Depressive SymptomsHENCT02474862
Healthy Expectations - a Program for Pregnant Women Experiencing Depressive Symptoms
A study testing Prenatal Walking Program and Postpartum Prep Program in people with Depressive Symptoms and Pregnancy, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depressive Symptoms, Pregnancy
- What is being tested?
- Prenatal Walking Program and Postpartum Prep Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2015to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms, Pregnancy
- Being tested
- Prenatal Walking Program, Postpartum Prep Program
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal Walking ProgramBehavioural
PWP is a gentle walking intervention tailored for pregnant women.
Postpartum Prep ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Postpartum Prep Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptom severity
The Quick Inventory of Depression Symptoms (QIDS) is the primary outcome measure and will be used to assess depression symptom severity.
Measured: Change from baseline in depression severity at week 10
Secondary outcomes (14)
Physical activity level
Objective measurement using accelerometry and self-report
Measured: Change from baseline in physical activity level at week 10
Anxiety
State Anxiety Scale
Measured: Change from baseline in anxiety level at week 10
Perceived stress
Perceived Stress Scale -10
Measured: Change from baseline in perceived stress at week 10
Health status - Inflammatory Biomarker 1
plasma interleukin-6 (IL-6)
Measured: Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 2
plasma IL-1 beta (IL-1β)
Measured: Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 3
plasma tumor necrosis factor - alpha (TNF- α)
Measured: (CRP).Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 4
serum high sensitivity C-reactive protein (CRP).
Measured: 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
Measured: Change from baseline in physical functioing at week 10
Physical Pain
Patient Reported Outcomes Measurement Information System (PROMIS)- Pain Short Form v1.0
Measured: Change from baseline in pain at week 10
Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Fatigue 8a Participant Version
Measured: Change from baseline in fatigue at week 10
Pregnancy discomfort
Maternal Physical Discomfort Scale
Measured: Change from baseline in pregnancy at week 10
Quality of life and satisfaction
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
Measured: Change from baseline in quality of life at week 10
Attachment to fetus/infant
Maternal Antenatal Attachment Scale
Measured: 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).
Measured: 30-days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study start24 Mar 2015
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Cynthia Battle, Butler Hospital
- Investigators
- Cynthia Battle, PhD, Principal investigator, Butler Hospitl/Brown Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474862
- Sponsor's protocol ID
- R01NR014540-01A1
- Acronym
- HE
- Status last verified
- Feb 2025
- First submitted
- 11 Jun 2015
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Tailored Walking Program to Reduce Stress Among Pregnant Women
- ClinicalTrials.gov ID
- NCT02474862
- Acronym / sponsor ID
- HE / R01NR014540-01A1
- Conditions
- Depressive Symptoms, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- Brown University, Women and Infants Hospital of Rhode Island
- Study start
- 24 Mar 2015 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Walking Program | Experimental | Behavioral: Prenatal Walking ProgramThe 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. |
| Postpartum Prep Program | Active comparator | Behavioral: Postpartum Prep ProgramIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal Walking ProgramPWP is a gentle walking intervention tailored for pregnant women. | Behavioural | Prenatal Walking Program |
| Postpartum Prep ProgramPPP 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. | Behavioural | Postpartum Prep Program |
Primary outcome
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.
14 secondary outcomes
Physical activity level
Time frame: Change from baseline in physical activity level at week 10
Anxiety
Time frame: Change from baseline in anxiety level at week 10
Perceived stress
Time frame: Change from baseline in perceived stress at week 10
Health status - Inflammatory Biomarker 1
Time frame: Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 2
Time frame: Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 3
Time frame: (CRP).Change from baseline in health status at week 10
Health status - Inflammatory Biomarker 4
Time frame: Change from baseline in health status at week 10
Physical functioning
Time frame: Change from baseline in physical functioing at week 10
Physical Pain
Time frame: Change from baseline in pain at week 10
Fatigue
Time frame: Change from baseline in fatigue at week 10
Pregnancy discomfort
Time frame: Change from baseline in pregnancy at week 10
Quality of life and satisfaction
Time frame: Change from baseline in quality of life at week 10
Attachment to fetus/infant
Time frame: Change from baseline in attachment to the fetus at week 10
Infant Outcome
Time frame: 30-days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Battle, PhD principal investigator
Butler Hospitl/Brown Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Walking Program and Postpartum Prep Program in people with Depressive Symptoms and Pregnancy, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptom severity (time frame: Change from baseline in depression severity at week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.