Psychobiological Interventions in Pregnancy

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06430853
Status
Enrolling By Invitation

Conditions

  • Biological Clock Disturbance
  • Depression, Anxiety
  • Mental Health Issue
  • Pregnancy Complications
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Step count goal — BEHAVIORAL
    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.
  • Actigraph watch — DEVICE
    Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.

Study Details

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.

Key Dates

Start date
Jan 13, 2025
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Usual step count
    Participants will wear an Actigraph accelerometer watch, but not be given a step count goal, between 20 and 36 weeks of gestation.
  • Experimental: Step count goal
    Participants will be given a daily step count goal of 8,000 steps per day based on the Actigraph watch, between 20 and 36 weeks of gestation. If they are not at goal, a step-up protocol will be designed for each participant and reviewed with a study team member every 2 weeks.

Primary Outcome Measure

Change in Edinburgh Postpartum Depression Scale (EPDS) Score [ Time Frame: Randomization around 20 weeks gestation and end of study (around 37 weeks gestation). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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Stanford University· Stanford, CA

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