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Sleep and Tracking Effects in Pregnancy Study

NCT04173559 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy Complications
  • Pregnancy Related
  • Weight Gain
  • Weight Change Trajectory
  • High Risk Pregnancy
  • Stress, Emotional

Interventions

BEHAVIORAL

Activity Intervention

After 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Tracy A Manuck, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
51 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-05-14
Completion
2025-05-14

Countries

  • United States

Study Locations

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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 NCT04173559 on ClinicalTrials.gov