Stanford University
This randomized control trial will evaluate whether a physical activity intervention can improve mental health and biologic markers of stress in pregnant people with depressive or anxiety symptoms. The study will enroll participants if they are presenting for prenatal care at Stanford Children's Health Obstetrics Clinic with a singleton gestation.
Study Design This will be a randomized, parallel group, unblinded, single site superiority trial evaluating the impact of a physical activity intervention on reducing symptoms in people with known or screen-positivity for depression or anxiety during pregnancy. Participants will be randomized to a step count intervention versus usual care. Adherence will be monitored via Actigraph Link GT9X accelerometer watches. Primary outcome: The primary outcome will be the mean within-person change in EPDS score between Time 2 (randomization) and Time 3 (37 weeks). Secondary outcomes: Secondary outcomes…
Inclusion Criteria: * Able to read and write in English or Spanish * Presenting for a prenatal visit with a viable singleton gestation (no known lethal fetal anomaly or plan for pregnancy termination) between 18 and 20 weeks 0 days * Any history of depression or anxiety, defined as: 1) documented depression or anxiety in the medical record within the preceding 2 years; 2) baseline EPDS score \>=10 at intake prenatal visit; 3) baseline EPDS anxiety subscale 3A score \>=5 Exclusion Criteria: * Known allergy to steel or rubber * Implantable medical device * Contraindication to physical activit…
The step count goal will be discussed at the beginning of the study, and participants will be able to see their step count on the Actigraph watch to facilitate achieving this goal. All participants will receive weekly reminders that are tailored for their intervention arm. Intervention group participants will also receive a step count diary with motivational ideas of how to obtain step goals, which will be reviewed with a study team member every 2 weeks.
Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.
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