Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT02474862
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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Notify Me18 year and older
Female
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PWP is a gentle walking intervention tailored for pregnant women.
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.
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.
Time frame: Change from baseline in physical activity level at week 10
Objective measurement using accelerometry and self-report
Time frame: Change from baseline in anxiety level at week 10
State Anxiety Scale
Time frame: Change from baseline in perceived stress at week 10
Perceived Stress Scale -10
Time frame: Change from baseline in health status at week 10
plasma interleukin-6 (IL-6)
Time frame: Change from baseline in health status at week 10
plasma IL-1 beta (IL-1β)
Time frame: (CRP).Change from baseline in health status at week 10
plasma tumor necrosis factor - alpha (TNF- α)
Time frame: Change from baseline in health status at week 10
serum high sensitivity C-reactive protein (CRP).
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
Time frame: Change from baseline in pain at week 10
Patient Reported Outcomes Measurement Information System (PROMIS)- Pain Short Form v1.0
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
Time frame: Change from baseline in pregnancy at week 10
Maternal Physical Discomfort Scale
Time frame: Change from baseline in quality of life at week 10
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Time frame: Change from baseline in attachment to the fetus at week 10
Maternal Antenatal Attachment Scale
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).
Butler Hospital
Other
RCT of a Tailored Walking Program to Reduce Stress Among Pregnant Women
Acronym: HE
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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