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Psychobiological Interventions in Pregnancy

NCT06430853 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

Step count goal

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.

DEVICE

Actigraph watch

Both groups will wear the watch. Adherence will be assessed via step counts from accelerometer watch.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Danielle M Panelli, MD, MS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2027-01-01
Completion
2027-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06430853 on ClinicalTrials.gov