10
Outcome Type:Secondary Outcome
Measure:Anxiety
Time Frame:Change from baseline in anxiety level at week 10
Safety Issues:False
Description:State Anxiety Scale
Outcome Type:Secondary Outcome
Measure:Physical activity level
Time Frame:Change from baseline in physical activity level at week 10
Safety Issues:False
Description:Objective measurement using accelerometry and self-report
Outcome Type:Primary Outcome
Measure:Depression symptom severity
Time Frame:Change from baseline in depression severity at week 10
Safety Issues:False
Description:The Quick Inventory of Depression Symptoms (QIDS) is the primary outcome measure and will be used to assess depression symptom severity.

Study Interventions

Intervention Type:Behavioral
Name:Prenatal Walking Program
Description:PWP is a gentle walking intervention tailored for pregnant women.
Arm Name:Prenatal Walking Program
Intervention Type:Behavioral
Name:Postpartum Prep Program
Description: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.
Arm Name:Postpartum Prep Program

Study Arms

Study Arm Type:Active Comparator
Arm Name:Postpartum Prep Program
Description: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.
Study Arm Type:Experimental
Arm Name:Prenatal Walking Program
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Butler Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Brown University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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