Healthy Expectations - a Program for Pregnant Women Experiencing Depressive Symptoms
NCT ID: NCT02474862
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2015-03-24
2020-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Prenatal Walking Program
PWP is a gentle walking intervention tailored for pregnant women.
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.
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.
Interventions
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Prenatal Walking Program
PWP is a gentle walking intervention tailored for pregnant women.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Brown University
OTHER
Women and Infants Hospital of Rhode Island
OTHER
Butler Hospital
OTHER
Responsible Party
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Cynthia Battle
Associate Professor (Research)
Principal Investigators
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Cynthia Battle, PhD
Role: PRINCIPAL_INVESTIGATOR
Butler Hospitl/Brown Unversity
Locations
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Butler Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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