Activity Intervention for Pregnancy Stress

(STEP Trial)

Overseen By Tracy A Manuck, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Multifetal gestations, Medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

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

At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)

I am a woman aged between 18 and 51.

I own a smartphone that works with a wrist activity tracker.

Exclusion Criteria

Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week

Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)

Planned delivery prior to 36 weeks' of gestation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Enrollment and Baseline Assessment

Participants complete dietary, stress, sleep, and body image questionnaires and provide initial biological samples

1-2 weeks

1 visit (in-person)

Intervention

Participants receive a wrist-based activity tracker and are randomized to either receive personalized counseling with weekly text messages or standard care

7 months

Regular prenatal visits (in-person), weekly virtual check-ins for intervention group

Follow-up

Participants are monitored for maternal and neonatal outcomes, with biological samples collected at delivery

6 weeks postpartum

1 visit (in-person) at delivery, follow-up assessments

Treatment Details

Interventions

• Activity Intervention

Trial Overview The study tests if using a wrist-based activity tracker and receiving enhanced counseling can reduce stress and improve outcomes during pregnancy compared to standard care. Participants will fill out questionnaires and provide blood samples for analysis.

Participant Groups

Group I: Activity Intervention Experimental Treatment 1 Intervention

Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .

Group II: Usual care Active Control 1 Intervention

Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+