Activity Intervention for Pregnancy Stress
(STEP Trial)
Trial Summary
What is the purpose of this trial?
Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy.Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth \<37 weeks' in a prior pregnancy.Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.
Research Team
Tracy Manuck, MD
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
This trial is for pregnant women at high risk of complications due to obesity or past issues like preeclampsia, with a stress score ≥14. They must be 8-19.9 weeks along in a single pregnancy without abnormalities, aged 18-51, speak English, and own a compatible smartphone.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Assessment
Participants complete dietary, stress, sleep, and body image questionnaires and provide initial biological samples
Intervention
Participants receive a wrist-based activity tracker and are randomized to either receive personalized counseling with weekly text messages or standard care
Follow-up
Participants are monitored for maternal and neonatal outcomes, with biological samples collected at delivery
Treatment Details
Interventions
- Activity Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor