Healthy Expectations - A Program for Pregnant Women Experiencing Depressive Symptoms (HE)

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

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 Overview

• Status: Completed
• Conditions: Pregnancy; Depressive Symptoms
• Intervention / Treatment: Behavioral: Prenatal Walking Program; Behavioral: Postpartum Prep Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prenatal Walking Program; 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; PWP is a gentle walking intervention tailored for pregnant women.
Active Comparator: Postpartum Prep Program; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: Brown University; Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Cynthia Battle, PhD, Butler Hospitl/Brown Unversity

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2015
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R01NR014540-01A1 (U.S. NIH Grant/Contract)