Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04173559
Brief 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.
Detailed Description:
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention.
Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.
Study:
NCT04173559
Study Brief:
Protocol Section:
NCT04173559